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quetiapine fumarate

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth

Description

Quetiapine Fumarate: A dibenzothiazepine and ANTIPSYCHOTIC AGENT that targets the SEROTONIN 5-HT2 RECEPTOR; HISTAMINE H1 RECEPTOR, adrenergic alpha1 and alpha2 receptors, as well as the DOPAMINE D1 RECEPTOR and DOPAMINE D2 RECEPTOR. It is used in the treatment of SCHIZOPHRENIA; BIPOLAR DISORDER and DEPRESSIVE DISORDER. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID25058200
MeSH IDM0398083

Synonyms (4)

Synonym
seroquel
quetiapine fumarate
2-(2-(4-dibenzo(b,f)(1,4)thiazepin-11-yl-1-piperazinyl)ethoxy)ethanol fumarate (2:1) (salt)
bis{2-[2-(4-dibenzo[b,f][1,4]thiazepin-11-ylpiperazin-1-yl)ethoxy]ethanol} (2e)-but-2-enedioate

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" Thus, clinicians should address patients' concerns about adverse effects and attempt to choose medications that will improve their patients' quality of life as well as overall health."( Adverse effects of the atypical antipsychotics. Collaborative Working Group on Clinical Trial Evaluations.
, 1998
)
0.3
" Nevertheless, clinical trials currently available suggest that quetiapine has a beneficial side effect profile, particularly with regard,to extrapyramidal symptoms."( Review of quetiapine side effects.
Garver, DL, 2000
)
0.31
" Their adverse effects, which include extrapyramidal side effects, tardive dyskinesia, weight gain, sedation, and sexual dysfunction, often lead to non-compliance; their use may have a negative impact on the overall course of illness; and they may not be as effective as lithium in treating the core manic symptoms over the long term."( Antipsychotic drug side effect issues in bipolar manic patients.
Zarate, CA, 2000
)
0.31
" Quetiapine is associated with high levels of patient acceptability and satisfaction, which may result from its combination of efficacy and relatively benign adverse effect profile."( Quetiapine: a review of its safety in the management of schizophrenia.
Dev, V; Raniwalla, J, 2000
)
0.31
" Doses were adjusted to maximize efficacy and to minimize adverse events."( A comparison of the relative safety, efficacy, and tolerability of quetiapine and risperidone in outpatients with schizophrenia and other psychotic disorders: the quetiapine experience with safety and tolerability (QUEST) study.
Jibson, MD; Mullen, J; Sweitzer, D, 2001
)
0.31
" The most common adverse events in the quetiapine and risperidone groups were somnolence (31."( A comparison of the relative safety, efficacy, and tolerability of quetiapine and risperidone in outpatients with schizophrenia and other psychotic disorders: the quetiapine experience with safety and tolerability (QUEST) study.
Jibson, MD; Mullen, J; Sweitzer, D, 2001
)
0.31
"Psychopharmacology research aims to expand the therapeutic ratio between efficacy, on the one hand, and adverse events and safety, on the other."( Psychotropic drugs and adverse events in the treatment of bipolar disorders revisited.
McIntyre, RS, 2002
)
0.31
"The effects of haloperidol, risperidone, and thioridazine on the pharmacokinetics and side-effect profile of quetiapine were investigated in 36 patients with schizophrenia, schizoaffective disorder, or bipolar disorder in a single-center, two-period, multiple-dose, open-label, randomized trial."( The safety and pharmacokinetics of quetiapine when coadministered with haloperidol, risperidone, or thioridazine.
Alva, G; Arvanitis, LA; Bera, R; Potkin, SG; Thyrum, PT; Yeh, C, 2002
)
0.31
" The new generation of atypical antipsychotics introduced over the past decade have comparable or greater efficacy than traditional antipsychotics in treating the psychotic symptoms of schizophrenia and a much improved neurologic side effect profile."( Efficacy, safety, and tolerability of quetiapine in patients with schizophrenia.
Nasrallah, HA; Tandon, R, 2002
)
0.31
" This is because of their efficacy in the treatment of several psychiatric disorders, ease of administration, and absence of the well-known extrapyramidal adverse effects long-attributed to the standard dopamine blocking anti-psychotic medications."( Atypical psychotropic medications and their adverse effects: a review for the African-American primary care physician.
Bailey, RK, 2003
)
0.32
"Quetiapine is a novel, atypical antipsychotic agent that has been shown to provide long-term efficacy without serious adverse effects in adults."( Long-term safety, tolerability, and clinical efficacy of quetiapine in adolescents: an open-label extension trial.
Browne, K; Carrero, L; Chaney, R; Foster, K; Friedman, L; McConville, B; Potter, L; Sorter, M; Sweitzer, D, 2003
)
0.32
" The aim of this paper is to review literature about newer antipsychotics, focusing on their advantages in terms of efficacy and side effect profiles when compared to classical and older atypical antipsychotics, and to evaluate the efficacy of the different new antipsychotics when compared to one another."( New antipsychotics and schizophrenia: a review on efficacy and side effects.
Berardi, D; De Ronchi, D; Lorenzi, C; Serretti, A, 2004
)
0.32
" While typical antipsychotics are often switched to atypical agents when adverse effects become limiting, there is little preclinical information to support this strategy, both in terms of efficacy and side effects."( Combined treatment of quetiapine with haloperidol in animal models of antipsychotic effect and extrapyramidal side effects: comparison with risperidone and chlorpromazine.
Matsuoka, N; Mutoh, S; Shirakawa, K; Tada, M, 2004
)
0.32
" Furthermore, quetiapine was well tolerated throughout the study period, with a low incidence of extrapyramidal symptom-related adverse events."( Maintenance of long-term efficacy and safety of quetiapine in the open-label treatment of schizophrenia.
Brecher, M; Fitton, L; Jones, AM; Kasper, S, 2004
)
0.32
"Five new antipsychotic drugs introduced in the United States in the last decade offer physicians the ability to treat patients with schizophrenia and bipolar mania without the adverse effects of the first-generation antipsychotics."( The promise of atypical antipsychotics: fewer side effects mean enhanced compliance and improved functioning.
Citrome, L; Volavka, J, 2004
)
0.32
" The most common adverse events for quetiapine were dry mouth, somnolence, and weight gain, while lithium was associated with tremor and insomnia."( A randomized, double-blind, placebo-controlled efficacy and safety study of quetiapine or lithium as monotherapy for mania in bipolar disorder.
Bowden, CL; Brecher, M; Grunze, H; Jones, M; Mullen, J; Paulsson, B; Svensson, K; Vågerö, M, 2005
)
0.33
" However, there are still significant adverse effects and toxicities with this class of medications."( Toxicology and overdose of atypical antipsychotic medications in children: does newer necessarily mean safer?
Dubois, D, 2005
)
0.33
"Continued research to evaluate adverse effects and tolerability of atypical antipsychotics compared with first-generation antipsychotics and each other is reviewed."( Toxicology and overdose of atypical antipsychotic medications in children: does newer necessarily mean safer?
Dubois, D, 2005
)
0.33
"While new atypical antipsychotic medications may have a safer therapeutic and overdose profile than first-generation antipsychotic medications, many adverse and toxic effects still need to be considered in therapeutic monitoring and overdose management."( Toxicology and overdose of atypical antipsychotic medications in children: does newer necessarily mean safer?
Dubois, D, 2005
)
0.33
"Quetiapine, an atypical antipsychotic, is effective for psychosis in younger patients, with limited adverse effects reported."( The efficacy and safety of quetiapine for treatment of geriatric psychosis.
Hwang, JP; Tsai, SJ; Yang, CH, 2005
)
0.33
"These data agree with recent clinical reports concerning the direct or mediated toxic effects of olanzapine on progenitor and committed cells (GM-CFU) and suggest that the correlation between its plasma levels and clinical effects warrants further investigation."( In vitro toxicity of clozapine, olanzapine, and quetiapine on granulocyte-macrophage progenitors (GM-CFU).
Bareggi, S; Bonomi, A; Cavicchini, L; Croera, C; Guizzardi, F; Pessina, A; Turlizzi, E, 2006
)
0.33
" Several clinical trials have not shown efficacy, and there have been concerns about adverse events."( Efficacy and adverse effects of atypical antipsychotics for dementia: meta-analysis of randomized, placebo-controlled trials.
Dagerman, K; Insel, PS; Schneider, LS, 2006
)
0.33
" Clinical and trials characteristics, outcomes, and adverse events were extracted."( Efficacy and adverse effects of atypical antipsychotics for dementia: meta-analysis of randomized, placebo-controlled trials.
Dagerman, K; Insel, PS; Schneider, LS, 2006
)
0.33
" Adverse events were mainly somnolence and urinary tract infection or incontinence across drugs, and extrapyramidal symptoms or abnormal gait with risperidone or olanzapine."( Efficacy and adverse effects of atypical antipsychotics for dementia: meta-analysis of randomized, placebo-controlled trials.
Dagerman, K; Insel, PS; Schneider, LS, 2006
)
0.33
" Dropouts and adverse events further limit effectiveness."( Efficacy and adverse effects of atypical antipsychotics for dementia: meta-analysis of randomized, placebo-controlled trials.
Dagerman, K; Insel, PS; Schneider, LS, 2006
)
0.33
" There are also continued efforts to understand, predict and manage the side-effect risk with quetiapine."( Quetiapine: efficacy, tolerability and safety in schizophrenia.
Lerner, V; Miodownik, C, 2006
)
0.33
" Endocrine and metabolic adverse effects are among the most concerning adverse effects of commonly used psychotropic medications."( Endocrine and metabolic adverse effects of psychotropic medications in children and adolescents.
Carlson, HE; Correll, CU, 2006
)
0.33
"Clinicians and caregivers need to be aware of potential endocrine and metabolic adverse effects of psychiatric medications."( Endocrine and metabolic adverse effects of psychotropic medications in children and adolescents.
Carlson, HE; Correll, CU, 2006
)
0.33
" No patients discontinued because of an adverse event."( Effectiveness, safety, and pharmacokinetics of quetiapine in aggressive children with conduct disorder.
Demeter, CA; Findling, RL; McNamara, NK; O'Riordan, MA; Reed, MD; Stansbrey, RJ, 2006
)
0.33
" Adverse event reporting, Simpson Angus Scale (SAS), and Barnes Akathisia Rating Scale (BARS) scores were recorded."( Safety and tolerability of quetiapine in the treatment of acute mania in bipolar disorder.
Adler, CM; Brecher, M; Fleck, DE; Strakowski, SM, 2007
)
0.34
"Most adverse events were mild to moderate."( Safety and tolerability of quetiapine in the treatment of acute mania in bipolar disorder.
Adler, CM; Brecher, M; Fleck, DE; Strakowski, SM, 2007
)
0.34
" Safety evaluations included the incidence of extrapyramidal symptoms (EPS) and adverse events (AEs)."( Quetiapine versus risperidone in elderly patients with behavioural and psychological symptoms of dementia: efficacy, safety and cognitive function.
Haushofer, M; Pfolz, H; Rainer, M; Struhal, C; Wick, W, 2007
)
0.34
" Safety outcome measures were all new clinical adverse events between the start of treatment (which could be before April 2003) and 30 November 2004."( Safety and usage of atypical antipsychotic medicines in children: a nationwide prospective cohort study.
Ashton, J; Garcia-Quiroga, J; Harrison-Woolrych, M; Herbison, P, 2007
)
0.34
" A total of 131 (31%) children experienced an adverse event."( Safety and usage of atypical antipsychotic medicines in children: a nationwide prospective cohort study.
Ashton, J; Garcia-Quiroga, J; Harrison-Woolrych, M; Herbison, P, 2007
)
0.34
" This was also the most frequently reported specified adverse drug reaction (ADR) to quetiapine (7; 11% of 65 reported ADRs) and the highest reported clinical reason for stopping quetiapine (51; 6% of the 734 reported reasons for stopping)."( The safety of quetiapine: results of a post-marketing surveillance study on 1728 patients in England.
Shakir, SA; Twaites, BR; Wilton, LV, 2007
)
0.34
" Adverse events, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests were evaluated throughout the studies."( Steady-state pharmacokinetic, safety, and tolerability profiles of quetiapine, norquetiapine, and other quetiapine metabolites in pediatric and adult patients with psychotic disorders.
Davis, PC; Earley, WR; Hamer-Maansson, JE; Smith, MA; Winter, HR, 2008
)
0.35
" Quetiapine was well tolerated, with no serious adverse events and no unexpected events reported."( Steady-state pharmacokinetic, safety, and tolerability profiles of quetiapine, norquetiapine, and other quetiapine metabolites in pediatric and adult patients with psychotic disorders.
Davis, PC; Earley, WR; Hamer-Maansson, JE; Smith, MA; Winter, HR, 2008
)
0.35
" In addition, adverse events were also evaluated."( [A naturalistic, observational study of outpatients with schizophrenia: efficacy and safety results after 6 months. The International Schizophrenia Outpatient Health Outcomes study, IC-SOHO].
Agoston, T; István, S; Tamás, T; Zoltán, J, 2007
)
0.34
" During the randomization phase, the most common adverse events occurring in > or =5% in the quetiapine group were somnolence, nasopharyngitis, and headache."( Efficacy and safety of quetiapine in combination with lithium or divalproex for maintenance of patients with bipolar I disorder (international trial 126).
Brecher, M; Eggens, I; Paulsson, B; Persson, I; Suppes, T; Vieta, E, 2008
)
0.35
" Based on recent criteria for pediatric populations, patients were considered "at risk for adverse health outcome" if they met at least 1 of the following criteria: (1) > or = 85th BMI percentile plus presence of 1 or more negative weight-related clinical outcomes, or (2) > or = 95th BMI percentile."( Metabolic and hormonal side effects in children and adolescents treated with second-generation antipsychotics.
Arango, C; Cifuentes, A; Fraguas, D; Giráldez, M; Laita, P; Merchán-Naranjo, J; Moreno, D; Parellada, M; Ruiz-Sancho, A, 2008
)
0.35
" The number of patients at risk for adverse health outcome increased from 11 (16."( Metabolic and hormonal side effects in children and adolescents treated with second-generation antipsychotics.
Arango, C; Cifuentes, A; Fraguas, D; Giráldez, M; Laita, P; Merchán-Naranjo, J; Moreno, D; Parellada, M; Ruiz-Sancho, A, 2008
)
0.35
" The 2 cases direct our attention to at least 3 important points regarding safe administration of ECT shortly after the occurrence of PE, that is, careful evaluation of cardiac function and residual deep vein thrombosis before the start of an ECT course, adjustment of anticoagulants, and prevention of recurrent deep vein thrombosis and PE by methods in addition to anticoagulant therapy (fluid infusion, use of support hose, and timely ECT)."( Safety of electroconvulsive therapy in psychiatric patients shortly after the occurrence of pulmonary embolism.
Fujiyama, K; Matsuoka, H; Suzuki, K; Takamatsu, K; Takano, T; Tanabe, Y, 2008
)
0.35
"Our study in acutely ill drug-naive first-episode psychosis patients suggests that quetiapine is a safe and well-tolerated antipsychotic medication."( Dosing quetiapine in drug-naive first-episode psychosis: a controlled, double-blind, randomized, single-center study investigating efficacy, tolerability, and safety of 200 mg/day vs. 400 mg/day of quetiapine fumarate in 141 patients aged 15 to 25 years.
Amminger, PG; Berger, GE; Kerr, M; Lubman, D; Markulev, C; McConchie, M; McGorry, PD; O'Donnell, C; Polari, A; Proffitt, TM; Wood, S; Yuen, HP, 2008
)
0.35
" The most common adverse events were sedation (54%), dry mouth (38%) and dizziness (29%)."( Efficacy, safety and tolerability of quetiapine augmentation in treatment resistant depression: an open-label, pilot study.
Anderson, IM; Haddad, PM; Sarsfield, A, 2009
)
0.35
"Second-generation antipsychotics (SGAs) are far more commonly used in the United States compared to first-generation antipsychotics (FGAs), but the relative safety of SGAs compared to FGAs following acute toxic ingestions has not been studied."( Comparing acute toxicity of first- and second-generation antipsychotic drugs: a 10-year, retrospective cohort study.
Ciranni, MA; Kearney, TE; Olson, KR, 2009
)
0.35
" Cases were coded for overall severity of adverse outcome as defined by the American Association of Poison Control Centers criteria and for presence of specific symptoms and treatments."( Comparing acute toxicity of first- and second-generation antipsychotic drugs: a 10-year, retrospective cohort study.
Ciranni, MA; Kearney, TE; Olson, KR, 2009
)
0.35
" During the treatment with quetiapine the patient presented complains about adverse effects like weight gain and somnolence."( [Psychodynamic psychopharmacology in clinical practice--interpretations of adverse events of pharmacotherapy. Case report].
Murawiec, S,
)
0.13
"In some cases adverse events of medication have not only biological but also emotional roots."( [Psychodynamic psychopharmacology in clinical practice--interpretations of adverse events of pharmacotherapy. Case report].
Murawiec, S,
)
0.13
" The most common adverse events were sedation, somnolence, and dry mouth."( Safety and efficacy of quetiapine in bipolar depression.
Bogart, GT; Chavez, B, 2009
)
0.35
"Based on the literature reviewed here, quetiapine appears to be a safe and efficacious short-term treatment option for bipolar depression."( Safety and efficacy of quetiapine in bipolar depression.
Bogart, GT; Chavez, B, 2009
)
0.35
" We describe two patients who experienced serious quetiapine adverse effects potentially mediated through an interaction with ritonavir-boosted atazanavir."( Clinically significant adverse events from a drug interaction between quetiapine and atazanavir-ritonavir in two patients.
McCoy, C; Pollack, TM; Stead, W, 2009
)
0.35
"The overall incidence of adverse events (AEs) was similar for quetiapine XR (69."( Safety and tolerability of once-daily extended release quetiapine fumarate in acute schizophrenia: pooled data from randomised, double-blind, placebo-controlled studies.
Brecher, M; Huizar, K; Meulien, D, 2010
)
0.36
" Safety was assessed by comparing incidence of adverse drug effects causing discontinuation of either study drug."( Prazosin versus quetiapine for nighttime posttraumatic stress disorder symptoms in veterans: an assessment of long-term comparative effectiveness and safety.
Allison, KM; Byers, MG; Lee, JK; Wendel, CS, 2010
)
0.36
"To compare the efficacy and adverse effect profiles of 2 widely used atypical antipsychotics in the short-term phase of first-episode schizophrenia in patients who were treatment-naive."( Esquire trial: efficacy and adverse effects of quetiapine versus risperidone in first-episode schizophrenia.
Craig, TK; Elanjithara, T; Gafoor, R; Landau, S; McGuire, P; Power, P, 2010
)
0.36
" Psychopathologic diagnoses and adverse effects were assessed by blinded raters at 4 weekly intervals."( Esquire trial: efficacy and adverse effects of quetiapine versus risperidone in first-episode schizophrenia.
Craig, TK; Elanjithara, T; Gafoor, R; Landau, S; McGuire, P; Power, P, 2010
)
0.36
"Both quetiapine and risperidone were associated with a reduction in immediate symptoms and relatively few adverse effects other than weight gain."( Esquire trial: efficacy and adverse effects of quetiapine versus risperidone in first-episode schizophrenia.
Craig, TK; Elanjithara, T; Gafoor, R; Landau, S; McGuire, P; Power, P, 2010
)
0.36
"Quetiapine and risperidone are both effective treatments in first-episode schizophrenia at doses lower than those used in patients with long-term schizophrenia and are similar in efficacy and the incidence of adverse effects."( Esquire trial: efficacy and adverse effects of quetiapine versus risperidone in first-episode schizophrenia.
Craig, TK; Elanjithara, T; Gafoor, R; Landau, S; McGuire, P; Power, P, 2010
)
0.36
" Safety measures included adverse event (AE) reporting and administration of the Abnormal Involuntary Movement Scale (AIMS)."( Switching from quetiapine to ziprasidone: a sixteen-week, open-label, multicenter study evaluating the effectiveness and safety of ziprasidone in outpatient subjects with schizophrenia or schizoaffective disorder.
Bachinsky, M; Cavus, I; Chappell, P; Glue, P; Karayal, ON; Kolluri, S; Stewart, M, 2011
)
0.37
" Secondary outcomes were adverse events, metabolic side effects, and symptom severity."( A randomized, double-blind, placebo-controlled study of the safety and tolerability of high-dose quetiapine in patients with persistent symptoms of schizophrenia or schizoaffective disorder.
Eriksson, H; Gendron, A; Honer, WG; Labelle, A; MacEwan, GW; Stip, E; Williams, R, 2012
)
0.38
" Both doses of quetiapine were safe and well tolerated."( A randomized, double-blind, placebo-controlled study of the safety and tolerability of high-dose quetiapine in patients with persistent symptoms of schizophrenia or schizoaffective disorder.
Eriksson, H; Gendron, A; Honer, WG; Labelle, A; MacEwan, GW; Stip, E; Williams, R, 2012
)
0.38
" Based on adverse drug reaction (ADR) reports of QT prolongation and torsades de pointes, regulatory agencies recommended the use of continuous telemetry or advising against the intravenous administration in general."( Comparative safety of antipsychotics in the WHO pharmacovigilance database: the haloperidol case.
Guglielmo, BJ; Meier, CR; Meyer-Massetti, C; Rätz Bravo, AE; Vaerini, S, 2011
)
0.37
"While regulatory agencies advise against the use of intravenous haloperidol, review of VigiBase does not reveal that the intravenous route is any more likely to be associated with cardiac adverse events."( Comparative safety of antipsychotics in the WHO pharmacovigilance database: the haloperidol case.
Guglielmo, BJ; Meier, CR; Meyer-Massetti, C; Rätz Bravo, AE; Vaerini, S, 2011
)
0.37
" Several case reports on adverse effects with low doses of the drug were also included."( Safety of low doses of quetiapine when used for insomnia.
Coe, HV; Hong, IS, 2012
)
0.38
" At recommended doses, atypical antipsychotics such as quetiapine are associated with metabolic adverse events (diabetes, obesity, hyperlipidemia)."( Safety of low doses of quetiapine when used for insomnia.
Coe, HV; Hong, IS, 2012
)
0.38
" The most common treatment-related adverse events in the group receiving quetiapine XR were sedation (10."( Safety of quetiapine fumarate extended release in the treatment of Korean patients with acute schizophrenia.
Kim, CE; Kim, CY; Kim, YH; Kim, YT; Lee, JG; Lee, JI; Yoo, SY; Yoon, JS, 2012
)
0.38
"Atypical antipsychotic agents have been associated with cerebrovascular adverse events, particularly in elderly dementia patients."( Comparative risk of cerebrovascular adverse events in community-dwelling older adults using risperidone, olanzapine and quetiapine: a multiple propensity score-adjusted retrospective cohort study.
Aparasu, RR; Chatterjee, S; Chen, H; Johnson, ML, 2012
)
0.38
"16) was associated with a decrease in the risk of cerebrovascular adverse events compared with olanzapine."( Comparative risk of cerebrovascular adverse events in community-dwelling older adults using risperidone, olanzapine and quetiapine: a multiple propensity score-adjusted retrospective cohort study.
Aparasu, RR; Chatterjee, S; Chen, H; Johnson, ML, 2012
)
0.38
" Prescribers should closely monitor the patients treated with atypical agents for the incidence of cerebrovascular adverse events."( Comparative risk of cerebrovascular adverse events in community-dwelling older adults using risperidone, olanzapine and quetiapine: a multiple propensity score-adjusted retrospective cohort study.
Aparasu, RR; Chatterjee, S; Chen, H; Johnson, ML, 2012
)
0.38
" Safety endpoints included adverse events and assessments of clinical chemistry values, suicidality, and extrapyramidal symptoms."( Efficacy and safety of quetiapine in adolescents with schizophrenia investigated in a 6-week, double-blind, placebo-controlled trial.
Earley, WR; Findling, RL; McKenna, K; Pathak, S; Stankowski, J, 2012
)
0.38
" Adverse events associated with quetiapine were mostly mild to moderate in intensity and were consistent with its known profile in adults with schizophrenia."( Efficacy and safety of quetiapine in adolescents with schizophrenia investigated in a 6-week, double-blind, placebo-controlled trial.
Earley, WR; Findling, RL; McKenna, K; Pathak, S; Stankowski, J, 2012
)
0.38
"Primary metabolic markers (body mass index, blood pressure, fasting blood glucose, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, and triglycerides), percentage of patients who stay on the randomly assigned atypical antipsychotic for at least 6 months, psychopathology, percentage of patients who develop metabolic syndrome, and percentage of patients who develop serious and nonserious adverse events."( Comparison of longer-term safety and effectiveness of 4 atypical antipsychotics in patients over age 40: a trial using equipoise-stratified randomization.
Arndt, S; Glorioso, DK; Golshan, S; Henry, R; Jeste, DV; Jin, H; Kraemer, HC; Mudaliar, S; Shih, PA, 2013
)
0.39
"Because of a high incidence of serious adverse events, quetiapine was discontinued midway through the trial."( Comparison of longer-term safety and effectiveness of 4 atypical antipsychotics in patients over age 40: a trial using equipoise-stratified randomization.
Arndt, S; Glorioso, DK; Golshan, S; Henry, R; Jeste, DV; Jin, H; Kraemer, HC; Mudaliar, S; Shih, PA, 2013
)
0.39
"Lurasidone 80 mg and 160 mg doses administered once-daily in the evening, were safe and effective treatments for subjects with acute schizophrenia, with increased response rates observed at the higher dose."( Efficacy and safety of lurasidone 80 mg/day and 160 mg/day in the treatment of schizophrenia: a randomized, double-blind, placebo- and active-controlled trial.
Cucchiaro, J; Hsu, C; Kalali, AH; Loebel, A; Pikalov, A; Potkin, SG; Sarma, K; Xu, L, 2013
)
0.39
" Adverse events associated with quetiapine were mostly mild to moderate in intensity."( Efficacy and safety of quetiapine in children and adolescents with mania associated with bipolar I disorder: a 3-week, double-blind, placebo-controlled trial.
Acevedo, LD; Delbello, MP; Earley, WR; Findling, RL; Pathak, S; Stankowski, J, 2013
)
0.39
" Treatment was generally well tolerated and adverse events were broadly consistent with the known profile of quetiapine in adults with bipolar disorder."( Efficacy and safety of quetiapine in children and adolescents with mania associated with bipolar I disorder: a 3-week, double-blind, placebo-controlled trial.
Acevedo, LD; Delbello, MP; Earley, WR; Findling, RL; Pathak, S; Stankowski, J, 2013
)
0.39
" Safety and tolerability outcomes assessed from open-label baseline to week 26 included adverse events (AEs), metabolic/laboratory parameters, extrapyramidal symptoms, suicidality, and vital signs."( Safety, tolerability, and efficacy of quetiapine in youth with schizophrenia or bipolar I disorder: a 26-week, open-label, continuation study.
DelBello, M; Earley, WR; Findling, RL; Liu, S; Pathak, S, 2013
)
0.39
"In this 26-week study, quetiapine flexibly dosed at 400-800 mg/day, with options to reduce dosing based on tolerability, was generally safe and well tolerated in youth."( Safety, tolerability, and efficacy of quetiapine in youth with schizophrenia or bipolar I disorder: a 26-week, open-label, continuation study.
DelBello, M; Earley, WR; Findling, RL; Liu, S; Pathak, S, 2013
)
0.39
" The safety was evaluated by the Udvalg Kliniske Undersogelser side effect rating scale."( Efficacy and safety of haloperidol versus atypical antipsychotic medications in the treatment of delirium.
Choi, SH; Choi, WJ; Kim, JJ; Park, JY; Park, KM; Seok, JH; Yoon, HJ, 2013
)
0.39
" Fifteen subjects experienced a few adverse events, but there were no significant differences in adverse event profiles among the four groups."( Efficacy and safety of haloperidol versus atypical antipsychotic medications in the treatment of delirium.
Choi, SH; Choi, WJ; Kim, JJ; Park, JY; Park, KM; Seok, JH; Yoon, HJ, 2013
)
0.39
"Haloperidol, risperidone, olanzapine, and quetiapine were equally efficacious and safe in the treatment of delirium."( Efficacy and safety of haloperidol versus atypical antipsychotic medications in the treatment of delirium.
Choi, SH; Choi, WJ; Kim, JJ; Park, JY; Park, KM; Seok, JH; Yoon, HJ, 2013
)
0.39
" Quetiapine XR was generally safe and well tolerated."( Efficacy and safety of extended-release quetiapine fumarate in youth with bipolar depression: an 8 week, double-blind, placebo-controlled trial.
DelBello, MP; Earley, WR; Findling, RL; Liu, S; Pathak, S, 2014
)
0.4
" The aim of this study was to identify genetic markers related to the pharmacokinetics, pharmacodynamics, and adverse effects of quetiapine."( Pharmacogenetics of quetiapine in healthy volunteers: association with pharmacokinetics, pharmacodynamics, and adverse effects.
Abad-Santos, F; Borobia, A; Cabaleiro, T; Carcas, A; López-Rodríguez, R; Novalbos, J; Ochoa, D; Román, M, 2015
)
0.42
"The reports submitted to the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) from 1997 to 2011 were reviewed to assess serious adverse events induced by the administration of antipsychotics to children."( Antipsychotics-associated serious adverse events in children: an analysis of the FAERS database.
Brown, JB; Kadoyama, K; Kimura, G; Miki, I; Nakamura, T; Nisiguchi, K; Okuno, Y; Sakaeda, T, 2015
)
0.42
" Signals in the data that signified a drug-associated adverse event were detected via quantitative data mining algorithms."( Antipsychotics-associated serious adverse events in children: an analysis of the FAERS database.
Brown, JB; Kadoyama, K; Kimura, G; Miki, I; Nakamura, T; Nisiguchi, K; Okuno, Y; Sakaeda, T, 2015
)
0.42
" Significant signals of the QT prolongation adverse event were detected only for ziprasidone and risperidone."( Antipsychotics-associated serious adverse events in children: an analysis of the FAERS database.
Brown, JB; Kadoyama, K; Kimura, G; Miki, I; Nakamura, T; Nisiguchi, K; Okuno, Y; Sakaeda, T, 2015
)
0.42
"It was suggested that there is a level of diversity in the strength of the association between various first- and second-generation antipsychotics with associated serious adverse events, which possibly lead to fatal outcomes."( Antipsychotics-associated serious adverse events in children: an analysis of the FAERS database.
Brown, JB; Kadoyama, K; Kimura, G; Miki, I; Nakamura, T; Nisiguchi, K; Okuno, Y; Sakaeda, T, 2015
)
0.42
"7%) experienced adverse events including headache, exacerbation of psychosis and dysuria."( The efficacy and safety of once-daily quetiapine extended release in patients with schizophrenia switched from other antipsychotics: an open-label study in Chinese population.
Lee, MS; Pan, PY; Yeh, CB, 2015
)
0.42
" Safety measures included body mass index, serum prolactin, extrapyramidal adverse effects, and electrocardiogram."( Efficacy and Safety of Risperidone and Quetiapine in Adolescents With Bipolar II Disorder Comorbid With Conduct Disorder.
Masi, G; Milone, A; Pisano, S; Stawinoga, A; Veltri, S, 2015
)
0.42
" EPS were assessed at baseline and 4, 8, and 12 weeks after naturalistic SGA initiation for schizophrenia, mood, disruptive behavior, and autism spectrum disorders using the Simpson-Angus Scale (SAS), Barnes Akathisia Scale, Abnormal Involuntary Movement Scale (AIMS), and Treatment Emergent Side Effect Scale."( Neuromotor Adverse Effects in 342 Youth During 12 Weeks of Naturalistic Treatment With 5 Second-Generation Antipsychotics.
Al-Jadiri, A; Azzo, S; Carbon, M; Correll, CU; Kane, JM; Kapoor, S; Saito, E; Sarkaria, T; Sheridan, E, 2015
)
0.42
"In this population of critically ill youth, short-term use of quetiapine as treatment for delirium appears to be safe, without serious adverse events."( Evaluation of the Safety of Quetiapine in Treating Delirium in Critically Ill Children: A Retrospective Review.
Greenwald, BM; Herrup, E; Joyce, C; Kaur, S; Mendez-Rico, E; Silver, G; Traube, C; Witcher, R, 2015
)
0.42
"The aim of this study was to evaluate demographic, clinical, and treatment factors that may impact on neurological adverse effects in naive and quasi-naive children and adolescents treated with antipsychotics."( Neurological Adverse Effects of Antipsychotics in Children and Adolescents.
Alda, JA; Andrés Nestares, P; Arango, C; Baeza, I; Cantarero, CM; Castro-Fornieles, J; de la Serna, E; Garcia-Amador, M; Merchán-Naranjo, J; Moreno, C; Muñoz, D; Tapia, C, 2015
)
0.42
" Total dyskinesia score (DyskinesiaS) and total Parkinson score (ParkinsonS) were calculated from the Maryland Psychiatric Research Center Involuntary Movement Scale, total UKU-Cognition score was calculated from the UKU Side Effect Rating Scale."( Neurological Adverse Effects of Antipsychotics in Children and Adolescents.
Alda, JA; Andrés Nestares, P; Arango, C; Baeza, I; Cantarero, CM; Castro-Fornieles, J; de la Serna, E; Garcia-Amador, M; Merchán-Naranjo, J; Moreno, C; Muñoz, D; Tapia, C, 2015
)
0.42
"Antipsychotics increased neurological adverse effects in a naive and quasi-naive pediatric population and should be carefully monitored."( Neurological Adverse Effects of Antipsychotics in Children and Adolescents.
Alda, JA; Andrés Nestares, P; Arango, C; Baeza, I; Cantarero, CM; Castro-Fornieles, J; de la Serna, E; Garcia-Amador, M; Merchán-Naranjo, J; Moreno, C; Muñoz, D; Tapia, C, 2015
)
0.42
" The aim of this paper was to review and describe adverse drug events associated with quetiapine use in older adults."( Quetiapine safety in older adults: a systematic literature review.
El-Saifi, N; Jones, C; Moyle, W; Tuffaha, H, 2016
)
0.43
" The most commonly reported adverse events were somnolence (25-39%), dizziness (15-27%), headache (10-23%), postural hypotension (6-18%) and weight gain (11-30%)."( Quetiapine safety in older adults: a systematic literature review.
El-Saifi, N; Jones, C; Moyle, W; Tuffaha, H, 2016
)
0.43
" Adverse events occurred in 96 patients (65."( Efficacy and safety of quetiapine extended release monotherapy in bipolar depression: a multi-center, randomized, double-blind, placebo-controlled trial.
Gao, C; Gu, N; Li, H; Li, K; Li, L; Lu, Z; Ning, Y; Shi, J; Tan, Q; Tian, H; Wang, G; Wang, X; Xie, S; Xu, X; Xu, Y; Yang, F; Yu, X; Zhang, H; Zhang, K, 2016
)
0.43
" Quetiapine XR was generally safe and well tolerated (ClinicalTrials."( Efficacy and safety of quetiapine extended release monotherapy in bipolar depression: a multi-center, randomized, double-blind, placebo-controlled trial.
Gao, C; Gu, N; Li, H; Li, K; Li, L; Lu, Z; Ning, Y; Shi, J; Tan, Q; Tian, H; Wang, G; Wang, X; Xie, S; Xu, X; Xu, Y; Yang, F; Yu, X; Zhang, H; Zhang, K, 2016
)
0.43
" Although knowledge of adverse drug reactions in children and adolescents is scarce, quetiapine is increasingly being used for youth in Denmark."( Adverse events in children and adolescents treated with quetiapine: an analysis of adverse drug reaction reports from the Danish Medicines Agency database.
Bruhn, CH; Fink-Jensen, A; Hashemi, N; Jakobsen, KD; Nielsen, J; Pagsberg, AK; Wallach-Kildemoes, H, 2017
)
0.46
" Safety objectives included adverse event (AE) monitoring, laboratory test results, and electrocardiograms."( A 6-week, multicenter, double-blind, double-dummy, chlorpromazine-controlled non-inferiorityrandomized phase iiitrial to evaluate the efficacy and safety of quetiapine fumarate (SEROQUEL) extended-release (XR) in the treatment of patients with schizophren
Gu, N; Li, H; Li, K; Ma, C; Shen, Y; Shi, J; Wang, G; Wang, X; Xie, S; Xu, X; Zhang, H, 2018
)
0.48
" The most frequent treatment-emergent adverse events in patients receiving brexpiprazole were akathisia (6."( Efficacy and safety of flexibly dosed brexpiprazole for the adjunctive treatment of major depressive disorder: a randomized, active-referenced, placebo-controlled study.
Augustine, C; Brewer, C; Hefting, N; Hobart, M; Josiassen, MK; McQuade, RD; Sanchez, R; Skuban, A; Zhang, P, 2018
)
0.48
" The use of antipsychotics is associated with a number of adverse effects for which routine monitoring is recommended."( Antipsychotic Prescribing and Safety Monitoring Practices in Children and Youth: A Population-Based Study in Alberta, Canada.
Cepoiu-Martin, M; Chen, W; Cooke, L; Duncan, D; Pringsheim, T; Stang, A; Symonds, C, 2018
)
0.48
"We examined systematic adverse events (AEs) in Part 1 (of 2) of a study describing the assessment and reporting of AEs in clinical trials."( Harms are assessed inconsistently and reported inadequately part 1: systematic adverse events.
Canner, JK; Dickersin, K; Fusco, N; Hong, H; Li, T; Mayo-Wilson, E, 2019
)
0.51
"We examined nonsystematic adverse events (AEs) in Part 2 (of 2) of a study describing the assessment and reporting AEs in clinical trials."( Harms are assessed inconsistently and reported inadequately Part 2: nonsystematic adverse events.
Canner, JK; Dickersin, K; Fusco, N; Hong, H; Li, T; Mayo-Wilson, E, 2019
)
0.51
" Different methods for reporting adverse events across trials or across sources for a single trial may produce inconsistent information about the adverse events associated with interventions."( Opportunities for selective reporting of harms in randomized clinical trials: Selection criteria for non-systematic adverse events.
Canner, JK; Dickersin, K; Fusco, N; Hong, H; Li, T; Mayo-Wilson, E, 2019
)
0.51
" The effect size, remission/response rate, and risk for discontinuation due to adverse events (AEs), weight gain (WG), nervous systems and gastrointestinal AEs were assessed and compared between two regions with Cohen's d or number needed to treat/harm."( Do Asian and North American patients with bipolar disorder have similar efficacy, tolerability, and safety profile during clinical trials with atypical antipsychotics?
Bai, Y; Chen, G; Gao, K; Yang, H, 2020
)
0.56
" Adverse events over 7 days were evaluated."( Safety and effectiveness of antipsychotic medication for delirium in patients with advanced cancer: A large-scale multicenter prospective observational study in real-world palliative care settings.
Akechi, T; Imai, K; Iwase, S; Maeda, I; Matsumoto, Y; Morita, T; Nakahara, R; Ogawa, A; Oyamada, S; Sakashita, A; Uemura, K; Yamaguchi, T; Yoshiuchi, K,
)
0.13
"5%) were the most prevalent adverse events."( Safety and effectiveness of antipsychotic medication for delirium in patients with advanced cancer: A large-scale multicenter prospective observational study in real-world palliative care settings.
Akechi, T; Imai, K; Iwase, S; Maeda, I; Matsumoto, Y; Morita, T; Nakahara, R; Ogawa, A; Oyamada, S; Sakashita, A; Uemura, K; Yamaguchi, T; Yoshiuchi, K,
)
0.13
"The use of antipsychotics as part of comprehensive delirium management was safe and may provide some symptomatic benefits for patients with terminal illness and delirium."( Safety and effectiveness of antipsychotic medication for delirium in patients with advanced cancer: A large-scale multicenter prospective observational study in real-world palliative care settings.
Akechi, T; Imai, K; Iwase, S; Maeda, I; Matsumoto, Y; Morita, T; Nakahara, R; Ogawa, A; Oyamada, S; Sakashita, A; Uemura, K; Yamaguchi, T; Yoshiuchi, K,
)
0.13
" Neonatal providers should be aware of maternal medications and prepare for possible adverse effects, particularly from common psychotropic exposures."( Why the Maternal Medication List Matters: Neonatal Toxicity From Combined Serotonergic Exposures.
Brajcich, MR; Marks, J; Messer, RD; Murphy, ME; Palau, MA, 2021
)
0.62
" Available safety outcomes included discontinuations (all-cause, lack of efficacy, adverse events), metabolic parameters (weight change, cholesterol, triglycerides, glucose), changes in prolactin, and somnolence."( Systematic Review and Network Meta-analysis: Efficacy and Safety of Second-Generation Antipsychotics in Youths With Bipolar Depression.
DelBello, MP; Hagi, K; Heller, V; Kadakia, A; Loebel, A; Nosaka, T; Singh, R, 2022
)
0.72
" SGAs used for approved indications are associated with significant metabolic adverse effects, including weight gain."( Metabolic adverse effects of off-label use of second-generation antipsychotics in the adult population: a systematic review and meta-analysis.
Agarwal, SM; Asgariroozbehani, R; Bowden, S; Hahn, MK; McIntyre, WB; Remington, G; Siskind, D; Smith, E; Stogios, N; Tran, V, 2022
)
0.72
" Patients treated with these agents may be at higher risk for adverse events such as QTc prolongation and arrhythmias."( Atypical Antipsychotic Safety in the CICU.
Abdul-Aziz, AA; Adie, SK; Deshmukh, A; Gondi, K; Hanna, MP; Ketcham, SW; Konerman, MC; Prescott, HC; Thomas, MP, 2022
)
0.72
" Finally, there was no significant difference in the frequency of adverse events."( Levetiracetam adjunct to quetiapine for the acute manic phase of bipolar disorder: a randomized, double-blind and placebo-controlled clinical trial of efficacy, safety and tolerability.
Akhondzadeh, S; Arbabi, M; Hasanzadeh, A; Naderi, S; Ostadpour, M; Samsami, FS; Shamabadi, A; Zarezadeh, F, 2022
)
0.72
" Secondary outcomes included psychopathology, remission, all-cause-discontinuation, inefficacy-related discontinuation, and adverse events."( Efficacy and safety/tolerability of antipsychotics in the treatment of adult patients with major depressive disorder: a systematic review and meta-analysis.
Correll, CU; Hagi, K; Kane, JM; Kishimoto, T; Kurokawa, S, 2023
)
0.91
"Retrospective studies using spontaneous reporting system databases have provided a great understanding of adverse drug reactions (ADRs) in the real world, complementing the data obtained from randomized controlled trials."( Characteristics of adverse reactions among antipsychotic drugs using the Korean Adverse Event Reporting System database from 2010 to 2019.
Byeon, SJ; Chung, SJ; Oh, S, 2022
)
0.72
"Data were collected from the Korea Adverse Event Reporting System database between 2010 and 2019."( Characteristics of adverse reactions among antipsychotic drugs using the Korean Adverse Event Reporting System database from 2010 to 2019.
Byeon, SJ; Chung, SJ; Oh, S, 2022
)
0.72
"In total, 5067 adverse events associated with antipsychotic drugs were reported."( Characteristics of adverse reactions among antipsychotic drugs using the Korean Adverse Event Reporting System database from 2010 to 2019.
Byeon, SJ; Chung, SJ; Oh, S, 2022
)
0.72
"5 mg/day) treatment during the first hospitalization did not cause any side effects, but treatment with mirtazapine (15 mg/day) and venlafaxine (150 mg/day) during the second hospitalization caused clonus and disturbance of consciousness, and these adverse effects resulted in a prolonged period of hospitalization."( A case of mood disorder with severe side effects of antidepressants in association with resistance to thyroid hormone beta with a THRB mutation.
Hasegawa, C; Komahashi-Sasaki, H; Maehara, R; Shimoda, K; Yasui-Furukori, N, 2022
)
0.72
" The changes in the depressive rating scale, remission/response rates, nervous system adverse events (NSAEs), gastrointestinal adverse events (GIAEs), metabolic parameters, and prolactin were compared between medication and placebo or among medications with the Cohen's d or number needed to treat/harm."( Efficacy and safety profiles of mood stabilizers and antipsychotics for bipolar depression: a systematic review.
Bai, Y; Cai, L; Chen, G; Yang, H, 2023
)
0.91
" Due to the limitations of clinical trials, the association between quetiapine and rare cardiac adverse events (AEs) is still unclear."( Cardiac adverse events associated with quetiapine: Disproportionality analysis of FDA adverse event reporting system.
Ding, Y; Liu, L; Shu, Y; Zhang, Q, 2023
)
0.91
" However, it can cause mild or severe hepatic adverse events and rarely fatal liver damage."( Investigation of hepatic adverse events due to quetiapine by using the common data model.
Chang, DJ; Chang, SH; Choi, IY; Chung, YW; Kang, DY; Kim, K; Ko, S; Seo, YG, 2023
)
0.91
" We analyzed the status of quetiapine use, adverse events, and hepatic impairment."( Investigation of hepatic adverse events due to quetiapine by using the common data model.
Chang, DJ; Chang, SH; Choi, IY; Chung, YW; Kang, DY; Kim, K; Ko, S; Seo, YG, 2023
)
0.91
"The numbers of patients with non-serious and severe hepatic adverse reactions were 2566 (5."( Investigation of hepatic adverse events due to quetiapine by using the common data model.
Chang, DJ; Chang, SH; Choi, IY; Chung, YW; Kang, DY; Kim, K; Ko, S; Seo, YG, 2023
)
0.91
"Our findings suggest that quetiapine should be cautiously used, and hepatic function should be monitored in patients using quetiapine because it can cause mild or severe hepatic adverse events, complications, and in rare cases, fatal liver damage."( Investigation of hepatic adverse events due to quetiapine by using the common data model.
Chang, DJ; Chang, SH; Choi, IY; Chung, YW; Kang, DY; Kim, K; Ko, S; Seo, YG, 2023
)
0.91
"To compare the risk for in-hospital adverse events associated with oral haloperidol, olanzapine, quetiapine, and risperidone in older patients after major surgery."( Comparative Safety Analysis of Oral Antipsychotics for In-Hospital Adverse Clinical Events in Older Adults After Major Surgery : A Nationwide Cohort Study.
Bateman, BT; Ely, EW; Inouye, SK; Jones, RN; Kim, DH; Lee, SB; Levin, R; Marcantonio, ER; Metzger, E; Pandharipande, PP; Park, CM; Pisani, MA, 2023
)
0.91
"These results suggest that atypical antipsychotics and haloperidol have similar rates of in-hospital adverse clinical events in older patients with postoperative delirium who receive an oral low-to-moderate dose antipsychotic drug."( Comparative Safety Analysis of Oral Antipsychotics for In-Hospital Adverse Clinical Events in Older Adults After Major Surgery : A Nationwide Cohort Study.
Bateman, BT; Ely, EW; Inouye, SK; Jones, RN; Kim, DH; Lee, SB; Levin, R; Marcantonio, ER; Metzger, E; Pandharipande, PP; Park, CM; Pisani, MA, 2023
)
0.91

Pharmacokinetics

Quetiapine fumarate XR has a dose-proportional pharmacokinetic profile at doses ranging from 300 to 800 mg once daily, and a slower time to reach C max and steady state after 3 days of sequential dosing.

ExcerptReferenceRelevance
" The present assay method was used to support a study comparing the pharmacokinetic profile of quetiapine with the time course of dopamine D2 and serotonin 5-HT2 receptor occupancy in the brain using positron emission tomography (PET)."( Analysis and pharmacokinetics of quetiapine and two metabolites in human plasma using reversed-phase HPLC with ultraviolet and electrochemical detection.
Davis, PC; Gefvert, O; Wong, J, 1999
)
0.3
" Key assessments were pharmacokinetic analysis of plasma quetiapine concentrations and neurologic, safety, and efficacy evaluations."( Pharmacokinetics, tolerability, and clinical effectiveness of quetiapine fumarate: an open-label trial in adolescents with psychotic disorders.
Arvanitis, LA; Brown, KL; Chaney, RO; Foster, KD; Friedman, LM; Heubi, JE; McConville, BJ; Sorter, MT; Thyrum, PT; Wilkinson, LA; Yeh, C, 2000
)
0.31
" Decline in serum quetiapine concentration followed a biexponential pattern with a terminal elimination half-life of 22 hours."( Quetiapine fumarate overdose: clinical and pharmacokinetic lessons from extreme conditions.
Pollak, PT; Zbuk, K, 2000
)
0.31
" Elevated serum concentrations associated with this overdose remained above the limit of detection long enough to document a terminal elimination half-life of 22 hours in this patient."( Quetiapine fumarate overdose: clinical and pharmacokinetic lessons from extreme conditions.
Pollak, PT; Zbuk, K, 2000
)
0.31
" No clinically significant differences were found when the pharmacokinetic parameters for subjects with renal or hepatic impairment were compared with those for healthy control subjects."( Single-dose pharmacokinetics of quetiapine in subjects with renal or hepatic impairment.
Thyrum, PT; Wong, YW; Yeh, C, 2000
)
0.31
" The time course of quetiapine concentrations was described by use of a one-compartment open linear pharmacokinetic model with first-order absorption and elimination."( Prediction of the outcome of a phase 3 clinical trial of an antischizophrenic agent (quetiapine fumarate) by simulation with a population pharmacokinetic and pharmacodynamic model.
Holford, NH; Kimko, HC; Peck, CC; Reele, SS, 2000
)
0.31
" In pharmacokinetic studies in humans, quetiapine was rapidly absorbed after oral administration, with median time to reach maximum observed plasma concentration ranging from 1 to 2 hours."( Clinical pharmacokinetics of quetiapine: an atypical antipsychotic.
DeVane, CL; Nemeroff, CB, 2001
)
0.31
" Key assessments included pharmacokinetic analysis of quetiapine, the Udvalg for kliniske undersøgelser (UKU) Side Effect Rating Scale, and safety evaluations (e."( Effect of fluoxetine and imipramine on the pharmacokinetics and tolerability of the antipsychotic quetiapine.
Alva, G; Arvanitis, LA; Carreon, D; Kalali, A; Potkin, SG; Thyrum, PT; Yeh, C, 2002
)
0.31
" Quetiapine plasma concentrations were measured before and after cimetidine coadministration, and quetiapine pharmacokinetic parameters were calculated."( The effect of multiple doses of cimetidine on the steady-state pharmacokinetics of quetiapine in men with selected psychotic disorders.
Keck, PE; Strakowski, SM; Thyrum, PT; Wong, YW; Yeh, C, 2002
)
0.31
" In humans, quetiapine exhibits linear pharmacokinetics with a mean terminal half-life of 7 hours."( Quetiapine: preclinical studies, pharmacokinetics, drug interactions, and dosing.
Goldstein, J; Kinkead, B; Nemeroff, CB, 2002
)
0.31
" Descriptive statistics summarised plasma quetiapine concentrations and pharmacokinetic parameters by trial day."( Pharmacokinetics of quetiapine in elderly patients with selected psychotic disorders.
Arvanitis, LA; Fuller, MA; Jaskiw, GE; Thyrum, PT; Yeh, C, 2004
)
0.32
" The apparent oral clearance, volume of distribution and half-life did not change as a function of dose."( Pharmacokinetics of quetiapine in elderly patients with selected psychotic disorders.
Arvanitis, LA; Fuller, MA; Jaskiw, GE; Thyrum, PT; Yeh, C, 2004
)
0.32
" Individual pharmacokinetic parameter values were calculated using a one-compartment open model and a Bayesian fitting procedure."( Quetiapine in overdosage: a clinical and pharmacokinetic analysis of 14 cases.
Boswijk, DJ; de Haas, JA; Hunfeld, NG; Touw, DJ; van Putten, MJ; Westerman, EM, 2006
)
0.33
" A fully Bayesian methodology for population pharmacokinetic analysis was used and data were modelled using WinBUGS."( Pharmacokinetics of quetiapine in overdose and the effect of activated charcoal.
Duffull, SB; Friberg, LE; Hackett, LP; Isbister, GK, 2007
)
0.34
"To determine whether there is a pharmacokinetic drug interaction between quetiapine fumarate and divalproex sodium."( Open-label steady-state pharmacokinetic drug interaction study on co-administered quetiapine fumarate and divalproex sodium in patients with schizophrenia, schizoaffective disorder, or bipolar disorder.
Davis, PC; DeVane, CL; Ennis, DJ; Figueroa, C; Hamer-Maansson, JE; Smith, MA; Winter, HR, 2007
)
0.34
"Combination therapy with quetiapine (150 mg bid) and divalproex (500 mg bid) resulted in small and statistically non-significant pharmacokinetic changes."( Open-label steady-state pharmacokinetic drug interaction study on co-administered quetiapine fumarate and divalproex sodium in patients with schizophrenia, schizoaffective disorder, or bipolar disorder.
Davis, PC; DeVane, CL; Ennis, DJ; Figueroa, C; Hamer-Maansson, JE; Smith, MA; Winter, HR, 2007
)
0.34
"This 10-day, single-center, open-label, randomized, crossover study compared pharmacokinetic profiles and tolerability of extended release quetiapine fumarate (quetiapine XR) with quetiapine immediate release (quetiapine IR) in patients with schizophrenia, schizoaffective disorder or bipolar disorder."( Pharmacokinetic profiles of extended release quetiapine fumarate compared with quetiapine immediate release.
Brecher, M; Figueroa, C; Hamer-Maansson, JE; Winter, H, 2009
)
0.35
" The antidepressive response is considered to be mediated by the metabolite N-desalkylquetiapine, and the aim of this study was to assess the interindividual pharmacokinetic variability of quetiapine and N-desalkylquetiapine in psychiatric patients based on therapeutic drug monitoring samples."( Pharmacokinetic variability of quetiapine and the active metabolite N-desalkylquetiapine in psychiatric patients.
Bakken, GV; Hermann, M; Molden, E; Refsum, H; Rudberg, I, 2011
)
0.37
" Pharmacokinetic variability was expressed as the 5-95 percentile range in dose-adjusted serum concentrations (C/D ratios)."( Pharmacokinetic variability of quetiapine and the active metabolite N-desalkylquetiapine in psychiatric patients.
Bakken, GV; Hermann, M; Molden, E; Refsum, H; Rudberg, I, 2011
)
0.37
"The pharmacokinetic variability was greater for quetiapine compared with N-desalkylquetiapine."( Pharmacokinetic variability of quetiapine and the active metabolite N-desalkylquetiapine in psychiatric patients.
Bakken, GV; Hermann, M; Molden, E; Refsum, H; Rudberg, I, 2011
)
0.37
" The method is proved to be accurate and specific, and was applied to the pharmacokinetic study in healthy Chinese volunteers."( Validated LC-MS-MS method for the determination of quetiapine in human plasma: application to a pharmacokinetic study.
Kuo, BP; Pan, RN; Pao, LH, 2012
)
0.38
" Compared with fasting, a high-fat meal increased the AUC and Cmax for quetiapine XR, whereas a light meal had no significant effect on these parameters."( Pharmacokinetic profile of the extended-release formulation of quetiapine fumarate (quetiapine XR): clinical implications.
Bui, K; Earley, W; Nyberg, S, 2013
)
0.39
"At steady state, quetiapine XR provided a similar AUC and Cmin and a slightly lower Cmax relative to an equivalent dose of quetiapine IR administered twice daily."( Pharmacokinetic profile of the extended-release formulation of quetiapine fumarate (quetiapine XR): clinical implications.
Bui, K; Earley, W; Nyberg, S, 2013
)
0.39
" A linear mixed model was performed to compare pharmacokinetic parameters."( MDR-1 genotypes and quetiapine pharmacokinetics in healthy volunteers.
Dorado, P; Estévez-Carrizo, FE; Fariñas, H; González-Vacarezza, N; Llerena, A; Peñas-Lledó, EM, 2013
)
0.39
" The present study aims to improve our understanding of antipsychotic-related adverse reactions (ARs) and their possible association with common genetic variants of pharmacodynamic proteins such as neurotransmitter receptors/transporters."( Pharmacodynamic genetic variants related to antipsychotic adverse reactions in healthy volunteers.
Abad-Santos, F; Ayuso, C; Borobia, AM; Cabaleiro, T; Carcas, AJ; López-Rodríguez, R; Novalbos, J; Ochoa, D; Román, M, 2013
)
0.39
"Genetic variants in pharmacodynamic genes could represent valuable markers of AR risk and antipsychotic safety."( Pharmacodynamic genetic variants related to antipsychotic adverse reactions in healthy volunteers.
Abad-Santos, F; Ayuso, C; Borobia, AM; Cabaleiro, T; Carcas, AJ; López-Rodríguez, R; Novalbos, J; Ochoa, D; Román, M, 2013
)
0.39
" After a single dose of 100 mg quetiapine was administered, plasma concentrations of quetiapine were measured for 24 h and pharmacokinetic analysis was carried out."( Influence of ABCB1 and CYP3A5 genetic polymorphisms on the pharmacokinetics of quetiapine in healthy volunteers.
Joo, HJ; Kim, KA; Lee, HM; Park, JY, 2014
)
0.4
"3435C>>T did not affect plasma levels of quetiapine, and its pharmacokinetic parameters did not differ among ABCB1 genotype groups."( Influence of ABCB1 and CYP3A5 genetic polymorphisms on the pharmacokinetics of quetiapine in healthy volunteers.
Joo, HJ; Kim, KA; Lee, HM; Park, JY, 2014
)
0.4
" Pharmacokinetic parameters for both quetiapine and N-desalkyl quetiapine (norquetiapine) were determined."( Pharmacokinetics and tolerability of extended-release quetiapine fumarate in Han Chinese patients with schizophrenia.
Chen, JX; Li, Q; Liu, Y; Si, TM; Su, YA; Tan, YL; Yang, FD, 2014
)
0.4
" The geometric mean elimination half-life (t ½) of both quetiapine and N-desalkyl quetiapine was consistent for the three dosing groups (approximately 7 h for quetiapine and approximately 18 h for N-desalkyl quetiapine)."( Pharmacokinetics and tolerability of extended-release quetiapine fumarate in Han Chinese patients with schizophrenia.
Chen, JX; Li, Q; Liu, Y; Si, TM; Su, YA; Tan, YL; Yang, FD, 2014
)
0.4
"Quetiapine fumarate XR has a dose-proportional pharmacokinetic profile at doses ranging from 300 to 800 mg once daily, and a slower time to reach C max and steady state after 3 days of sequential dosing."( Pharmacokinetics and tolerability of extended-release quetiapine fumarate in Han Chinese patients with schizophrenia.
Chen, JX; Li, Q; Liu, Y; Si, TM; Su, YA; Tan, YL; Yang, FD, 2014
)
0.4
" The purpose of the current study was to use physiologically based pharmacokinetic modeling (PBPK) quantitatively to predict the PK of the XR formulation in children and adolescents."( Development of physiologically based pharmacokinetic model to evaluate the relative systemic exposure to quetiapine after administration of IR and XR formulations to adults, children and adolescents.
Bui, KH; Johnson, TN; Zhou, D, 2014
)
0.4
" Increasing half-life was observed for QLNC in relation to free-QTP due to o significant decrease in total clearance."( Pre-clinical investigation of the modulation of quetiapine plasma pharmacokinetics and tissues biodistribution by lipid-core nanocapsules.
Carreño, F; Dalla Costa, T; Guterres, SS; Paese, K; Silva, CM, 2016
)
0.43
"We conducted a single-dose open-label crossover pharmacokinetic study in 10 healthy adults to determine whether quetiapine compounded as a rectal suppository or a topical cream achieved absorption similar to that achieved by a commercially available oral formulation."( A Single-Dose Crossover Pharmacokinetic Comparison Study of Oral, Rectal and Topical Quetiapine in Healthy Adults.
Bobo, WV; Cunningham, JL; Dierkhising, RA; Kung, S; Lapid, MI; Leung, JG; Nelson, S; Plevak, MF; Thompson, VH, 2016
)
0.43
" The aim of this work was to develop a physiologically based pharmacokinetic (PBPK)/pharmacodynamic (PD) model to predict changes in the PK parameters associated with genetic polymorphisms and the impact of these changes on drugs' PD effect."( Development of a Physiologically Based Pharmacokinetic/Pharmacodynamic Model to Predict the Impact of Genetic Polymorphisms on the Pharmacokinetics and Pharmacodynamics Represented by Receptor/Transporter Occupancy of Central Nervous System Drugs.
Alqahtani, S; Kaddoumi, A, 2016
)
0.43
" Pharmacokinetic data from a randomized crossover study evaluating 2 quetiapine 25 mg immediate-release tablets after single oral dose were used to develop a population pharmacokinetic model."( Quantitation of the impact of CYP3A5 A6986G polymorphism on quetiapine pharmacokinetics by simulation of target attainment.
Derendorf, H; Melhem, M; Shilbayeh, SA; Sy, SK; Zmeili, R, 2015
)
0.42
"The objectives of this study were to evaluate the bioequivalence of Quesero extended release (Quesero XR) tablets and Seroquel extended release (Seroquel XR) tablets under fasting and fed conditions and to determine the effect of food on the pharmacokinetic (PK) properties of Quesero XR or Seroquel XR in Chinese healthy volunteers."( Bioequivalence of two quetiapine extended release tablets in Chinese healthy volunteers under fasting and fed conditions and effects of food on pharmacokinetic profiles.
He, C; Huang, X; Liu, L; Ma, Y; Mei, H; Tian, R; Yang, H; Zhang, B; Zhang, S, 2019
)
0.51
" This study applied pharmacokinetic modelling principles to investigate the mechanism of these changes and to propose new dosing strategies to counteract these changes."( Quetiapine dose optimisation during gestation: a pharmacokinetic modelling study.
Badhan, RKS; Macfarlane, H, 2020
)
0.56
"A pharmacokinetic modelling approach was implemented using virtual population groups."( Quetiapine dose optimisation during gestation: a pharmacokinetic modelling study.
Badhan, RKS; Macfarlane, H, 2020
)
0.56
" Models were verified by assessing goodness-of-fit plots and ratios of predicted-to-observed pharmacokinetic parameters."( Dose Adjustment of Quetiapine and Aripiprazole for Pregnant Women Using Physiologically Based Pharmacokinetic Modeling and Simulation.
Jiang, X; Tang, R; Tang, S; Wang, L; Xu, M; Zheng, L, 2021
)
0.62
" As such, kratom may precipitate pharmacokinetic drug interactions when co-consumed with certain medications."( A Case of Potential Pharmacokinetic Kratom-drug Interactions Resulting in Toxicity and Subsequent Treatment of Kratom Use Disorder With Buprenorphine/Naloxone.
Brogdon, HD; Burns, AG; Cox, EJ; McPhee, MM; Paine, MF,
)
0.13

Compound-Compound Interactions

ExcerptReferenceRelevance
"Quetiapine (QTP) combined with lithium (Li) or divalproex (DVP) for the treatment of mania was evaluated in 2 double-blind, placebo-controlled studies."( Quetiapine versus placebo in combination with lithium or divalproex for the treatment of bipolar mania.
Mullen, J; Paulsson, B; Vågerö, AM; Yatham, LN, 2004
)
0.32
"This 6-week, open-label, multicenter study evaluated the efficacy and safety of quetiapine in combination with citalopram in adult patients (n=25) with ICD-10/DSM-IV unipolar psychotic depression."( Quetiapine in combination with citalopram in patients with unipolar psychotic depression.
Aschauer, H; Hrubos, W; Kasper, S; Konstantinidis, A; Lehofer, M; Nirnberger, G; Windhager, E, 2007
)
0.34
"The aim of this analysis was to compare the rates of remission/euthymia in patients with bipolar mania receiving quetiapine in combination with lithium/divalproex (QTP+Li/DVP) versus placebo (PBO) in combination with Li/DVP (PBO+Li/DVP)."( Rates of remission/euthymia with quetiapine in combination with lithium/divalproex for the treatment of acute mania.
Mullen, J; Paulsson, B; Sussman, N; Vågerö, M, 2007
)
0.34
"At Days 21 and 42, quetiapine combined with Li/DVP compared to Li/DVP monotherapy yielded significant, sustained improvements in the rate of clinical remission/euthymia in patients with bipolar mania."( Rates of remission/euthymia with quetiapine in combination with lithium/divalproex for the treatment of acute mania.
Mullen, J; Paulsson, B; Sussman, N; Vågerö, M, 2007
)
0.34
" Variables included in the analysis were age, gender, and concomitant treatment with a total of 41 drugs most often used in combination with quetiapine."( Quetiapine and drug interactions: evidence from a routine therapeutic drug monitoring service.
Castberg, I; Skogvoll, E; Spigset, O, 2007
)
0.34
" On the basis of our data and pharmacokinetic considerations, the majority of drugs commonly used in psychiatry can safely be given in combination with quetiapine."( Quetiapine and drug interactions: evidence from a routine therapeutic drug monitoring service.
Castberg, I; Skogvoll, E; Spigset, O, 2007
)
0.34
"This study examined the efficacy and safety of quetiapine in combination with lithium or divalproex compared with placebo with lithium or divalproex in the prevention of recurrent mood events in bipolar I patients, most recent episode mania, depression, or mixed."( Efficacy and safety of quetiapine in combination with lithium or divalproex for maintenance of patients with bipolar I disorder (international trial 126).
Brecher, M; Eggens, I; Paulsson, B; Persson, I; Suppes, T; Vieta, E, 2008
)
0.35
"Treatment with quetiapine in combination with lithium/divalproex significantly increased the time to recurrence of any mood event compared with placebo plus lithium/divalproex."( Efficacy and safety of quetiapine in combination with lithium or divalproex for maintenance of patients with bipolar I disorder (international trial 126).
Brecher, M; Eggens, I; Paulsson, B; Persson, I; Suppes, T; Vieta, E, 2008
)
0.35
"Maintenance treatment with quetiapine in combination with lithium/divalproex significantly increased time to recurrence of any event (mania, depression, or mixed) irrespective of the polarity of the index episode compared with placebo with lithium/divalproex."( Efficacy and safety of quetiapine in combination with lithium or divalproex for maintenance of patients with bipolar I disorder (international trial 126).
Brecher, M; Eggens, I; Paulsson, B; Persson, I; Suppes, T; Vieta, E, 2008
)
0.35
" After at least 12 weeks of clinical stability, 628 patients were randomly assigned to double-blind treatment with quetiapine or placebo, in combination with lithium or divalproex, for up to 104 weeks."( Maintenance treatment for patients with bipolar I disorder: results from a north american study of quetiapine in combination with lithium or divalproex (trial 127).
Brecher, M; Liu, S; Paulsson, B; Suppes, T; Vieta, E, 2009
)
0.35
" The need to provide effective therapeutic interventions to patients who do not have an optimal response to clozapine is the most common reason for simultaneously prescribing a second antipsychotic drug in combination with clozapine."( Clozapine combined with different antipsychotic drugs for treatment resistant schizophrenia.
Barbui, C; Boso, M; Cipriani, A, 2009
)
0.35
"Clinicians caring for patients infected with the human immunodeficiency virus (HIV) and diagnosed with psychiatric comorbidities must be aware of potential drug-drug interactions, particularly with protease inhibitor-based antiretroviral therapy."( Clinically significant adverse events from a drug interaction between quetiapine and atazanavir-ritonavir in two patients.
McCoy, C; Pollack, TM; Stead, W, 2009
)
0.35
"Quetiapine is now used in the treatment of unipolar and bipolar disorders, both alone and in combination with other medications."( Effects of sustained administration of quetiapine alone and in combination with a serotonin reuptake inhibitor on norepinephrine and serotonin transmission.
Blier, P; Chernoloz, O; El Mansari, M, 2012
)
0.38
" We reexamined all his possible medical conditions and found that the patient had an abnormally enlarged cavus septum pellucidum (CSP) combined with cavum vergae (CV) (maximum length >30 mm)."( A case report on the relationship between treatment-resistant childhood-onset schizophrenia and an abnormally enlarged cavum septum pellucidum combined with cavum vergae.
Hu, SH; Liao, ZL; Xu, Y, 2012
)
0.38
"To determine the efficacy and safety of quetiapine combined with lithium or divalproex for preventing mood events in patients with bipolar I disorder."( Maintenance treatment with quetiapine when combined with either lithium or divalproex in bipolar I disorder: analysis of two large randomized, placebo-controlled trials.
Ekholm, B; Gustafsson, U; Suppes, T; Vieta, E, 2013
)
0.39
"In patients with bipolar I disorder previously stabilized on quetiapine and lithium or divalproex, maintenance therapy with quetiapine significantly increased the time to recurrence of a mood event (mania or depression) versus placebo, regardless of whether it was combined with lithium or divalproex."( Maintenance treatment with quetiapine when combined with either lithium or divalproex in bipolar I disorder: analysis of two large randomized, placebo-controlled trials.
Ekholm, B; Gustafsson, U; Suppes, T; Vieta, E, 2013
)
0.39
" The goal of this study was to investigate the reinforcing effects of quetiapine alone and in combination with intravenous cocaine in monkeys."( Evaluation of the Reinforcing Effect of Quetiapine, Alone and in Combination with Cocaine, in Rhesus Monkeys.
Brutcher, RE; Nader, MA; Nader, SH, 2016
)
0.43
" For these people, a number of treatment strategies have emerged, including the prescription of a second anti-psychotic drug in combination with clozapine."( Clozapine combined with different antipsychotic drugs for treatment-resistant schizophrenia.
Barber, S; Cipriani, A; Corsi, M; Olotu, U, 2017
)
0.46
" Available data indicate to us that all HIV protease inhibitors combined with ritonavir are likely to be strong CYP3A inhibitors."( Dosing Recommendations for Quetiapine When Coadministered With HIV Protease Inhibitors.
Cao, KY; Gish, PL; Hyon, K; Mishra, P; Sampson, MR; Tauber, W; Younis, IR; Zhao, P; Zhou, EH, 2019
)
0.51
" We systematically searched for studies of acute toxicity of quetiapine or other antipsychotics combined with morphine or methadone."( Quetiapine and other antipsychotics combined with opioids in legal autopsy cases: A random finding or cause of fatal outcome?
Andersen, CU; Andersen, FD; Simonsen, U, 2021
)
0.62
"Quetiapine combined with sodium valproate is an effective and more suitable drug treatment for Alzheimer's disease."( Quetiapine Combined with Sodium Valproate in Patients with Alzheimer's Disease with Mental and Behavioral Symptoms Efficacy Observation.
Fu, K; He, X; Liu, W; Xu, J; Xu, P; Zhang, Z, 2022
)
0.72
"Methadone and buprenorphine have pharmacologic properties that are concerning for a high risk of drug-drug interactions (DDIs)."( Identifying Clinically Relevant Drug-Drug Interactions With Methadone and Buprenorphine: A Translational Approach to Signal Detection.
Acton, EK; Bilker, WB; Brensinger, CM; Dawwas, GK; Hennessy, S; Leonard, CE; Li, L; Miano, TA; Neuman, M; Nguyen, TPP; Soprano, SE; Wang, L; Woody, G; Yu, E, 2022
)
0.72
"Polypharmacy increases the risk of potential drug-drug interactions (pDDIs)."( Clinical significance of potential drug-drug interactions in older adults with psychiatric disorders: a retrospective study.
Cui, Y; Ding, Y; Ji, M; Liu, Y; Wang, D; Wang, H; Yang, M; Zhang, H; Zhuang, T, 2022
)
0.72
"In this preliminary study involving healthy participants, paroxetine combined with oxycodone, compared with oxycodone alone, significantly decreased the ventilatory response to hypercapnia on days 1 and 5, whereas quetiapine combined with oxycodone did not cause such an effect."( Effect of Paroxetine or Quetiapine Combined With Oxycodone vs Oxycodone Alone on Ventilation During Hypercapnia: A Randomized Clinical Trial.
Boughner, R; Burkhart, K; Dahan, A; Davis, MC; Florian, J; Ford, K; Gershuny, V; Han, X; Ismaiel, OA; Matta, M; Patel, V; Prentice, K; Racz, R; Rouse, R; Sanabria, C; Shah, A; Stone, M; Strauss, DG; van der Schrier, R; Wang, C; Weaver, J, 2022
)
0.72

Bioavailability

Quetiapine fumarate (QF) suffers from rapid elimination and poor bioavailability due to extensive first-pass effect. The drug has oral bioavailability of 9% because of hepatic first pass metabolism.

ExcerptReferenceRelevance
" The absolute bioavailability is unknown, but the relative bioavailability from orally administered tablets compared with a solution was nearly complete."( Clinical pharmacokinetics of quetiapine: an atypical antipsychotic.
DeVane, CL; Nemeroff, CB, 2001
)
0.31
"The goal of the present study was to assess the relative bioavailability of a new XR formulation of quetiapine 300 mg versus the XR reference product after the administration of a high-fat breakfast as required to assume bioequivalence according to the Uruguayan regulatory authority."( Single-dose relative bioavailability of a new quetiapine fumarate extended-release formulation: a postprandial, randomized, open-label, two-period crossover study in healthy Uruguayan volunteers.
Ercoli, MC; Estevez-Carrizo, FE; Estevez-Parrillo, FT; Parrillo, S, 2011
)
0.37
" This analytical method was applied in a relative bioavailability study in order to compare a test mirtazapine 30 mg single-dose formulation vs a reference formulation in 31 volunteers of both sexes."( A fast, sensitive and simple method for mirtazapine quantification in human plasma by HPLC-ESI-MS/MS. Application to a comparative bioavailability study.
Barrientos-Astigarraga, RE; Borges, NC; Donato, JL; Felix, L; Galvinas, PA; Moreno, P; Moreno, RA; Sverdloff, CE, 2012
)
0.38
" Those CNS drugs which have limited oral bioavailability due to pharmacokinetic consequences and brain barrier repulsion are getting onto this direction."( Comparative study between simple and optimized liposomal dispersion of quetiapine fumarate for diffusion through nasal route.
Pundarikakshudu, K; Sheth, N; Trivedi, J; Upadhyay, P, 2016
)
0.43
" For this, both the formulations were checked and compared for their diffusion profile, as it is an essential property for bioavailability through nasal route."( Comparative study between simple and optimized liposomal dispersion of quetiapine fumarate for diffusion through nasal route.
Pundarikakshudu, K; Sheth, N; Trivedi, J; Upadhyay, P, 2016
)
0.43
" The development of an in vitro-in vivo correlation (IVIVC) and the use of in vitro data to predict in vivo bioavailability parameters has been of great interest for the rational development and evaluation process for extended release dosage forms."( Development of a level A in vitro-in vivo correlation for extended release dosage forms of quetiapine fumarate.
Gonçalves de Lima, L; Rossi de Campos, D, 2016
)
0.43
" Significantly higher brain/blood ratio and 2 folds higher nasal bioavailability in brain with QF-NP in comparison to drug solution following intranasal administration revealed preferential nose to brain transport bypassing blood-brain barrier and prolonged retention of QF at site of action suggesting superiority of chitosan as permeability enhancer."( "Application of Box-Behnken design for optimization and development of quetiapine fumarate loaded chitosan nanoparticles for brain delivery via intranasal route* ".
Khunt, D; Misra, M; Padh, H; Shah, B, 2016
)
0.43
" The aim of this study was to develop QF based microemulsion (ME) with and without chitosan (CH) to investigate its potential use in improving the bioavailability and brain targeting efficiency following non-invasive intranasal administration."( Non-invasive intranasal delivery of quetiapine fumarate loaded microemulsion for brain targeting: Formulation, physicochemical and pharmacokinetic consideration.
Khunt, D; Misra, M; Padh, H; Shah, B, 2016
)
0.43
"Quetiapine fumarate (QF), an anti-schizophrenic drug, suffers from rapid elimination and poor bioavailability due to extensive first-pass effect."( Bio-shielding In Situ Forming Gels (BSIFG) Loaded With Lipospheres for Depot Injection of Quetiapine Fumarate: In Vitro and In Vivo Evaluation.
Abo Elela, MM; Basalious, EB; ElKasabgy, NA, 2017
)
0.46
"Lymphatic route is one of the prominent routes for improving the poor bioavailability of the drugs which undergo extensive hepatic first pass metabolism."( Solid Lipid Nanoparticles Approach for Lymphatic Targeting Through Intraduodenal Delivery of Quetiapine Fumarate.
Gaur, PK; Kumar, SS; Puri, D; Shehkar, P; Yasir, M, 2018
)
0.48
" It exhibited better bioavailability as compared to drug suspension."( Solid Lipid Nanoparticles Approach for Lymphatic Targeting Through Intraduodenal Delivery of Quetiapine Fumarate.
Gaur, PK; Kumar, SS; Puri, D; Shehkar, P; Yasir, M, 2018
)
0.48
"This study was conducted in order to compare the bioavailability of two film-coated tablets containing 25 mg of quetiapine."( A bioequivalence study of quetiapine 25 mg film-coated tablets in healthy Indonesian subjects
.
Harahap, Y; Lusthom, W; Prasaja, B; Sinandang, T; Yusvita, LY, 2018
)
0.48
"Quetiapine fumarate, a 2nd generation anti-psychotic drug has oral bioavailability of 9% because of hepatic first pass metabolism."( Quality by Design Approach for Development and Characterisation of Solid Lipid Nanoparticles of Quetiapine Fumarate.
Agarwal, S; Garg, R; Harikumar, SL; Murthy, RSR, 2020
)
0.56
"QF, an anti-psychotic drug, has an oral bioavailability of 9% due to hepatic first- pass metabolism necessitating the use of high doses."( Quetiapine Fumarate Loaded Nanostructured Lipid Carrier for Enhancing Oral Bioavailability: Design, Development and Pharmacokinetic Assessment.
Agarwal, S; Garg, R; HariKumar, SL; Negi, P; Upadhyay, N, 2021
)
0.62
"The objective of the study was the enhancement of bioavailability of the NLC of QF by preferential lymphatic uptake."( Quetiapine Fumarate Loaded Nanostructured Lipid Carrier for Enhancing Oral Bioavailability: Design, Development and Pharmacokinetic Assessment.
Agarwal, S; Garg, R; HariKumar, SL; Negi, P; Upadhyay, N, 2021
)
0.62
"The results validated DoE as an appropriate tool for developing QF loaded NLC and proved NLC to be a promising delivery system for the enhancement of oral bioavailability of QF."( Quetiapine Fumarate Loaded Nanostructured Lipid Carrier for Enhancing Oral Bioavailability: Design, Development and Pharmacokinetic Assessment.
Agarwal, S; Garg, R; HariKumar, SL; Negi, P; Upadhyay, N, 2021
)
0.62
"Quetiapine (QTP) is a first-line antipsychotic drug, but its therapeutic druggability and patient adherence were limited due to high oral dose strength, low bioavailability and physicochemical/biopharmaceutical issues."( Roles of Fatty Acid Chain Length and Enzyme-Oriented Drug Controlled Release from pH-Triggering Self-Assembled Fatty Acid Conjugated Quetiapine Nanosuspensions.
Gil, MC; Lee, BJ; Ngo, HV; Nguyen, HD; Nguyen, VH, 2023
)
0.91

Dosage Studied

Extended release quetiapine fumarate is a new formulation that allows once-daily dosing and a titration regimen that is simpler than that of immediate release. Seroquel XR was developed using a quality by design/design of experiment (QbD/DoE) paradigm.

ExcerptRelevanceReference
" In the present study, 12 patients suffering from schizophrenia or schizophreniform disorder with predominantly positive symptomatology were treated in an open clinical trial for 4 weeks with seroquel at a maximum dosage of 750 mg/day."( Seroquel (ICI 204 636), a putative "atypical" antipsychotic, in schizophrenia with positive symptomatology: results of an open clinical trial and changes of neuroendocrinological and EEG parameters.
Benkert, O; Hain, C; Schlegel, S; Szegedi, A; Wetzel, H; Wiesner, J, 1995
)
0.29
" Seroquel's restoration of PPI in apomorphine-treated rats follows simple monotonic ascending dose-response properties, and is not accompanied by consistent changes in startle reflex amplitude."( Seroquel (ICI 204,636) restores prepulse inhibition of acoustic startle in apomorphine-treated rats: Similarities to clozapine.
Swerdlow, NR; Taaid, N; Zisook, D, 1994
)
0.29
" However, risperidone induced a U-shaped dose-response curve."( Differential effects of repeated administration of novel antipsychotic drugs on the activity of midbrain dopamine neurons in the rat.
Skarsfeldt, T, 1995
)
0.29
"Five fixed doses of the atypical antipsychotic "Seroquel" (quetiapine) were evaluated to delineate a dose-response relationship, as measured by changes from baseline in Brief Psychiatric Rating Scale (BPRS), Clinical Global Impression (CGI), and Modified Scale for the Assessment of Negative Symptoms (SANS) summary scores, and to compare efficacy and tolerability opposite placebo and haloperidol."( Multiple fixed doses of "Seroquel" (quetiapine) in patients with acute exacerbation of schizophrenia: a comparison with haloperidol and placebo. The Seroquel Trial 13 Study Group.
Arvanitis, LA; Miller, BG, 1997
)
0.3
" However, since dopamine D2 receptor occupancies correlate poorly with plasma concentrations of antipsychotics, plasma elimination half-life may not predict either duration of clinical effect or dosing frequency."( A comparison of bd and tid dose regimens of quetiapine (Seroquel) in the treatment of schizophrenia.
King, DJ; Kowalcyk, B; Link, CG, 1998
)
0.3
" Quetiapine interacts with phenytoin, carbamazepine, barbiturates, rifampin and glucocorticoids; and coadministration with these drugs may require dosage adjustment."( Quetiapine: a new atypical antipsychotic.
Erpenbach, JE; Fuller, WC; Hamlyn, H; Misra, LK, 1998
)
0.3
" A steady-state treatment condition was ensured by dosing the patients with 750 mg quetiapine daily during 3 weeks followed by a period of tapering off the dose."( N-[11C]methylspiperone PET, in contrast to [11C]raclopride, fails to detect D2 receptor occupancy by an atypical neuroleptic.
Bergström, M; Gefvert, O; Hagberg, G; Långström, B; Lindström, L; Wiesel, FA; Wieselgren, IM, 1998
)
0.3
" Dosing requirements for elderly patients tend to be much lower than those for younger adults."( Conventional vs. newer antipsychotics in elderly patients.
Harris, MJ; Jeste, DV; Lacro, J; Lohr, JB; Rockwell, E, 1999
)
0.3
" The atypical properties of first-line atypical antipsychotics as well as clozapine are reviewed here, with clinical pearls and dosing tips for each based upon a consensus of information from both clinical trials and clinical practice."( Selecting an atypical antipsychotic by combining clinical experience with guidelines from clinical trials.
Stahl, SM, 1999
)
0.3
" Published studies have drawn criticism in terms of inappropriate titration schedules, nonequivalent dosing between treatment groups, short treatment duration, and inadequate sample sizes."( Clozapine: a comparison with other novel antipsychotics.
Fleischhacker, WW, 1999
)
0.3
" The effective dosage range is usually 300-450 mg/day split into two doses."( Focus on quetiapine.
Green, B, 1999
)
0.3
" Surprisingly, there has been little relationship between the pivotal trials designed for FDA approval and current dosing strategies in broader clinical settings."( New antipsychotic medications: more than old wine and new bottles.
Schulz, SC, 2000
)
0.31
"Quetiapine shows a transiently high D2 occupancy, which decreases to very low levels by the end of the dosing interval."( A positron emission tomography study of quetiapine in schizophrenia: a preliminary finding of an antipsychotic effect with only transiently high dopamine D2 receptor occupancy.
Jones, C; Kapur, S; Remington, G; Seeman, P; Shammi, CS; Zipursky, R, 2000
)
0.31
" The results indicate that dosage adjustment of quetiapine may be unnecessary in psychotic patients with decreased renal function."( Single-dose pharmacokinetics of quetiapine in subjects with renal or hepatic impairment.
Thyrum, PT; Wong, YW; Yeh, C, 2000
)
0.31
" We also provide evidence of deficient NT neurotransmission as well as a left-shifted antipsychotic drug dose-response curve in isolation-reared rats."( Enhanced neurotensin neurotransmission is involved in the clinically relevant behavioral effects of antipsychotic drugs: evidence from animal models of sensorimotor gating.
Binder, EB; Kilts, CD; Kinkead, B; Nemeroff, CB; Owens, MJ, 2001
)
0.31
" These results indicate that dosage adjustment of quetiapine may be necessary when the two drugs are given concurrently and that caution may be required when administering other drugs that inhibit or induce cytochromes, particularly P450 3A4."( The effects of concomitant phenytoin administration on the steady-state pharmacokinetics of quetiapine.
Thyrum, PT; Wong, YW; Yeh, C, 2001
)
0.31
" Quetiapine has a wide clinical dosing range (150-750 mg/day), although doses of 400 mg or above should be used in patients who do not fully respond to lower doses of the drug."( Review of quetiapine and its clinical applications in schizophrenia.
Kasper, S; Müller-Spahn, F, 2000
)
0.31
" Quetiapine dosage adjustment, therefore, may be necessary when coadministered with phenytoin, thioridazine or other potent CYP3A4 inducers or inhibitors."( Clinical pharmacokinetics of quetiapine: an atypical antipsychotic.
DeVane, CL; Nemeroff, CB, 2001
)
0.31
" Risk factors are a high dosage of antipsychotics, akathisia in a previous treatment, and diabetes mellitus."( [Drug-induced akathisia].
van Harten, PN, 2002
)
0.31
"A 27-year-old white woman was observed to have a seizure while receiving a stable dosage of olanzapine 15 mg/d, with the addition of quetiapine 100 mg in the evening 1 day before the occurrence of the seizure."( New-onset seizure associated with quetiapine and olanzapine.
Hedges, DW; Jeppson, KG, 2002
)
0.31
" Key assessments included the pharmacokinetics of quetiapine at steady state (area under the curve within a dosing interval [AUCtSS], maximum [CmaxSS], and minimum [CminSS] observed plasma concentrations, and oral clearance [Cl/f]), as well as the UKU Side Effect Rating Scale scores and safety evaluations."( The safety and pharmacokinetics of quetiapine when coadministered with haloperidol, risperidone, or thioridazine.
Alva, G; Arvanitis, LA; Bera, R; Potkin, SG; Thyrum, PT; Yeh, C, 2002
)
0.31
" Fluoxetine increased the quetiapine area under the plasma concentration time curve during a 12-hour interval (+12%), maximum plasma concentration during the dosing interval (C(ss)(max); +26%), and minimum plasma concentration at the end of the dosing interval (+8%), although it decreased oral clearance (-11%)."( Effect of fluoxetine and imipramine on the pharmacokinetics and tolerability of the antipsychotic quetiapine.
Alva, G; Arvanitis, LA; Carreon, D; Kalali, A; Potkin, SG; Thyrum, PT; Yeh, C, 2002
)
0.31
" Quetiapine dosage was adjusted according to therapeutic effects."( Therapeutic tolerance and rebound psychosis during quetiapine maintenance monotherapy in patients with schizophrenia and schizoaffective disorder.
Beauclair, L; Bélanger, MC; Chouinard, G; Margolese, HC, 2002
)
0.31
" He was started on paroxetine, with increases in dosage and no significant improvement."( Quetiapine therapy for posttraumatic stress disorder.
Bhatia, SC; Grant, K; Petty, F; Sattar, SP; Ucci, B, 2002
)
0.31
" Although not affected by smoking, alterations in quetiapine disposition due to age or hepatic impairment are manageable by appropriate dosage reduction."( Quetiapine: preclinical studies, pharmacokinetics, drug interactions, and dosing.
Goldstein, J; Kinkead, B; Nemeroff, CB, 2002
)
0.31
"Utilizing a double-blind design, 21 hospitalized adult men or women with DSM-IV schizophrenia or schizoaffective disorder, who had received unchanged doses (for 2 weeks) of either 400 or 600 mg daily of quetiapine administered in 2 doses, were randomly assigned to once- or twice-daily administration for 4 weeks and then crossed over to the opposite dosing regimen for an additional 4 weeks."( A random-assignment, double-blind, clinical trial of once- vs twice-daily administration of quetiapine fumarate in patients with schizophrenia or schizoaffective disorder: a pilot study.
Brar, JS; Chengappa, KN; Goldstein, JM; Mullen, J; Parepally, H; Shilling, A, 2003
)
0.32
"These pilot data suggest that it is clinically feasible to switch most quetiapine-treated subjects receiving a therapeutic twice-daily dosing schedule to a once-daily regimen."( A random-assignment, double-blind, clinical trial of once- vs twice-daily administration of quetiapine fumarate in patients with schizophrenia or schizoaffective disorder: a pilot study.
Brar, JS; Chengappa, KN; Goldstein, JM; Mullen, J; Parepally, H; Shilling, A, 2003
)
0.32
" Subjects had completed a pharmacokinetic study over 23 days, during which the dosage of quetiapine was increased sequentially from 25 mg bid to a maximum of 400 mg bid (800 mg/day) (McConville et al."( Long-term safety, tolerability, and clinical efficacy of quetiapine in adolescents: an open-label extension trial.
Browne, K; Carrero, L; Chaney, R; Foster, K; Friedman, L; McConville, B; Potter, L; Sorter, M; Sweitzer, D, 2003
)
0.32
" However, no correlation between prolactin levels and dosage could be found."( [Plasma prolactin level and incidence of adverse endocrinologic effects during therapy with atypical neuroleptics].
Fric, M; Laux, G, 2003
)
0.32
" Typical dosage was 600 to 800 mg per day."( Treating impulsivity, irritability, and aggression of antisocial personality disorder with quetiapine.
Allen, TS; Thomas, J; Walker, C, 2003
)
0.32
"Twelve patients with DSM-IV delirium were treated with flexible doses of open-label quetiapine (mean +/- SD dosage = 44."( A prospective, open-label, flexible-dose study of quetiapine in the treatment of delirium.
Denda, K; Inoue, S; Inoue, T; Koyama, T; Matsuyama, T; Sasaki, Y; Sunami, T, 2003
)
0.32
" Unfortunately, this type of drugs cannot block the D2 receptors only in the mesolimbic dopaminergic pathway (which mediates their therapeutic effects), because of their non-selective D2 receptor blockage in both the mesolimbic and striatal regions, and the consequent appearance of side effects related to striatal interaction in the same dosage range as is needed for the therapeutical effects."( New antipsychotics and schizophrenia: a review on efficacy and side effects.
Berardi, D; De Ronchi, D; Lorenzi, C; Serretti, A, 2004
)
0.32
" The clinical dosage regime caused no drug accumulation."( Multiple dose pharmacokinetics of quetiapine and some of its metabolites in Chinese suffering from schizophrenia.
Cheng, ZN; Li, HD; Li, KY; Li, X; Peng, WX; Zhang, BK, 2004
)
0.32
" Patients receiving a stable dosage of an SSRI for at least 6 weeks who also had persistent anxiety symptoms (Hamilton Anxiety scale [HAM-A] > or =16), were enrolled in a 9-week, open-label, variable dose study."( Preliminary experience with adjunctive quetiapine in patients receiving selective serotonin reuptake inhibitors.
Adson, DE; Eiben, KM; Kushner, MG; Schulz, SC, 2004
)
0.32
") Furthermore, while current prescribing information recommends that quetiapine be administered at doses up to 750 mg/day (800 mg/day in the USA and Canada), there is growing evidence that dosing up to 1600 mg/day of quetiapine has been well tolerated in some patients."( Managing acute exacerbations of schizophrenia: focus on quetiapine.
Arango, C; Bobes, J, 2004
)
0.32
" A mean therapeutic dosage for Seroquel was 316."( [Influence of long-term quetiapine (Seroquel) and haloperidol therapy on cognitive deficit in patients with paranoid schizophrenia].
Kabanov, SO; Mosolov, SN, 2004
)
0.32
" However, should future studies be performed, it seems reasonable that they be conducted with more rigor, less treatment-resistant cohorts, and, possibly, a different dosing strategy."( Quetiapine in nine youths with autistic disorder.
Blumer, JL; Demeter, C; Findling, RL; Gracious, BL; McNamara, NK; O'Riordan, MA; Reed, MD, 2004
)
0.32
" However, the results suggest that quetiapine, when given within the recommended dosage range, has a benign EPS profile, with potentially greater tolerability and comparable efficacy to risperidone in older outpatients with psychotic disorders."( A comparison of extrapyramidal symptoms in older outpatients treated with quetiapine or risperidone.
Mintzer, JE; Mullen, JA; Sweitzer, DE, 2004
)
0.32
"7 years; range, 5-28 years) received a quetiapine trial (mean +/- SD dosage = 248."( A retrospective analysis of quetiapine in the treatment of pervasive developmental disorders.
Barkenbus, JE; Corson, AH; McDougle, CJ; Posey, DJ; Stigler, KA, 2004
)
0.32
"A significant positive correlation of the serum concentration and the daily dosage was found."( [Determining serum concentrations of the modern antipsychotic quetiapin: clinical relevance in therapeutic drug monitoring].
Köhnlein, O; Lutz, R; Messer, T; Schmauss, M, 2004
)
0.32
"While a correlation of dosage and effect could be shown with Quetiapin, inter- and intraindividual differences could be observed."( [Determining serum concentrations of the modern antipsychotic quetiapin: clinical relevance in therapeutic drug monitoring].
Köhnlein, O; Lutz, R; Messer, T; Schmauss, M, 2004
)
0.32
" When quetiapine is co-administered with CYP3A inhibitors such as erythromycin, the dosing regimen should be modified according to quetiapine TDM."( Effect of erythromycin on metabolism of quetiapine in Chinese suffering from schizophrenia.
Cheng, ZN; Li, HD; Li, KY; Li, X; Peng, WX; Zhang, BK, 2005
)
0.33
"In an international, multicenter, double-blind, parallel-group, 12-week study, patients with a DSM-IV diagnosis of bipolar I disorder (manic episode) were randomly assigned to treatment with quetiapine (flexibly dosed up to 800 mg/day), placebo, or lithium."( A randomized, double-blind, placebo-controlled efficacy and safety study of quetiapine or lithium as monotherapy for mania in bipolar disorder.
Bowden, CL; Brecher, M; Grunze, H; Jones, M; Mullen, J; Paulsson, B; Svensson, K; Vågerö, M, 2005
)
0.33
" Mice were acclimated to individual housing, given ad libitum access to chow and water, dosed with placebo peanut butter pills for 1 week, and then dosed daily with AAPD-laced peanut butter pills for 4 weeks."( Antipsychotic drug-induced weight gain: development of an animal model.
Allison, DB; Casey, DE; Cope, MB; Fernández, JR; Geary, N; Nagy, TR, 2005
)
0.33
" CYP3A4 is the primary enzyme responsible for CYP-mediated metabolism of QTP in clinical therapy dosage in vivo."( Metabolic mechanism of quetiapine in vivo with clinical therapeutic dose.
Cheng, ZN; Li, HD; Li, KY; Li, X, 2005
)
0.33
" Dosage alterations of olanzapine and clozapine, dependent on cytochrome P450 1A2 (CYP1A2) for clearance, and quetiapine, dependent on cytochrome P450 3A (CYP3A), may be necessary when used with other drugs that inhibit or induce their metabolic enzymes."( The dosing of atypical antipsychotics.
Armstrong, SC; Cozza, KL; de Leon, J,
)
0.13
" Clinicians were instructed to target dosing at 500 mg/day of quetiapine or 200 mg of haloperidol decanoate every 4 weeks."( Long-term maintenance therapy with quetiapine versus haloperidol decanoate in patients with schizophrenia or schizoaffective disorder.
Glick, ID; Marder, SR, 2005
)
0.33
" Among the classes of medications that are H1 antagonists we point out that atypical antipsychotic medications such as olanzapine and quetiapine are among the most potent H1 antagonists, and can have simple daily dosing schedules and thus may be particularly useful in ACD."( Using histamine (H1) antagonists, in particular atypical antipsychotics, to treat anemia of chronic disease via interleukin-6 suppression.
Altschuler, EL; Kast, RE, 2005
)
0.33
"The original dosing recommendations for quetiapine in the treatment of schizophrenia suggested escalation to 400 mg/d using the following schedule, administered twice daily in divided doses: Day 1, 50 mg; Day 2, 100 mg; Day 3, 200 mg; Day 4, 300 mg; Day 5, 400 mg."( Rapid dose escalation with quetiapine: a pilot study.
Brecher, M; Hamer-Maansson, J; McCoy, R; Smith, MA, 2005
)
0.33
" Olanzapine might be useful for delusion of PD in patients not responded to quetiapine, although it should be started at a very low dosage to ameliorate worsening parkinsonism."( [The efficacy of olanzapine for delusion in patients with Parkinson's disease].
Atsuta, N; Hirayama, M; Ito, M; Sobue, G; Watanabe, H, 2005
)
0.33
"Patients (n=302) with bipolar I disorder (manic episode) were randomised to 12 weeks' double-blind treatment with quetiapine (flexibly dosed up to 800 mg/day), placebo, or haloperidol (up to 8 mg/day)."( Quetiapine or haloperidol as monotherapy for bipolar mania--a 12-week, double-blind, randomised, parallel-group, placebo-controlled trial.
Brecher, M; Huizar, K; McIntyre, RS; Mullen, J; Paulsson, B, 2005
)
0.33
" Patients were initiated with quetiapine to 400 mg/day over 7 days, and then flexibly dosed (300-750 mg/day) for 11 weeks."( Efficacy and tolerability of quetiapine in patients with schizophrenia who switched from haloperidol, olanzapine or risperidone.
Altman, C; de Nayer, A; Jones, AM; Larmo, I; Lindenbauer, B; Platz, T; Rittmannsberger, H; Windhager, E, 2005
)
0.33
" Forty patients with delirium were randomly assigned to either AMSP or QTP groups, with a flexible dosing schedule."( Amisulpride versus quetiapine for the treatment of delirium: a randomized, open prospective study.
Bahk, WM; Kweon, YS; Lee, CT; Lee, HK; Lee, KU; Pae, CU; Won, WY, 2005
)
0.33
" To our knowledge, this represents the second published report associating quetiapine with priapism, and the first to associate priapism with routine dosing of the drug."( Priapism associated with routine use of quetiapine: case report and review of the literature.
Davol, P; Rukstalis, D, 2005
)
0.33
" Based on the results of this study, it appears that quetiapine is an efficacious and safe treatment for geriatric inpatients with psychosis, however, there is a wide dosing range and optimal dosage is diagnosis-dependent."( The efficacy and safety of quetiapine for treatment of geriatric psychosis.
Hwang, JP; Tsai, SJ; Yang, CH, 2005
)
0.33
" The purpose of this article is to review the past and present dosing patterns of quetiapine for the treatment of schizophrenia."( Dosing of quetiapine in schizophrenia: how clinical practice differs from registration studies.
Citrome, L; Jaffe, A; Levine, J; Lindenmayer, JP, 2005
)
0.33
" Trends in dosing of quetiapine in a large, state-operated psychiatric hospital system and the anecdotal evidence describing the use of quetiapine in excess of 800 mg/day were also reviewed."( Dosing of quetiapine in schizophrenia: how clinical practice differs from registration studies.
Citrome, L; Jaffe, A; Levine, J; Lindenmayer, JP, 2005
)
0.33
" The symptoms reduced remarkably when fluoxetine was added to her treatment regimen while keeping the quetiapine dosage unchanged."( Obsessive compulsive symptoms associated with quetiapine treatment in a schizophrenic patient: a case report.
Arsava, M; Demir, B; Ertuğrul, A; Ozer, S, 2006
)
0.33
" TDM and pharmacogenetic tests are useful tools to improve pharmacotherapy by preventing dose-dependent adverse drug events, optimizing dosage during long-term treatment and identifying ultrarapid metabolizers and malcompliance."( [Therapeutic drug monitoring: A pharmacotherapeutic tool in psychiatry].
Etzensberger, M; Jaquenoud Sirot, E; Stephan, PL, 2006
)
0.33
" Atypical antipsychotics are an alternative treatment, and this 12-week, randomised, flexibly dosed study compared the efficacy, safety and tolerability of quetiapine and olanzapine in this regard."( Quetiapine versus olanzapine for the treatment of negative symptoms in patients with schizophrenia.
Koren, A; Pannet, I; Sirota, P; Tchernichovsky, E, 2006
)
0.33
" The PK of quetiapine supports twice-daily dosing in children with CD."( Effectiveness, safety, and pharmacokinetics of quetiapine in aggressive children with conduct disorder.
Demeter, CA; Findling, RL; McNamara, NK; O'Riordan, MA; Reed, MD; Stansbrey, RJ, 2006
)
0.33
"Quetiapine demonstrated some efficacy as a sedative agent in the emergency setting, although no clear dose-response pattern emerged over the narrow dose range tested."( A pilot, open-label safety study of quetiapine for treatment of moderate psychotic agitation in the emergency setting.
Currier, GW; Trenton, AJ; van Wijngaarden, E; Walsh, PG, 2006
)
0.33
" Adverse effects were evaluated using the Dosage Record and Treatment Emergent Symptom Scale."( Efficacy and tolerability of quetiapine in the treatment of borderline personality disorder: A pilot study.
Bellino, S; Bogetto, F; Paradiso, E, 2006
)
0.33
" Quetiapine, flexibly dosed (25-100 mg/day), was added to their original treatment regimen for 12 weeks."( An open-label study of quetiapine in the treatment of fibromyalgia.
Calandre, EP; Hidalgo, J; Rico-Villademoros, F, 2007
)
0.34
"The authors conducted a multicenter, double-blind, placebo-controlled, randomized trial of flexibly dosed quetiapine and haloperidol."( Quetiapine treatment of psychosis associated with dementia: a double-blind, randomized, placebo-controlled clinical trial.
Copenhaver, M; Katz, IR; Mintzer, JE; Schneider, L; Street, J; Tariot, PN; Williams-Hughes, C, 2006
)
0.33
" We added quetiapine to patients' medication and attempted to increase the dosage to at least 400 mg daily."( Add-on quetiapine for bipolar depression: a 12-month open-label trial.
Abraham, G; Milev, R; Zaheer, J, 2006
)
0.33
"29 BPD outpatients entered, and 23 completed, a 12 week, open-label, regime of quetiapine at an average daily dosage of 540 mg (range: 400-800 mg)."( Quetiapine for the treatment of borderline personality disorder; an open-label study.
Carrus, D; Costa, E; Perrella, C; Schifano, F, 2007
)
0.34
", dosage adjustments, behavioral or psychosocial interventions) before switching medications."( Effectiveness of switching antipsychotic medications.
Covell, NH; Davis, SM; Essock, SM; Lieberman, JA; Rosenheck, RA; Stroup, TS, 2006
)
0.33
" Patients were randomised to either lithium or quetiapine in addition to the maximally dosed antidepressant and any other concurrent medications."( Quetiapine augmentation of treatment-resistant depression: a comparison with lithium.
Des Rosiers, J; Dorée, JP; Elie, R; Gendron, A; Lew, V; Stip, E; Tourjman, SV, 2007
)
0.34
" The aim of the present study was to evaluate the effectiveness, tolerability and clinical reasons associated to the use of high dosage of quetiapine (>800 mg), when used under routine clinical conditions, in a sample of bipolar disorder and schizoaffective bipolar inpatients."( Quetiapine dosage in bipolar disorder episodes and mixed states.
Chatton, A; Khazaal, Y; Preisig, M; Rothen, S; Tapparel, S; Zullino, D, 2007
)
0.34
"5 microg/mL) (Li/DVP) (for 3-6 weeks) in four double-blind, placebo-controlled studies according to a predetermined dosing schedule."( Quetiapine in the treatment of acute mania: target dose for efficacious treatment.
Goldberg, JF; Mullen, J; Paulsson, B; Vågerö, M; Vieta, E, 2007
)
0.34
" Dose escalation was rapid, with 92% of patients treated with monotherapy and 80% of patients treated with combination therapy reaching doses of 400 mg/day by Day 4, in accordance with protocol-defined dosing guidance."( Quetiapine in the treatment of acute mania: target dose for efficacious treatment.
Goldberg, JF; Mullen, J; Paulsson, B; Vågerö, M; Vieta, E, 2007
)
0.34
"Thirty-eight outpatients on long-term treatment with clozapine (250-500 mg/d, n = 10), olanzapine (10-20 mg/d, n = 12), risperidone (3-6 mg/d, n = 9), or quetiapine (200-600 mg/d, n = 7) received adjunctive topiramate, gradually titrated up to a final dosage of 200 mg/d for 6 weeks."( Effect of topiramate on plasma concentrations of clozapine, olanzapine, risperidone, and quetiapine in patients with psychotic disorders.
Bruno, A; Cacciola, M; Campolo, D; Cortese, L; D'Arrigo, C; Migliardi, G; Santoro, V; Spina, E,
)
0.13
" An unexpectedly large placebo effect, inadequate dosage (mean 120 mg/day), and inadequate power may have contributed to lack of demonstrable benefit."( Quetiapine for agitation or psychosis in patients with dementia and parkinsonism.
Cummings, J; Kurlan, R; Raman, R; Thal, L, 2007
)
0.34
" Inpatients (n = 269) diagnosed with schizophrenia or schizoaffective disorder received rapid (n = 139) or conventional (n = 130) initiation of quetiapine, followed by flexible dosing (maximum 800 mg/day)."( Rapid dose initiation of quetiapine for the treatment of acute schizophrenia and schizoaffective disorder: a randomised, multicentre, parallel-group, open study.
Boidi, G; Ferro, M, 2007
)
0.34
"Steady-state plasma concentrations of (R)- (ie, the active form), (S)-, and (R,S)-methadone were measured in 14 addict patients in methadone maintenance treatment, before and after introduction of quetiapine, administered at a mean dosage of 138 mg/d (SD, 87 mg/d; median, 125 mg/d; range, 50-300 mg/d) during a mean period of 30 days (SD, 8 days; median, 30 days; range, 20-48 days)."( Increased (R)-methadone plasma concentrations by quetiapine in cytochrome P450s and ABCB1 genotyped patients.
Brawand-Amey, M; Brocard, M; Chassot, P; Crettol, S; Eap, CB; Koeb, L; Uehlinger, C, 2007
)
0.34
"An open-label, nonrandomized trial was conducted in 41 patients with rapid-cycling bipolar disorder (type I=33, type II=7, NOS=1) who received flexibly dosed quetiapine monotherapy (n=19) or add-on therapy (n=22) for up to one year."( Effectiveness of quetiapine in rapid cycling bipolar disorder: a preliminary study.
Filkowski, MM; Goldberg, JF; Hsu, DJ; Kelley, ME; Nassir Ghaemi, S; Rosenquist, KJ, 2008
)
0.35
" Quetiapine and valproic acid plasma concentration-time data over a 12-h steady-state dosing interval were used to determine C(max), T(max), C(min), area under the plasma concentration-time curve (AUC(tau)), and oral clearance (CL/F)."( Open-label steady-state pharmacokinetic drug interaction study on co-administered quetiapine fumarate and divalproex sodium in patients with schizophrenia, schizoaffective disorder, or bipolar disorder.
Davis, PC; DeVane, CL; Ennis, DJ; Figueroa, C; Hamer-Maansson, JE; Smith, MA; Winter, HR, 2007
)
0.34
"The trial was a prospective, open-label, single-center one with a flexible dosing of SGAs."( Differences in the effect of second-generation antipsychotics on prolactinaemia: six weeks open-label trial in female in-patients.
Cejpková, A; Rodáková, I; Svestka, J; Synek, O; Tomanová, J, 2007
)
0.34
" A 'high-dose' theory of quetiapine activity has developed, leading many prescribers to disregard the formal upper limit of the quetiapine dosage range (750 or 800 mg/day, depending on local labelling)."( Quetiapine: dose-response relationship in schizophrenia.
Jones, S; Sparshatt, A; Taylor, D, 2008
)
0.35
" Phase 1 consisted of 10 weeks of open-label paroxetine CR flexibly dosed to a maximum of 62."( Quetiapine augmentation of paroxetine CR for the treatment of refractory generalized anxiety disorder: preliminary findings.
Connor, KM; Davidson, JR; Hoge, EA; LeBeau, RT; Pollack, MH; Simon, NM; Worthington, JJ; Zhang, W, 2008
)
0.35
" The predictability in quetiapine concentration profiles for children aged 10 years to adults suggests that no dosage adjustment may be required when treating patients of these ages."( Steady-state pharmacokinetic, safety, and tolerability profiles of quetiapine, norquetiapine, and other quetiapine metabolites in pediatric and adult patients with psychotic disorders.
Davis, PC; Earley, WR; Hamer-Maansson, JE; Smith, MA; Winter, HR, 2008
)
0.35
" For patients receiving standing dose regimens, diagnosis, total daily dose, and dosing adequacy were ascertained."( Patterns of quetiapine use in psychiatric inpatients: an examination of off-label use.
Carpenter, LL; Mello, K; Philip, NS; Price, LH; Tyrka, AR,
)
0.13
" Patients receiving prn dosing had a similar distribution of diagnoses."( Patterns of quetiapine use in psychiatric inpatients: an examination of off-label use.
Carpenter, LL; Mello, K; Philip, NS; Price, LH; Tyrka, AR,
)
0.13
" An extended-release (XR) formulation of quetiapine is currently being developed to achieve similar efficacy using a once-daily dosing regimen."( Quetiapine extended-release versus immediate-release formulation: a positron emission tomography study.
Barsoum, P; Gendron, A; Goldstein, J; Kapur, S; Mamo, DC; Uchida, H; Vitcu, I, 2008
)
0.35
"Once-daily dosing of the XR formulation gives peak and trough plasma levels and central D(2) receptor occupancy comparable to twice-daily dosing of the IR formulation."( Quetiapine extended-release versus immediate-release formulation: a positron emission tomography study.
Barsoum, P; Gendron, A; Goldstein, J; Kapur, S; Mamo, DC; Uchida, H; Vitcu, I, 2008
)
0.35
" Quetiapine XR has been developed to reduce the frequency of quetiapine dosing by introducing once-daily administration and to simplify the treatment initiation schedule."( [Administration of once-daily extended release quetiapine in schizophrenic disorders].
Bartkó, G, 2007
)
0.34
" Quetiapine was flexibly dosed starting at 25 mg to a maximum of 100 mg daily."( A randomized, double-blind, and placebo-controlled trial of quetiapine augmentation of fluoxetine in major depressive disorder.
Fava, M; Garakani, A; Hirschowitz, J; Marcus, S; Martinez, JM; Rickels, K; Weaver, J, 2008
)
0.35
" Treatment was at the psychiatrist's discretion, including flexible dosing and use of concomitant therapies and medications, with assessments at 0, 3, 6, 12, 18, 24, 30, and 36 months."( Long-term antipsychotic monotherapy for schizophrenia: disease burden and comparative outcomes for patients treated with olanzapine, quetiapine, risperidone, or haloperidol monotherapy in a pan-continental observational study.
Anders, M; Dossenbach, M; Irimia, V; Kotler, M; Logozar-Perkovic, D; Lowry, AJ; Pecenak, J; Peciukaitiene, D; Smulevich, AB; Szulc, A; Treuer, T; West, TM, 2008
)
0.35
"Quetiapine was assessed in patients diagnosed with borderline personality disorder (BPD) to examine its potential effect on symptoms and explore a tolerated dosing pattern."( Quetiapine in patients with borderline personality disorder: an open-label trial.
Brown, E; Lee, S; Romine, A; Schulz, SC; Thuras, P,
)
0.13
" The dosing strategy in the study was well tolerated."( Quetiapine in patients with borderline personality disorder: an open-label trial.
Brown, E; Lee, S; Romine, A; Schulz, SC; Thuras, P,
)
0.13
" In contrast to multiepisode patients, dosing should be more conservative in untreated new-onset cases."( Dosing quetiapine in drug-naive first-episode psychosis: a controlled, double-blind, randomized, single-center study investigating efficacy, tolerability, and safety of 200 mg/day vs. 400 mg/day of quetiapine fumarate in 141 patients aged 15 to 25 years.
Amminger, PG; Berger, GE; Kerr, M; Lubman, D; Markulev, C; McConchie, M; McGorry, PD; O'Donnell, C; Polari, A; Proffitt, TM; Wood, S; Yuen, HP, 2008
)
0.35
" Logistic regressions were carried-out to assess links between quetiapine discharge dosage (> or =800 mg/day vs."( Quetiapine dosage across diagnostic categories.
Chatton, A; Khan, R; Khazaal, Y; Zullino, D, 2009
)
0.35
"Quetiapine seems to be used in a variety of clinical situations, with a wide range of doses and a lower dosage in patients treated for personality disorders."( Quetiapine dosage across diagnostic categories.
Chatton, A; Khan, R; Khazaal, Y; Zullino, D, 2009
)
0.35
" Patient characteristics, prescribing provider characteristics, length of therapy, and dosing were examined."( Patterns of atypical antipsychotic subtherapeutic dosing among Oregon Medicaid patients.
Hamer, AM; Hartung, DM; Haxby, DG; McFarland, BH; Middleton, L; Pollack, DA; Wisdom, JP, 2008
)
0.35
"Among 830 individuals in our sample who began treatment with an atypical antipsychotic, only 15% had a documented diagnosis of schizophrenia, subtherapeutic dosing was common (up to 86% of patients taking quetiapine), and 40% continued less than 30 days with the index prescription."( Patterns of atypical antipsychotic subtherapeutic dosing among Oregon Medicaid patients.
Hamer, AM; Hartung, DM; Haxby, DG; McFarland, BH; Middleton, L; Pollack, DA; Wisdom, JP, 2008
)
0.35
" Articles providing support for appropriate dosing of quetiapine were distributed to physicians, and peer discussions about prescribing practices were held."( Best practices: an intervention to promote evidence-based prescribing at a large psychiatric hospital.
Fabian, TJ; Ghinassi, FA; Haskett, RF; Nash, KC; Stowell, KR, 2009
)
0.35
" Unique characteristics in this case included length of therapy without dosage change or titration and no known history of drug-related EPS."( Neuroleptic malignant syndrome secondary to quetiapine.
Fagan, A; Gortney, JS; Kissack, JC, 2009
)
0.35
" Clinicians should be aware that NMS with EPS can occur with quetiapine at steady state doses without recent dosage adjustments or titration."( Neuroleptic malignant syndrome secondary to quetiapine.
Fagan, A; Gortney, JS; Kissack, JC, 2009
)
0.35
" The primary end point was the level of sedation 1 hour after dosing on day 1, as rated by subjects using a visual analog scale (VAS) ranging from 0 = alert to 100 = drowsy."( Self-reported sedation profile of immediate-release quetiapine fumarate compared with extended-release quetiapine fumarate during dose initiation: a randomized, double-blind, crossover study in healthy adult subjects.
Berggren, L; Datto, C; Eriksson, H; Patel, JB, 2009
)
0.35
" One hour after dosing on day 1, sedation was significantly greater with quetiapine IR than with quetiapine XR (mean VAS score, 33."( Self-reported sedation profile of immediate-release quetiapine fumarate compared with extended-release quetiapine fumarate during dose initiation: a randomized, double-blind, crossover study in healthy adult subjects.
Berggren, L; Datto, C; Eriksson, H; Patel, JB, 2009
)
0.35
"Although clozapine has been shown to be the treatment of choice in people with schizophrenia that are resistant to treatment, one third to two thirds of people still have persistent positive symptoms despite clozapine monotherapy of adequate dosage and duration."( Clozapine combined with different antipsychotic drugs for treatment resistant schizophrenia.
Barbui, C; Boso, M; Cipriani, A, 2009
)
0.35
"The purpose of this article is to review the utilization and dosing of ziprasidone in a state hospital system and to compare the dosing to dosing recommendations contained in product labeling that suggest a starting dose of 40 mg/day and a target dose range of 40 to 160 mg/day for schizophrenia."( How dosing of ziprasidone in a state hospital system differs from product labeling.
Citrome, L; Jaffe, A; Levine, J, 2009
)
0.35
" If the patient is currently taking other mood stabilizers, their dosage should be optimized, and the clinician should consider adding or switching to lithium, quetiapine, or lamotrigine."( The psychopharmacology algorithm project at the Harvard South Shore Program: an update on bipolar depression.
Ansari, A; Osser, DN,
)
0.13
"Extended release quetiapine fumarate (quetiapine XR) is a new formulation that allows once-daily dosing and a titration regimen that is simpler than that of immediate release quetiapine (quetiapine IR) and may potentially increase patients' adherence to their prescribed medication."( Safety and tolerability of once-daily extended release quetiapine fumarate in acute schizophrenia: pooled data from randomised, double-blind, placebo-controlled studies.
Brecher, M; Huizar, K; Meulien, D, 2010
)
0.36
" Additional information about gender, age, co-medication and dosage was obtained."( Individual clearance and therapeutic drug monitoring of quetiapine in clinical practice.
Haen, E; Hajak, G; Hausner, H; Köstlbacher, A; Wittmann, M, 2010
)
0.36
" Further investigations are warranted to identify patient characteristics and antipsychotic dosage regimens that are not associated with a greater risk of mortality in elderly patients with dementia."( Are all commonly prescribed antipsychotics associated with greater mortality in elderly male veterans with dementia?
Dysken, MW; Lederle, FA; Rector, TS; Rossom, RC, 2010
)
0.36
" Patients [n = 493; Young Mania Rating Scale (YMRS) score >or= 20] were randomized (2:2:1) to flexibly dosed paliperidone ER (3-12 mg/day), quetiapine (400-800 mg/day), or placebo for the acute treatment phase."( A randomized, placebo- and active-controlled study of paliperidone extended release for the treatment of acute manic and mixed episodes of bipolar I disorder.
Berwaerts, J; Hough, DW; Lim, P; Nuamah, IF; Palumbo, JM; Vieta, E; Yuen, EC, 2010
)
0.36
" Patients treated with lithium or divalproex (ongoing or assigned at screening) were randomized to receive quetiapine (dosed up to 400 mg/d over 7 days, followed by 300 to 800 mg/d flexible dosing until study end) or placebo."( A double-blind, placebo-controlled study with quetiapine as adjunct therapy with lithium or divalproex in bipolar I patients with coexisting alcohol dependence.
Brown, ES; Calabrese, JR; Kotz, M; Pettinati, HM; Raines, S; Stedman, M, 2010
)
0.36
"We recommend a quick reduction of the quetiapine dosage and a change to an alternative antipsychotic for patients treated with quetiapine, who report such respiratory symptoms without a somatic cause for the symptoms."( Quetiapine-induced hyperventilation and dyspnea.
Grosshans, M; Mutschler, J; Obermann, C, 2010
)
0.36
" Medication was administered by a specialized clinical team following dosing guidelines."( Esquire trial: efficacy and adverse effects of quetiapine versus risperidone in first-episode schizophrenia.
Craig, TK; Elanjithara, T; Gafoor, R; Landau, S; McGuire, P; Power, P, 2010
)
0.36
"We report on 6 cases with partial response of psychotic positive symptoms to QTP despite sufficient dosage (mean, 783 mg/d) and serum levels (mean, 405 μg/L)."( Quetiapine combined with amisulpride in schizophrenic patients with insufficient responses to quetiapine monotherapy.
Englisch, S; Enning, F; Grosshans, M; Marquardt, L; Waltereit, R; Zink, M,
)
0.13
" Then, the medication was shifted to quetiapine at a dosage of 25 mg/d."( Effectiveness of quetiapine for poststroke pathological laughing: case report and review of the literature.
Chen, YR; Huang, YP; Kuan, TH; Lin, CH; Lin, SJ,
)
0.13
"025 mg/kg of risperidone daily for 4 months, then the dosage was doubled for another 4 months."( Post-drug consequences of chronic atypical antipsychotic drug administration on the ability to adjust behavior based on feedback in young monkeys.
Mandell, DJ; Sackett, GP; Unis, A, 2011
)
0.37
"The dose-response relationship for (immediate-release) quetiapine is established."( Relationship between daily dose, plasma concentrations, dopamine receptor occupancy, and clinical response to quetiapine: a review.
Kapur, S; Patel, MX; Sparshatt, A; Taylor, D, 2011
)
0.37
" In order to be eligible for randomization, subjects were required to prospectively fail to demonstrate an initial therapeutic response during a 4-week run-in phase with quetiapine at 600 mg/d (immediate release and dosed twice a day)."( A randomized, double-blind, parallel-group, fixed-dose, clinical trial of quetiapine at 600 versus 1200 mg/d for patients with treatment-resistant schizophrenia or schizoaffective disorder.
Citrome, L; Kaushik, S; Khan, A; Lindenmayer, JP, 2011
)
0.37
" This study attempts to elucidate the dose-response and comparative efficacy and tolerability (metabolic data) of quetiapine across psychiatric disorders."( Dose-response and comparative efficacy and tolerability of quetiapine across psychiatric disorders: a systematic review of the placebo-controlled monotherapy and add-on trials.
Dubreucq, S; Moteshafi, H; Potvin, S; Rompré, PP; Stip, E; Zhornitsky, S, 2011
)
0.37
"Quetiapine XR dosed up to 300 mg/day was generally well tolerated, with a similar profile to that of quetiapine IR."( Tolerability of extended-release quetiapine fumarate compared with immediate-release quetiapine fumarate in older patients with Alzheimer's disease with symptoms of psychosis and/or agitation: a randomised, double-blind, parallel-group study.
De Deyn, PP; Eriksson, H; Svensson, H, 2012
)
0.38
"Patients with schizophrenia or schizoaffective disorder with a body mass index ≥ 27 and non-high-density lipoprotein (non-HDL) cholesterol ≥ 130 mg/dl who were on a stable treatment dosage of olanzapine, quetiapine, or risperidone were randomly assigned to switch to ari-piprazole (N=109) for 24 weeks or stay on their current medication (N=106)."( A randomized trial examining the effectiveness of switching from olanzapine, quetiapine, or risperidone to aripiprazole to reduce metabolic risk: comparison of antipsychotics for metabolic problems (CAMP).
Hamer, RH; LaVange, LM; Lieberman, JA; McEvoy, JP; Nussbaum, AM; Perkins, DO; Ring, KD; Rosenheck, RA; Stroup, TS; Swartz, MS, 2011
)
0.37
" The numbers needed to treat to achieve an additional response over antidepressant plus placebo were 11-18 and 8-9 in the quetiapine XR 150 and 300 mg/day dosage groups, respectively."( Quetiapine extended release: adjunctive treatment in major depressive disorder.
Sanford, M, 2011
)
0.37
" Quetiapine treatment was initiated at an initial dosage of 300 mg/day."( Report of a case of steroid-induced psychosis and inappropriate sexual behaviour in an adolescent.
Demir, T; Dogangun, B; Karacetin, G; Kocabasoglu, N, 2012
)
0.38
" Propensity-stratified and propensity-weighted models as well as analyses controlling for site of care and medication dosage revealed similar patterns."( Risk of mortality among individual antipsychotics in patients with dementia.
Blow, FC; Chiang, C; Cunningham, F; Kales, HC; Kim, HM; Schneider, LS; Seyfried, LS; Valenstein, M; Zivin, K, 2012
)
0.38
" There was a dose-response relation for all drugs except quetiapine."( Differential risk of death in older residents in nursing homes prescribed specific antipsychotic drugs: population based cohort study.
Avorn, J; Crystal, S; Gerhard, T; Huybrechts, KF; Levin, R; Lucas, JA; Olfson, M; Schneeweiss, S, 2012
)
0.38
"Unmedicated individuals (n = 25) meeting DSM-IV criteria for BP-II disorder, currently depressed, were randomly assigned to weekly sessions of IPSRT (n = 14) or quetiapine (n = 11), flexibly dosed from 25-300 mg."( A randomized pilot study of psychotherapy and quetiapine for the acute treatment of bipolar II depression.
Cheng, Y; Frank, E; Swartz, HA, 2012
)
0.38
" When used for sleep, doses typically seen are less than the Food and Drug Administration-recommended dosage of 150-800 mg/day; those evaluated in the studies reviewed here were 25-200 mg/day)."( Safety of low doses of quetiapine when used for insomnia.
Coe, HV; Hong, IS, 2012
)
0.38
" There were no differences in treatment outcomes between quetiapine 300 mg/day and 600 mg/day dosage groups."( Quetiapine: a review of its use in the management of bipolar depression.
Keating, GM; Sanford, M, 2012
)
0.38
" Fifty-one female FM patients were randomized, and a flexible dosage of 50 to 300 mg/d was used."( Add-on treatment of quetiapine for fibromyalgia: a pilot, randomized, double-blind, placebo-controlled 12-week trial.
Bissonnette, A; Cloutier, C; Gendron, A; Marchand, S; Morin, M; Potvin, S, 2012
)
0.38
"Available literature points toward an early induction of hypomania or mania with low dosage of quetiapine treatment (between 100 and 400 mg/day never exceeding 600 mg/day)."( Quetiapine induced hypomania: a case report and a review of the literature.
Baddoura, C; Khalil, RB, 2012
)
0.38
" No study addressed the issue of pre-existing/concurrent psychosocial interventions, and comorbid stimulant medication and its dosage was only partially addressed."( Atypical antipsychotics for disruptive behaviour disorders in children and youths.
Hetrick, SE; Loy, JH; Merry, SN; Stasiak, K, 2012
)
0.38
" A dosage ≥400 mg/day was defined as antipsychotic."( A retrospective study of clinical usage of quetiapine XR and quetiapine IR in outpatients with schizophrenia in Denmark.
Carlborg, A; Emborg, C; Hallerbäck, T; Jörgensen, L, 2012
)
0.38
" Use in antipsychotic dosage was seen for 89% XR versus 63% IR patients (mean daily dose ≥400 mg/day; p < 0."( A retrospective study of clinical usage of quetiapine XR and quetiapine IR in outpatients with schizophrenia in Denmark.
Carlborg, A; Emborg, C; Hallerbäck, T; Jörgensen, L, 2012
)
0.38
" Further study is needed with a larger sample size, randomized controlled design and control of the dosage prescribed."( Quetiapine fumarate augmentation for patients with a primary anxiety disorder or a mood disorder: a pilot study.
Chen, CK; Chen, YC; Wang, LJ, 2012
)
0.38
"All trials were industry supported, with some variability in dosage of haloperidol."( Lower rate of depressive switch following antimanic treatment with second-generation antipsychotics versus haloperidol.
Capapey, J; Colom, F; Goikolea, JM; Grande, I; Sanchez-Moreno, J; Torres, I; Undurraga, J; Valentí, M; Vieta, E, 2013
)
0.39
"  The results support and expand previous findings that lithium should be dosed high enough to achieve plasma levels ≥0."( The association of the effect of lithium in the maintenance treatment of bipolar disorder with lithium plasma levels: a post hoc analysis of a double-blind study comparing switching to lithium or placebo in patients who responded to quetiapine (Trial 144)
Nolen, WA; Weisler, RH, 2013
)
0.39
"The use of quetiapine for treatment of bipolar disorders at a higher dosage than the licensed range is not unusual in clinical practice."( Use of high doses of quetiapine in bipolar disorder episodes are not linked to high activity of cytochrome P4503A4 and/or cytochrome P4502D6.
Bilancioni, R; Chatton, A; Eap, CB; Kaufmann, N; Khazaal, Y; Preisig, M, 2013
)
0.39
"The aim of this study was to investigate the dosing patterns of adjunctive quetiapine or adjunctive aripiprazole in the treatment of major depressive disorder from 2006 to 2010, and to evaluate the impact of Food and Drug Administration (FDA) approval on these dosing patterns."( Dosing patterns of aripiprazole and quetiapine for adjunctive treatment of major depressive disorder (2006-2010).
Forbes, RA; Guo, Z; Hebden, T; Jing, Y; Kalsekar, I; Thase, ME, 2013
)
0.39
"Participants, who were recently admitted inpatients with schizophrenia with an acute exacerbation of psychotic symptoms, were randomly assigned to 6 weeks of fixed-dose, double-blind treatment with lurasidone 80 mg (n=125), lurasidone 160 mg (n=121), quetiapine XR 600 mg (QXR-600 mg; n=119; active control included to test for assay sensitivity), or placebo (n=121), all dosed once daily in the evening."( Efficacy and safety of lurasidone 80 mg/day and 160 mg/day in the treatment of schizophrenia: a randomized, double-blind, placebo- and active-controlled trial.
Cucchiaro, J; Hsu, C; Kalali, AH; Loebel, A; Pikalov, A; Potkin, SG; Sarma, K; Xu, L, 2013
)
0.39
"To examine the effectiveness of switching patients to lurasidone using 3 different dosing strategies."( Effectiveness of lurasidone in patients with schizophrenia or schizoaffective disorder switched from other antipsychotics: a randomized, 6-week, open-label study.
Citrome, L; Cucchiaro, J; Hernandez, D; Hsu, J; Loebel, A; McEvoy, JP; Pikalov, A, 2013
)
0.39
"Adults with DSM-IV-defined schizophrenia or schizoaffective disorder in a nonacute phase of illness were randomized to 1 of 3 lurasidone dosing regimens for the initial 2 weeks of the study: (1) 40 mg/d for 2 weeks; (2) 40 mg/d for 1 week, increased to 80 mg/d on day 8 for week 2 (up-titration group); and (3) 80 mg/d for 2 weeks."( Effectiveness of lurasidone in patients with schizophrenia or schizoaffective disorder switched from other antipsychotics: a randomized, 6-week, open-label study.
Citrome, L; Cucchiaro, J; Hernandez, D; Hsu, J; Loebel, A; McEvoy, JP; Pikalov, A, 2013
)
0.39
" Once-daily dosing and simpler dose titration makes using quetiapine XR convenient for clinicians and patients."( Pharmacokinetic profile of the extended-release formulation of quetiapine fumarate (quetiapine XR): clinical implications.
Bui, K; Earley, W; Nyberg, S, 2013
)
0.39
" Elderly patients (≥66 years; DSM-IV MDD; Hamilton Rating Scale for Depression [HAM-D] total score ≥22, HAM-D Item 1 score ≥2) were randomized to quetiapine XR (flexible dosing 50-300 mg/day) or placebo."( Effects of once-daily extended release quetiapine fumarate (quetiapine XR) on quality of life and sleep in elderly patients with major depressive disorder.
Datto, C; Endicott, J; Locklear, JC; Svedsäter, H, 2013
)
0.39
" More data are needed to establish specific dosing regimens for off-label uses and to examine the dose relationship to metabolic side effects and extrapyramidal side effects to determine whether various off-label uses justify the risk incurred with using this powerful drug."( Efficacy of quetiapine off-label uses: data synthesis.
Carney, AC, 2013
)
0.39
" One-third of children and adolescents had abnormal serum triglycerides and cholesterol; however, a dose-response was not demonstrated."( Metabolic changes in first-episode early-onset schizophrenia with second-generation antipsychotics.
Amminger, GP; Becker, J; O'Donoghue, B; Papageorgiou, K; Schäfer, MR, 2014
)
0.4
" During the open-label study, quetiapine was flexibly dosed at 400-800 mg/day, with options to reduce dosing to 200 mg/day based on tolerability."( Safety, tolerability, and efficacy of quetiapine in youth with schizophrenia or bipolar I disorder: a 26-week, open-label, continuation study.
DelBello, M; Earley, WR; Findling, RL; Liu, S; Pathak, S, 2013
)
0.39
"In this 26-week study, quetiapine flexibly dosed at 400-800 mg/day, with options to reduce dosing based on tolerability, was generally safe and well tolerated in youth."( Safety, tolerability, and efficacy of quetiapine in youth with schizophrenia or bipolar I disorder: a 26-week, open-label, continuation study.
DelBello, M; Earley, WR; Findling, RL; Liu, S; Pathak, S, 2013
)
0.39
"Treatment patterns and dosing differ in patients with bipolar disorder treated with quetiapine XR compared with those treated with quetiapine IR."( Treatment patterns, healthcare resource utilization and costs in patients with bipolar disorder, newly treated with extended release or immediate release quetiapine fumarate using US healthcare administrative claims data.
Alemayehu, B; Brody, RS; Chavoshi, S; Earley, WR; Kern, D; Locklear, JC; Tunceli, O, 2013
)
0.39
"Patients who met Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) criteria for schizophrenia were randomized to 6 weeks of double-blind treatment with fixed doses of lurasidone 80 mg/d (n = 125), lurasidone 160 mg/d (n = 121), quetiapine XR 600 mg/d (n = 119), or placebo (n = 121), all dosed once daily in the evening, with food."( Daytime sleepiness associated with lurasidone and quetiapine XR: results from a randomized double-blind, placebo-controlled trial in patients with schizophrenia.
Cucchiaro, JB; Harvey, PD; Loebel, AD; Pikalov, AA; Siu, CO, 2014
)
0.4
" Other important study considerations included limited exclusion criteria to maximize generalizability, flexible dosing of APT medications to mimic real-world treatment, and an intent-to-treat analysis plan."( Clinical and Health Outcomes Initiative in Comparative Effectiveness for Bipolar Disorder (Bipolar CHOICE): a pragmatic trial of complex treatment for a complex disorder.
Bobo, WV; Bowden, CL; Calabrese, JR; Deckersbach, T; Friedman, ES; Ketter, TA; Kocsis, JH; Leon, AC; McElroy, SL; McInnis, MG; Nierenberg, AA; Reilly-Harrington, NA; Schoenfeld, D; Shelton, RC; Shesler, LW; Singh, V; Sylvia, LG; Thase, ME; Tohen, M, 2014
)
0.4
" The geometric mean elimination half-life (t ½) of both quetiapine and N-desalkyl quetiapine was consistent for the three dosing groups (approximately 7 h for quetiapine and approximately 18 h for N-desalkyl quetiapine)."( Pharmacokinetics and tolerability of extended-release quetiapine fumarate in Han Chinese patients with schizophrenia.
Chen, JX; Li, Q; Liu, Y; Si, TM; Su, YA; Tan, YL; Yang, FD, 2014
)
0.4
" In this study, a case of schizophrenia in which manic symptoms developed after increasing the dosage of quetiapine to 300 mg/day, and subsequently disappeared after cessation of treatment is presented."( [Mania associated with quetiapine treatment].
Cam, B; Gülseren, S, 2014
)
0.4
" Assessment was performed with Hamilton Depression Rating Scale (also considering clusters "core," "somatic anxiety," "psychic anxiety," "activity," and "delusion"), Hamilton Anxiety Rating Scale, Dosage Record and Treatment Emergent Symptom Scale."( Quetiapine extended release: preliminary evidence of a rapid onset of the antidepressant effect in bipolar depression.
Balzarro, B; de Ronchi, D; Porcelli, S; Serretti, A, 2014
)
0.4
" The results from the study can help inform dosing regimens in pediatrics using the quetiapine XR formulation."( Development of physiologically based pharmacokinetic model to evaluate the relative systemic exposure to quetiapine after administration of IR and XR formulations to adults, children and adolescents.
Bui, KH; Johnson, TN; Zhou, D, 2014
)
0.4
" In addition, a voxel-wise analysis of correlations between the duration of treatment or dosage and volume was also performed."( Brain differences in first-episode schizophrenia treated with quetiapine: a deformation-based morphometric study.
Bai, Y; Gao, H; Lu, W; Wu, S; Yang, C, 2015
)
0.42
" A negative correlation was observed between dosage and volume in the hippocampus, while a positive correlation was found in the caudate."( Brain differences in first-episode schizophrenia treated with quetiapine: a deformation-based morphometric study.
Bai, Y; Gao, H; Lu, W; Wu, S; Yang, C, 2015
)
0.42
" Such differences may be partially relevant to dosage and treatment duration in clinic."( Brain differences in first-episode schizophrenia treated with quetiapine: a deformation-based morphometric study.
Bai, Y; Gao, H; Lu, W; Wu, S; Yang, C, 2015
)
0.42
"This study investigated the dosing patterns of quetiapine augmentation (QA) for major depressive disorder (MDD) in routine practice."( Quetiapine augmentation for depression: dosing pattern in routine practice.
Han, C; Lee, SJ; Masand, PS; Pae, CU; Patkar, AA; Wang, SM, 2015
)
0.42
" Data were derived from a 12 week randomized double-blind study comparing flexible dosage of sertindole 12-20mg and quetiapine 400-600mg in patients with schizophrenia."( Cardiac effects of sertindole and quetiapine: analysis of ECGs from a randomized double-blind study in patients with schizophrenia.
Graff, C; Kanters, JK; Matz, J; Mittoux, A; Nielsen, J; Polcwiartek, C; Struijk, JJ; Toft, E, 2015
)
0.42
" The risk factors for treatment non-adherence include dosing frequency and complexity."( The efficacy and safety of once-daily quetiapine extended release in patients with schizophrenia switched from other antipsychotics: an open-label study in Chinese population.
Lee, MS; Pan, PY; Yeh, CB, 2015
)
0.42
" Although our study suggests the prescription dosage and duration of antipsychotic treatment decreased significantly after FDA warning in 2005, the duration of treatment was still long."( Dosage and duration of antipsychotic treatment in demented outpatients with agitation or psychosis.
Chiang, HL; Hwang, TJ; Hwu, HG; Lin, YT; Shan, JC; Sheu, YH, 2015
)
0.42
" Principal results of the study are as follows: (i) Pharmaceutically equivalent quetiapine fumarate extended release dosage form of Seroquel XR was developed using a quality by design/design of experiment (QbD/DoE) paradigm."( An understanding of modified release matrix tablets behavior during drug dissolution as the key for prediction of pharmaceutical product performance - case study of multimodal characterization of quetiapine fumarate tablets.
Dorożyński, PP; Haznar-Garbacz, D; Kulinowski, P; Rappen, GM; Węglarz, WP; Woyna-Orlewicz, K, 2015
)
0.42
" Due to the simple dosing regimen of QUE-XR, conducting therapy with this drug may contribute to the improvement of compliance."( [The place of quetiapine extended release in the treatment of mental disorders].
Datka, W; Drozdowicz, K; Dudek, D; Jaeschke, R; Siwek, M; Styczeń, K,
)
0.13
" The enzyme activity varied according to the dose, brain region, and acute or chronic dosing protocols."( Acute and Chronic Treatments with Quetiapine Increase Mitochondrial Respiratory Chain Complex Activity in the Rat Brain.
Abelaira, HM; Bruchchen, L; Carlessi, AS; Carvalho-Silva, M; da Luz, JR; Gomes, LM; Ignácio, ZM; Matias, BI; Quevedo, J; Rebelo, J; Réus, GZ; Streck, EL; Titus, SE, 2015
)
0.42
" There was no support for a dose-response relationship for any drug combination."( Skating on thin ice: pragmatic prescribing for medication refractory schizophrenia.
Joyce, DW; Mateos Fernandez, MJ; Sarkar, SN; Shergill, SS; Tracy, DK, 2015
)
0.42
" Treatment with 20% acetylcysteine oral solution was initiated at a dosage of 600 mg twice daily as an adjunct to quetiapine therapy."( Acetylcysteine for treatment of autism spectrum disorder symptoms.
Dopheide, J; Stutzman, D, 2015
)
0.42
" Moreover, available tools that guide dosing in neuropsychiatric pediatric patients are scant, leading to the possibility of reduced efficacy and/or increased risks of toxicity."( Therapeutic drug monitoring of second-generation antipsychotics in pediatric patients: an observational study in real-life settings.
Auricchio, F; Baldelli, S; Bernardini, R; Bertella, S; Bravaccio, C; Capuano, A; Carnovale, C; Cattaneo, D; Clementi, E; Ferrajolo, C; Fucile, S; Guastella, G; Mani, E; Molteni, M; Pascotto, A; Pisano, S; Pozzi, M; Radice, S; Rafaniello, C; Riccio, MP; Rizzo, R; Rossi, F; Scuderi, MG; Sperandeo, S; Sportiello, L; Villa, L, 2016
)
0.43
" Next, monkeys were treated with quetiapine (25 mg, by mouth, twice a day) for approximately 30 days, and then the quetiapine self-administration dose-response curve was redetermined."( Evaluation of the Reinforcing Effect of Quetiapine, Alone and in Combination with Cocaine, in Rhesus Monkeys.
Brutcher, RE; Nader, MA; Nader, SH, 2016
)
0.43
" The development of an in vitro-in vivo correlation (IVIVC) and the use of in vitro data to predict in vivo bioavailability parameters has been of great interest for the rational development and evaluation process for extended release dosage forms."( Development of a level A in vitro-in vivo correlation for extended release dosage forms of quetiapine fumarate.
Gonçalves de Lima, L; Rossi de Campos, D, 2016
)
0.43
" Analyses were conducted assuming pooled dosing from randomised clinical trials included in the MTCs."( Cost-effectiveness Analysis of Aripiprazole Once-Monthly for the Treatment of Schizophrenia in the UK.
Beillat, M; Robinson, P; Sapin, C; Tempest, M; Treur, M, 2015
)
0.42
" There are currently no studies evaluating non-oral compounded dosage forms of quetiapine."( A Single-Dose Crossover Pharmacokinetic Comparison Study of Oral, Rectal and Topical Quetiapine in Healthy Adults.
Bobo, WV; Cunningham, JL; Dierkhising, RA; Kung, S; Lapid, MI; Leung, JG; Nelson, S; Plevak, MF; Thompson, VH, 2016
)
0.43
" When detected, serum levels achieved with topical quetiapine were delayed and low in comparison with those produced by the oral and rectal dosage forms."( A Single-Dose Crossover Pharmacokinetic Comparison Study of Oral, Rectal and Topical Quetiapine in Healthy Adults.
Bobo, WV; Cunningham, JL; Dierkhising, RA; Kung, S; Lapid, MI; Leung, JG; Nelson, S; Plevak, MF; Thompson, VH, 2016
)
0.43
" bolus dosing of nonencapsulated drug (FQ) and QLNC formulations alone and in association with probenecid to male Wistar rats."( Pharmacokinetic Investigation of Quetiapine Transport across Blood-Brain Barrier Mediated by Lipid Core Nanocapsules Using Brain Microdialysis in Rats.
Carreño, F; Dalla Costa, T; Guterres, SS; Paese, K; Silva, CM, 2016
)
0.43
" These results indicate that higher doses of these drugs could lead to greater QT prolongation in a dose-response manner."( A thorough QT study to evaluate the QTc prolongation potential of two neuropsychiatric drugs, quetiapine and escitalopram, in healthy volunteers.
Cho, JY; Chung, H; Chung, JY; Jang, IJ; Kim, A; Lee, H; Lim, KS; Yoon, SH; Yu, KS, 2016
)
0.43
" The interpretation based on the simulations does not call for a genotype-based dosing scheme and is consistent with consensus guidelines for quetiapine that therapeutic drug monitoring is considered useful."( Quantitation of the impact of CYP3A5 A6986G polymorphism on quetiapine pharmacokinetics by simulation of target attainment.
Derendorf, H; Melhem, M; Shilbayeh, SA; Sy, SK; Zmeili, R, 2015
)
0.42
" Quetiapine was used in all studies with a bedtime dosage between 50 and 300 mg/day."( Antipsychotics for fibromyalgia in adults.
Häuser, W; Klose, P; Phillips, T; Üçeyler, N; Walitt, B, 2016
)
0.43
" This open-label, parallel-group study was performed to compare finger-stick-based capillary with corresponding venous plasma concentrations for risperidone, paliperidone, quetiapine, olanzapine, and aripiprazole and their major metabolites after repeated dosing in patients with schizophrenia or related illnesses."( Comparison of Capillary and Venous Plasma Drug Concentrations After Repeated Administration of Risperidone, Paliperidone, Quetiapine, Olanzapine, or Aripiprazole.
Ariyawansa, J; De Meulder, M; Remmerie, B; Savitz, A, 2016
)
0.43
"After a 1-week placebo run-in, quetiapine was started at a daily dosage of 25 mg and increased to a maximum of 800 mg; the average was 258 mg (range, 50-800 mg)."( Efficacy of Quetiapine Monotherapy in Posttraumatic Stress Disorder: A Randomized, Placebo-Controlled Trial.
Calais, LA; Cañive, JM; Durklaski, V; Hamner, MB; Qualls, C; Robert, S; Villarreal, G; Zhai, Y, 2016
)
0.43
" Despite estimates being robust following sensitivity analyses, limitations include the potential for residual confounding and ascertainment bias and an inability to examine dosage effects."( Adverse Renal, Endocrine, Hepatic, and Metabolic Events during Maintenance Mood Stabilizer Treatment for Bipolar Disorder: A Population-Based Cohort Study.
Geddes, JR; Hayes, JF; King, M; Marston, L; Osborn, DP; Walters, K, 2016
)
0.43
" This study aims at designing a novel dosage form of sustained release taste-masked QT orally disintegrating tablets (ODTs) based on solid lipid micro-pellets (SLMPs)."( A dual strategy to improve psychotic patients' compliance using sustained release quetiapine oral disintegrating tablets.
Boraei, N; Ismail, F; Refaat, A; Sokar, M, 2016
)
0.43
" However, acute hyperglycemic effect was detected only after dosing of the drug at the beginning of an active phase."( Effect of a dosing-time on quetiapine-induced acute hyperglycemia in mice.
Ando, H; Fujimura, A; Fujiwara, Y; Hosohata, K; Kapse, S; Kitamura, H; Kotani, K; Shimba, S; Suzuki, C; Ushijima, K, 2017
)
0.46
"4β-Hydroxycholesterol (4βOHC) is sensitive towards induction or inhibition of CYP3A4, but its potential usefulness as a dosing biomarker remains to be demonstrated."( 4β-Hydroxycholesterol level significantly correlates with steady-state serum concentration of the CYP3A4 substrate quetiapine in psychiatric patients.
Andreassen, OA; Gjestad, C; Haslemo, T; Molden, E, 2017
)
0.46
" This supports the potential usefulness of 4βOHC as a phenotype biomarker for individualized dosing of quetiapine and other drugs where systemic exposure is mainly determined by CYP3A4 metabolism."( 4β-Hydroxycholesterol level significantly correlates with steady-state serum concentration of the CYP3A4 substrate quetiapine in psychiatric patients.
Andreassen, OA; Gjestad, C; Haslemo, T; Molden, E, 2017
)
0.46
"The median daily dosage of quetiapine was 300mg (Q1: 300mg, Q3: 600mg, range 200-800mg)."( Pregnancy exposure to quetiapine - Therapeutic drug monitoring in maternal blood, amniotic fluid and cord blood and obstetrical outcomes.
Augustin, M; Goecke, TW; Gründer, G; Kuzin, M; Paulzen, M; Schoretsanitis, G, 2018
)
0.48
" A significant positive correlation was observed between estimated daily dosage of quetiapine and average concentration in hair for individuals with natural hair colour (p=0."( Post-mortem quetiapine concentrations in hair segments of psychiatric patients - Correlation between hair concentration, dose and concentration in blood.
Banner, J; Günther, KN; Johansen, SS; Linnet, K; Nielsen, MKK; Wicktor, P, 2018
)
0.48
" The duration of each adequate antipsychotic treatment at an optimal dosage was 4 weeks or more."( Predictors of remission during acute treatment of first-episode schizophrenia patients involuntarily hospitalized and treated with algorithm-based pharmacotherapy: Secondary analysis of an observational study.
Sakamoto, S; Sato, K; Takaki, M; Yamada, N; Yoshimura, B, 2019
)
0.51
" There were no differences in first-line antipsychotics, dosage of antipsychotics at time of response and adherence rates to algorithm-based pharmacotherapy between remitters and non-remitters."( Predictors of remission during acute treatment of first-episode schizophrenia patients involuntarily hospitalized and treated with algorithm-based pharmacotherapy: Secondary analysis of an observational study.
Sakamoto, S; Sato, K; Takaki, M; Yamada, N; Yoshimura, B, 2019
)
0.51
"Although current quetiapine labeling recommends that its dosage should be lowered 6-fold when coadministered with strong cytochrome P450 (CYP)3A inhibitors, a reported case of coma in a patient receiving quetiapine with lopinavir and ritonavir prompted the reevaluation of labeling recommendations for the dosing of quetiapine when coadministered with human immunodeficiency virus (HIV) protease inhibitors."( Dosing Recommendations for Quetiapine When Coadministered With HIV Protease Inhibitors.
Cao, KY; Gish, PL; Hyon, K; Mishra, P; Sampson, MR; Tauber, W; Younis, IR; Zhao, P; Zhou, EH, 2019
)
0.51
" Hence, a different dosing strategy is required among smoking and nonsmoking patients."( Analysis of smoking behavior on the pharmacokinetics of antidepressants and antipsychotics: evidence for the role of alternative pathways apart from CYP1A2.
Deckert, J; Hommers, LG; Menke, A; Samanski, L; Scherf-Clavel, M; Unterecker, S, 2019
)
0.51
"During a period of inflammation in patients taking quetiapine, according to our results, attention in dosing strategies is required to prevent toxic plasma concentrations."( Pathological Concentration of C-reactive Protein is Correlated to Increased Concentrations of Quetiapine, But Not of Risperidone, Olanzapine and Aripiprazole in a Naturalistic Setting.
Deckert, J; Menke, A; Scherf-Clavel, M; Unterecker, S; Weidner, A, 2020
)
0.56
"The aim of this study was to investigate time trends in dosing and prevalence of antipsychotic prescriptions in Scandinavia."( Trends in utilization and dosing of antipsychotic drugs in Scandinavia: Comparison of 2006 and 2016.
Correll, CU; Højlund, M; Johnsen, E; Kroken, RA; Munk-Jørgensen, P; Pottegård, A; Reutfors, J, 2019
)
0.51
"Using patient-derived glioblastoma stem cell (GSC) cultures from 15 GBM patients, we described stem cell properties of individual cultures, determined the dose-response relationships of the drugs in the CUSP9, and assessed the efficacy the CUSP9 combination with TMZ in concentrations clinically achievable."( The efficacy of a coordinated pharmacological blockade in glioblastoma stem cells with nine repurposed drugs using the CUSP9 strategy.
Grieg, Z; Langmoen, IA; Sandberg, CJ; Skaga, E; Skaga, IØ; Vik-Mo, EO, 2019
)
0.51
"8 points), quetiapine dosage (-150 mg), blood pressure (-2."( An Indoor Therapeutic Garden for Behavioral Symptoms in Alzheimer's Disease: A Randomized Controlled Trial.
Brasioli, A; Fonte, C; Muti, E; Pedrinolla, A; Schena, F; Smania, N; Sollima, A; Tamburin, S; Venturelli, M, 2019
)
0.51
" Particularly, impact associated with dosage has been barely studied."( Effects of long-term antipsychotics treatment on body weight: A population-based cohort study.
Bazo-Alvarez, JC; Carpenter, JR; Hayes, JF; Morris, TP; Petersen, I, 2020
)
0.56
"The dose-response relationships of antipsychotic drugs for schizophrenia are not well defined, but such information would be important for decision making by clinicians."( Dose-Response Meta-Analysis of Antipsychotic Drugs for Acute Schizophrenia.
Crippa, A; Davis, JM; Leucht, S; Orsini, N; Patel, MX; Siafis, S, 2020
)
0.56
" Dose-response curves were constructed with random-effects dose-response meta-analyses and a spline model."( Dose-Response Meta-Analysis of Antipsychotic Drugs for Acute Schizophrenia.
Crippa, A; Davis, JM; Leucht, S; Orsini, N; Patel, MX; Siafis, S, 2020
)
0.56
" For some drugs, higher than currently licensed doses might be tested in further trials, because their dose-response curves did not plateau."( Dose-Response Meta-Analysis of Antipsychotic Drugs for Acute Schizophrenia.
Crippa, A; Davis, JM; Leucht, S; Orsini, N; Patel, MX; Siafis, S, 2020
)
0.56
" This study applied pharmacokinetic modelling principles to investigate the mechanism of these changes and to propose new dosing strategies to counteract these changes."( Quetiapine dose optimisation during gestation: a pharmacokinetic modelling study.
Badhan, RKS; Macfarlane, H, 2020
)
0.56
" A dosing optimisation strategy identified that dose increases to 500-700 mg twice daily would result in 32-55% of subjects possessing trough concentration in excess of 50 ng/ml."( Quetiapine dose optimisation during gestation: a pharmacokinetic modelling study.
Badhan, RKS; Macfarlane, H, 2020
)
0.56
" We used the Generalized Propensity Score method to evaluate the dose-response risk of Parkinsonism associated with SGAs."( Comparative risk of Parkinsonism associated with olanzapine, risperidone and quetiapine in older adults-a propensity score matched cohort study.
Chyou, TY; Nishtala, PS; Nishtala, R, 2020
)
0.56
" It is not possible to put a temporal period for each segment, as the hair growth at the age of 32 months is not the same as for an adult (difference in the duration of the anagen period), nor to put any quantitative dosage or frequency of exposure(s) when interpreting the data."( The Difficult Interpretation of a Hair Test Result from a 32-Month-Old Child: Administration of Propranolol and Quetiapine or Contamination?
Ameline, A; Kintz, P; Raul, JS, 2020
)
0.56
" Dosing recommendations however are often based on strategies used in patients with normal body habitus."( Drug dosing in the critically ill obese patient-a focus on sedation, analgesia, and delirium.
Barletta, JF; Erstad, BL, 2020
)
0.56
" Remission from SW/SRE was noted in all cases with measures including antipsychotic dosage reduction, discontinuation of medication, switching to an alternate medication, and use of continuous positive airway pressure (CPAP) for comorbid obstructive sleep apnea (OSA) treatment."( Sleepwalking and sleep-related eating associated with atypical antipsychotic medications: Case series and systematic review of literature.
Baliga, N; Chopra, A; Das, P; Narahari, A; Patel, RS,
)
0.13
"To determine if adjunctive use of quetiapine reduces sedative dosage requirements among mechanically ventilated adults without delirium."( Effectiveness of Quetiapine as a Sedative Adjunct in Mechanically Ventilated Adults Without Delirium.
Cox, CE; Gilstrap, DL; Kram, BL; Kram, SJ; Ohman, KL; Schultheis, JM; Yang, Z, 2021
)
0.62
" The primary outcome was the change in sedative dosage requirements over 24 hours following quetiapine initiation."( Effectiveness of Quetiapine as a Sedative Adjunct in Mechanically Ventilated Adults Without Delirium.
Cox, CE; Gilstrap, DL; Kram, BL; Kram, SJ; Ohman, KL; Schultheis, JM; Yang, Z, 2021
)
0.62
"Adjunctive use of quetiapine was not associated with a significant reduction in sedative dosage requirements 24 or 48 hours following initiation among mechanically ventilated adults without delirium."( Effectiveness of Quetiapine as a Sedative Adjunct in Mechanically Ventilated Adults Without Delirium.
Cox, CE; Gilstrap, DL; Kram, BL; Kram, SJ; Ohman, KL; Schultheis, JM; Yang, Z, 2021
)
0.62
" Regression and dose-response models were utilized to identify the threshold dose (maximum daily dose)."( Discontinuation of antipsychotics treatment for elderly patients within a specialized behavioural unit: a retrospective review.
Gao, RL; Lim, KS; Luthra, AS, 2021
)
0.62
" An optimized dose-response curve is then presented, introducing (±) amphetamine hydrochloride (0."( A Molecularly Imprinted Polymer-based Dye Displacement Assay for the Rapid Visual Detection of Amphetamine in Urine.
Arreguin-Campos, R; Caldara, M; Cleij, TJ; Diliën, H; Eersels, K; Heidt, B; Jimenez-Monroy, KL; Lowdon, JW; Rogosic, R; van Grinsven, B, 2020
)
0.56
" The dose-response association was further analysed by 3 quetiapine doses: low (≤<=0."( Dose-response association of acute-phase quetiapine treatment with risk of new-onset hypothyroidism in schizophrenia patients.
Li, M; Retnakaran, R; Sun, Z; Wen, SW; Yuan, X; Zhai, D; Zhang, R; Zhao, Y, 2021
)
0.62
"Acute phase quetiapine treatment for schizophrenia patients was strongly associated with increased risk of developing new-onset hypothyroidism, with a clear dose-response association."( Dose-response association of acute-phase quetiapine treatment with risk of new-onset hypothyroidism in schizophrenia patients.
Li, M; Retnakaran, R; Sun, Z; Wen, SW; Yuan, X; Zhai, D; Zhang, R; Zhao, Y, 2021
)
0.62
" For the treatment of pediatric populations or patient populations with trouble swallowing tablets, an oral suspension would be an ideal dosage formulation."( The stability of quetiapine oral suspension compounded from commercially available tablets.
Deville, R; Dong, X; Evans, J; Gervase, MA; Tran, J, 2021
)
0.62
" A dose-response association between quetiapine exposure and decline in TSH index and TFQI was observed (P < 0."( Impaired central set point of thyroid homeostasis during quetiapine treatment in the acute phase of schizophrenia.
Guan, Q; Han, J; Hao, W; Huang, X; Retnakaran, R; Shi, J; Sun, J; Wang, Q; Wen, SW; Yang, J; Zhai, D; Zhang, R; Zhang, X; Zhao, Y, 2022
)
0.72
"Quetiapine was associated with TSH index and TFQI reduction in a dose-response pattern, suggesting that impaired central set point may be involved in the mechanism by which quetiapine affects hypothalamus-pituitary-thyroid axis in acute phase schizophrenia patients."( Impaired central set point of thyroid homeostasis during quetiapine treatment in the acute phase of schizophrenia.
Guan, Q; Han, J; Hao, W; Huang, X; Retnakaran, R; Shi, J; Sun, J; Wang, Q; Wen, SW; Yang, J; Zhai, D; Zhang, R; Zhang, X; Zhao, Y, 2022
)
0.72
" The proportion of patients dosed above the new limit decreased from 8 to 1% in patients ≤ 65 years and from 46 to 23% in patients > 65 years old for citalopram versus 14-5% and 47-31% for escitalopram."( Dear Doctor Letters regarding citalopram and escitalopram: guidelines vs real-world data.
Bleich, S; Bridler, R; de Bardeci, M; Greil, W; Grohmann, R; Hasler, G; Kasper, S; Köberle, U; Rüther, E; Seifert, J; Stassen, H; Toto, S; Willms, J, 2023
)
0.91
"The effects of antipsychotic drugs are dose-dependent, which is particularly true for their efficacy, each antipsychotic having a specific dose-response curve."( Comorbidities and the right dose: antipsychotics.
Azorin, JM; Simon, N; Torrents, R,
)
0.13
"Factors liable to impact antipsychotic dosage are numerous and their subsequent effects often hard to predict, due to multilevel interactions and compensatory phenomena."( Comorbidities and the right dose: antipsychotics.
Azorin, JM; Simon, N; Torrents, R,
)
0.13
" No known medication dosage increases had been made, nor had any new serotonergic agents been added to the patient's drug regimen."( A 70-Year-Old Woman Presenting with Confusion and Muscle Spasms Due to Serotonin Syndrome Associated with Paroxetine and Quetiapine Treatment.
Mostel, E; Patel, S; Wiener, BG, 2022
)
0.72
"54]) subgroups, at the dosage of 50 mg (SMD: -0."( Effects of quetiapine on sleep: A systematic review and meta-analysis of clinical trials.
Chiang, CH; Lin, CY; Loh, EW; Tam, KW; Tseng, MM, 2023
)
0.91
" The present study reviews analytical methods with their validation parameters published during the last 22 years (1999-2021) either as a single entity or combination in dosage form, and determination from biological samples."( Quetiapine Fumarate: A Review of Analytical Methods.
Hamsa, A; Kariyarambath, P; Karumandampalayam Shanmugaramasamy, K; Kathirvel, S, 2023
)
0.91
" Potential dosage effects were examined in a 3 × 1 ANOVA."( Treatment with the second-generation antipsychotic quetiapine is associated with increased subgenual ACC activation during reward processing in major depressive disorder.
Bauer, J; Borgers, T; Dannlowski, U; Dohm, K; Enneking, V; Goltermann, J; Grotegerd, D; Klug, M; Kraus, A; Kugel, H; Leehr, EJ; Omlor, N; Opel, N; Redlich, R; Repple, J; Richter, M; Steinmann, LA, 2023
)
0.91
" We applied one-stage random-effects dose-response meta-analyses using restricted cubic splines to model the dose-response relationships."( Antipsychotic-induced akathisia in adults with acute schizophrenia: A systematic review and dose-response meta-analysis.
Burschinski, A; Davis, JM; Leucht, S; Priller, J; Schneider-Thoma, J; Siafis, S; Wang, D; Wu, H, 2023
)
0.91
"We hypothesized that QTP-IR is inferior to QTP-ER at any dose in efficacy for the acute treatment in schizophrenia and tested using a dose-response model-based network meta-analysis (NMA)."( Comparative efficacy of quetiapine by dose and formulation for psychosis in schizophrenia: A systematic review and dose-response model-based network meta-analysis.
Fukushima, H; Terao, I; Yokoi, A, 2023
)
0.91
" A random effect Bayesian dose-response model-based NMA was performed to compare the dose-response relationships between QTP-IR and QTP-ER."( Comparative efficacy of quetiapine by dose and formulation for psychosis in schizophrenia: A systematic review and dose-response model-based network meta-analysis.
Fukushima, H; Terao, I; Yokoi, A, 2023
)
0.91
" Current research revealed the successful development of intranasal QF-Nanoemulgel as a novel dosage form for the safe and effective delivery of QF in schizophrenia patients."( A Nanoemulgel for Nose-to-Brain delivery of Quetiapine - QbD-Enabled formulation development & in-vitro characterization.
Gadhave, D; Goyal, M; Gupta, V; Quadros, M; Ugale, AR, 2023
)
0.91
" By varying fatty acid chain length, the enzyme-oriented QTP controlled release dosage form was challenged to enhance the therapeutic effectiveness of QTP."( Roles of Fatty Acid Chain Length and Enzyme-Oriented Drug Controlled Release from pH-Triggering Self-Assembled Fatty Acid Conjugated Quetiapine Nanosuspensions.
Gil, MC; Lee, BJ; Ngo, HV; Nguyen, HD; Nguyen, VH, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Drug Classes (1)

ClassDescription
fumarate saltAn organic salt derived from fumaric acid.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Research

Studies (2,925)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's98 (3.35)18.2507
2000's1222 (41.78)29.6817
2010's1244 (42.53)24.3611
2020's361 (12.34)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials619 (19.58%)5.53%
Reviews479 (15.15%)6.00%
Case Studies826 (26.12%)4.05%
Observational29 (0.92%)0.25%
Other1,209 (38.24%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (371)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Neurocognitive Effectiveness in Treatment of First-episode Non-affective Psychosis: a Randomized Comparison of Aripiprazole, Quetiapine and Ziprasidone Over 1 Year [NCT02534363]Phase 4136 participants (Actual)Interventional2005-10-31Completed
Tolerance and Effect of Antipsychotics in Children and Adolescents With Psychosis- An Investigator-initiated, Phase IV, Randomised Double-blind Multi-centre Trial of the Benefits and Harms of Aripiprazole Versus Quetiapine in Children and Adolescents With [NCT01119014]Phase 4300 participants (Anticipated)Interventional2010-05-31Active, not recruiting
[NCT01587066]Phase 40 participants (Actual)Interventional2010-08-31Withdrawn
Phase IV Study of Effectiveness of Aripiprazole, Quetiapine, and Ziprasidone in the Treatment of First Episode of Non-affective Psychosis Individuals Included in the First Episode Psychosis Clinical Program II (PAFIP II): a 3-year Follow-up [NCT02526030]Phase 4203 participants (Actual)Interventional2008-10-31Completed
A Twelve-Month, Prospective, Randomized, Active-Controlled, Open-Label, Flexible-Dose Study of Paliperidone Palmitate Compared With Oral Antipsychotic Treatment in Adults With Schizophrenia Who Have Been Recently Discharged From an Inpatient Psychiatric H [NCT01193166]Phase 40 participants (Actual)Interventional2010-08-31Withdrawn(stopped due to This study was stopped due to an internal reconsideration of priorities of the product portfolio.)
Efficacy of Quetiapine XR vs. Placebo as Concomitant Treatment to Mood Stabilizers in the Control of Subsyndromal Symptoms of Bipolar Disorder [NCT01197846]Phase 328 participants (Actual)Interventional2010-09-30Completed
A Pilot Randomized, Double-blind, Placebo-controlled Study to Evaluate Safety and Daytime Sedation in Subjects With Parkinson's Disease With Neuropsychiatric Symptoms Treated With Pimavanserin or Low-Dose Quetiapine [NCT04164758]Phase 211 participants (Actual)Interventional2019-10-23Terminated(stopped due to Study enrollment impacted by COVID-19 pandemic and Sponsor terminated for business reasons)
A Multicentre, 8-week, Single-arm, Open-label, Pragmatic Trial to Explore Acceptance and Performance of Using a Digital Medicine System With Healthcare Professionals and Adult Subjects With Schizophrenia, Schizoaffective Disorder, or First Episode Psychos [NCT03568500]Phase 444 participants (Actual)Interventional2018-05-21Completed
Functional Reciprocity Between Heightened Stress Reactivity and Emotional Numbing in PTSD: Novel Predictors of Pharmacotherapeutic Outcomes [NCT01066156]34 participants (Actual)Interventional2010-02-28Completed
Phase IV Study of Effects of 'Seroquel-XR' on the Improvement of Neurocognitive Function in People At-risk Mental States(ARMS) [NCT01250847]Phase 483 participants (Anticipated)Interventional2010-11-30Recruiting
Chinese Longitudinal and Systematic Study of Bioplar Disorder [NCT05480150]10,000 participants (Anticipated)Interventional2021-11-01Recruiting
Controlled, Double-blind, Randomized Clinical Trial for Prophylaxis of Postoperative Delirium in High Risk Surgical Patients With Quetiapine [NCT03739476]Phase 350 participants (Actual)Interventional2019-02-13Terminated(stopped due to Due to the crisis SARS-COV-2 pandemic: recruitment of patients for the trial is stopped, healthcare pressure generated, suspend the non-essential scheduled surgical activity and on June 30, 2020 medication expired, funding has been exhausted.)
An Observational Drug Utilization Study of SYCREST^® (Asenapine) in the United Kingdom [NCT01498770]42 participants (Actual)Observational2013-04-01Completed
Open-Label Study of Quetiapine for Mania In Preschool Children 4 to 6 Years of Age With Bipolar and Bipolar Spectrum Disorder [NCT00181883]Phase 430 participants (Actual)Interventional2005-02-28Completed
The Effect of Quetiapine XR in Depressive Patients Showing Aberrant N100 Amplitude Slope [NCT01357967]Phase 460 participants (Anticipated)Interventional2011-05-31Recruiting
Effectiveness of Antipsychotic Drugs to Treat Psychosis Syndrome: an Open Label, Controlled Study [NCT02137616]300 participants (Anticipated)Interventional2012-06-30Recruiting
A Phase 1, 2-Part, Open-Label, Randomized, Crossover Pilot Trial to Assess the Relative Bioavailability of Quetiapine Versus Seroquel® 300-mg Oral Tablets in Subjects With Schizophrenia or Bipolar Disorder and 25-mg Oral Tablets in Healthy Subjects [NCT03872596]Phase 158 participants (Actual)Interventional2019-03-27Completed
Effects of Seroquel XR (Quetiapine Fumarate Extended-Release) on Sleep Architecture in Patients With Major Depressive Disorder [NCT01189318]Phase 20 participants (Actual)Interventional2012-03-31Withdrawn
A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR) in the Treatment of Elderly Patients With Major Depressive Disorder [NCT00388973]Phase 3338 participants (Actual)Interventional2006-09-30Completed
Effects of Quetiapine on Sleep and Next Day Alertness in People With Obstructive Sleep Apnea [NCT05303935]Phase 215 participants (Actual)Interventional2022-05-25Completed
Changes of Heart Rate Variability in Schizophrenic and Bipolar Patients Under the Medication of Aripiprazole and Quetiapine [NCT01047215]Phase 4120 participants (Anticipated)Interventional2009-08-31Recruiting
A Randomized Trial Comparing Efficacy and Tolerability of Levomilnacipran Switch Versus Adjunctive Quetiapine in Major Depressive Disorder (MDD) With Inadequate Response to SSRIs [NCT02720198]Phase 360 participants (Actual)Interventional2017-01-23Completed
A Randomized, Multi-site, Parallel-group, Rater-blind Study Comparing Response With Aripiprazole Once Monthly and Standard of Care Oral Antipsychotics in Non-adherent Outpatients With Schizophrenia Identified Using the Brief Adherence Rating Scale [NCT02282085]Phase 4200 participants (Anticipated)Interventional2014-12-31Recruiting
Neuroendocrine, Metabolite Substrates, Clinical Symptoms and Cognitive Function in Schizophrenia [NCT02423096]200 participants (Anticipated)Observational [Patient Registry]2013-12-31Recruiting
[NCT02297763]Phase 3194 participants (Anticipated)Interventional2015-03-31Not yet recruiting
Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Quetiapine-Referenced, Fixed-Dose Study of Lu AA39959 in the Treatment of Depression in Patients With Bipolar I or II Disorder [NCT00771134]Phase 2105 participants (Actual)Interventional2008-12-31Terminated(stopped due to Study was previously suspended and is now terminated)
Pharmacotherapy of Generalized Anxiety Disorder With Seroquel: Normalization of Brain Stress and Reward Function [NCT01066143]8 participants (Actual)Interventional2010-02-28Terminated(stopped due to The underwriter stopped the funding)
Serotonin Transporter Genetic Variation and Amygdala Responses to Quetiapine and Selective Serotonin Reuptake Inhibitor Treatment in Major Depression [NCT02132286]Phase 457 participants (Actual)Interventional2008-12-31Completed
A Long-Term, Open-Label, Multicenter Study of LY2140023 Compared to Atypical Antipsychotic Standard of Care in Patients With DSM-IV-TR Schizophrenia [NCT01129674]Phase 2/Phase 31,210 participants (Anticipated)Interventional2010-06-30Terminated(stopped due to The decision to stop the trial was based on efficacy results in the overall schizophrenia participant population.)
A Dose-finding, Safety and Tolerability Trial of Extended-release Quetiapine in Relapsing-remitting and Progressive Multiple Sclerosis [NCT02087631]Phase 1/Phase 214 participants (Actual)Interventional2014-12-31Completed
A Single Dose Pharmacokinetic Study of Topical and Rectal Quetiapine Compared to Oral Quetiapine in Healthy Adults [NCT02131545]Phase 110 participants (Actual)Interventional2014-06-30Completed
Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics for the Prevention of Relapse in Long-term Stabilized Schizophrenic Patients: a Randomized, Single-blind, Longitudinal Trial [NCT02307396]Phase 421 participants (Actual)Interventional2015-02-01Completed
Combination of Paroxetine CR and Quetiapine for the Treatment of Refractory Generalized Anxiety Disorder [NCT00113295]Phase 450 participants (Actual)Interventional2004-02-29Completed
Risk and Protective Factors for SGA-induced Metabolic Syndrome in Bipolar Youth [NCT01858948]Phase 319 participants (Actual)Interventional2013-07-31Completed
A Randomised, Double-Blind, Parallel-Group, Flexible-Dose Study Exploring the Neurocognitive Effect of Sertindole Versus Comparator in Patients With Schizophrenia Using the MATRICS Consensus Cognitive Battery (MCCB) [NCT00654706]Phase 3264 participants (Actual)Interventional2008-03-31Completed
A Randomized, Open-label, Rater-Blinded, Active-Controlled, International, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Flexibly Dosed Esketamine Nasal Spray Compared With Quetiapine Extended-Release in Adult and Elderly Partici [NCT04338321]Phase 3676 participants (Actual)Interventional2020-08-21Completed
A Double-Blind, Placebo-Controlled, Flexible-Dosage Study to Evaluate the Efficacy and Safety of Adjunctive Quetiapine in the Treatment of Refractory Social Anxiety Disorder in Adults [NCT01224067]Phase 440 participants (Anticipated)Interventional2006-03-31Completed
A Multi-Centre, Double-Blind, Randomised, Parallel Group, Escitalopram Controlled Phase III-B Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR TM) as Monotherapy in the Treatment of Adult Patients With Agitated Major D [NCT01363310]Phase 3250 participants (Anticipated)Interventional2010-10-31Terminated(stopped due to Termination of sponsorship)
A Prospective, Matched-Control, Randomized, Open-Label, Flexible-Dose, Study in Subjects With Recent-Onset Schizophrenia or Schizophreniform Disorder to Compare Disease Progression and Disease Modification Following Treatment With Paliperidone Palmitate L [NCT02431702]Phase 3337 participants (Actual)Interventional2015-07-08Completed
Quetiapine in Melancholic Depression: an fMRI Study of Treatment-induced Changes in the Neurocircuitry of the Stress Response [NCT01200901]Phase 420 participants (Actual)Interventional2008-09-30Completed
Exploring Alterations of Central Autonomic Modulation in Patients With Bipolar Depression [NCT01213121]Phase 460 participants (Anticipated)Interventional2010-09-30Recruiting
Clinical Effectiveness Of The Newer Antipsychotic Compounds Olanzapine, Quetiapine And Aripiprazole In Comparison With Low Dose Conventional Antipsychotics (Haloperidol And Flupentixol) In Patients With Schizophrenia [NCT01164059]Phase 4149 participants (Actual)Interventional2010-02-28Completed
Continuation Electroconvulsive Therapy Associated With Pharmacotherapy Versus Pharmacotherapy Alone for Relapse Prevention in Major Depression. A Clinical, Controlled, Prospective and Randomized Trial [NCT01305707]Phase 4104 participants (Actual)Interventional2009-07-31Terminated(stopped due to Difficulties in recruiting)
Bioequivalence Study of Quetiapine in Healthy Volunteers, After Administering a Single Dose of the Test Extended Release Formulation, Kemoter XR With Respect to the Reference Product, Etiasel XR ® From AstraZeneca S.A. [NCT03317236]Phase 424 participants (Actual)Interventional2017-03-13Completed
Randomised, Double-blind, Parallel-group, Placebo-controlled, and Active Referenced Study of Lu AA34893 to Evaluate the Efficacy and Safety of Three Doses Lu AA34893 in the Treatment of Depression in Patients With Bipolar I or II Disorder [NCT00622245]Phase 2166 participants (Actual)Interventional2008-01-31Terminated(stopped due to Human metabolite not yet covered sufficiently by nonclinical data)
A 8-week, Multi-Centre, Open-label, Non-comparative, Phase IV Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR) With Daily Dose 400mg-800mg in the Treatment of Acute Schizophrenic Patients [NCT00779506]Phase 496 participants (Actual)Interventional2008-11-30Completed
A 3 Weeks Open Label Study to Evaluate the Efficacy in Agitation and Safety of Quetiapine Fumarate XR in Treatment of Patients With Acute Schizophrenia [NCT00954122]Phase 435 participants (Actual)Interventional2009-09-30Completed
A Pilot Study of Three-Week, Randomised, Open Comparison in Schizophrenic In-patients Treated With Quetiapine Prolong or Oral Risperidone at Flexible Dose [NCT00660595]Phase 329 participants (Actual)Interventional2008-09-30Terminated(stopped due to To difficult to recruit patients in the acute setting)
Assessment of the Inter-patient Variability in Clinical Response and Correlated Genetic Variations in Substance Use Disorders [NCT05833399]200 participants (Anticipated)Observational2022-11-28Recruiting
An Open Label, Multicenter, Single Arm, 4-Week Study to Evaluate the Efficacy and Safety of Flexible Dose of Quetiapine Fumarate (Seroquel) Switching From Other Drugs in the Treatment of Acute Manic Patients With Bipolar Disorder [NCT00837343]Phase 4120 participants (Anticipated)Interventional2008-12-31Recruiting
An 8-week, Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended-Release in Children and Adolescent Subjects With Bipolar Depression [NCT00811473]Phase 3193 participants (Actual)Interventional2009-01-31Completed
Brain Derived Neurotrophic Factor as a Predictor of Response to Treatment in Bipolar Depression and Mania: 16-weeks Follow-up With Quetiapine XR [NCT00879307]Phase 3100 participants (Anticipated)Interventional2009-03-31Recruiting
Effectiveness of 6 Antipsychotic Drugs in the Treatment of Acute Exacerbations of Chronic Inpatients With Schizophrenia: a Randomized Double-blind Study [NCT02192723]550 participants (Actual)Interventional2012-06-30Completed
Quetiapine Augmentation of Prolonged Exposure (PE) Therapy for the Treatment of Co-occurring PTSD and Mild Traumatic Brain Injury [NCT04280965]Early Phase 128 participants (Actual)Interventional2019-02-01Completed
Prospective, Double-Blind, Randomized Controlled Trial of Quetiapine as a Treatment for Delirium in Critically Ill Children [NCT03572257]Phase 2/Phase 30 participants (Actual)Interventional2019-04-15Withdrawn(stopped due to Closed due to inability to enroll)
Cannabidiol as a Different Type of an Antipsychotic: Drug Delivery and Interaction Study With Approved Antipsychotics in Vivo [NCT02051387]Phase 174 participants (Actual)Interventional2013-01-31Completed
Open-Label Pharmacokinetic Study to Evaluate the Steady-State Venous and Capillary Plasma Concentrations of Five Antipsychotics: Aripiprazole, Olanzapine, Paliperidone, Quetiapine and Risperidone [NCT02087579]Phase 1305 participants (Actual)Interventional2014-02-28Completed
A Double-Blind, Randomized, Multiple Dose Study of Weight Associated Parameters: SEP-363856 vs Prior Antipsychotic (PA) Standard of Care in Subjects With Schizophrenia Suffering From Metabolic Dysregulation [NCT05542264]Phase 160 participants (Anticipated)Interventional2022-11-15Recruiting
A Double-Blind, Placebo-Controlled Trial of Seroquel for the Treatment of Dysphoric Hypomania in Bipolar II Patients [NCT00186043]Phase 455 participants (Actual)Interventional2008-08-31Completed
Double-blind Placebo-controlled Trial of Quetiapine in Anorexia Nervosa [NCT00518973]21 participants (Actual)Interventional2006-07-31Completed
Interventions to Test the Alpha7 Nicotinic Receptor Model in Schizophrenia [NCT00509067]Phase 243 participants (Actual)Interventional2007-11-30Completed
Impact of Quetiapine Prolong and Escitalopram on the Hypothalamic-pituitary-adrenocortical (HPA)-Axis Activity in Depressed Patients [NCT00953108]Phase 360 participants (Actual)Interventional2009-09-30Completed
A Randomized Controlled Trial to Evaluate the Effectiveness of Clozapine Versus Olanzapine, Quetiapine or Risperidone in Treatment Resistant Bipolar Disorder [NCT02562287]Phase 454 participants (Anticipated)Interventional2015-10-31Recruiting
CARE II - Evaluation of Treatment Outcomes in Schizophrenic Patients Taking Part in the Integrated Care Program - a Single-country, Multi-centre Phase IV Study [NCT00681629]Phase 47 participants (Actual)Interventional2008-07-31Terminated(stopped due to Difficulty finding eligible sites/patients; current situation in health policy cause negative effect on existing/planned contracts for integrated care program)
Effect of Quetiapine XR on Sleep in Patients With Major Depression, as Compared With Mirtazapine [NCT00782405]Phase 340 participants (Anticipated)Interventional2008-10-31Completed
Quetiapine Related Neurochemical Changes as Measured by Magnetic Resonance Spectroscopy in Patients With Schizophrenia [NCT00797927]Phase 430 participants (Actual)Interventional2007-01-31Completed
A Multicentre, Open-label, Prospective Long-term Study Evaluating the Clinical Benefit and Effectiveness of SEROQUEL XR® (Quetiapine Fumarate Extended-Release Tablets) in Subjects With Schizophrenia [NCT00640601]Phase 3331 participants (Actual)Interventional2008-03-31Completed
A Multicenter, Open Label, Flexible-dose, Parallel-group Evaluation of the Cataractogenic Potential of Quetiapine Fumarate (Seroquel) and Risperidone (Risperdal) in the Long Term Treatment of Participants With Schizophrenia or Schizoaffective Disorder [NCT00206102]Phase 41,098 participants (Actual)Interventional2003-09-30Completed
Multimodal Neuroimaging of Treatment Effects in Adolescent Mania [NCT00893581]169 participants (Actual)Interventional2009-03-31Completed
A Phase IV, Multi-center, Double-blind, Double-dummy, Randomized, Parallel-group Study to Compare the Tolerability of Quetiapine Fumarate Immediate Release (Seroquel IR) With Quetiapine Fumarate Extended Release (Seroquel XR) During Initial Dose Escalatio [NCT00926393]Phase 4139 participants (Actual)Interventional2009-06-30Completed
Comparative Efficacy of Antidepressant Augmentation With Amantadine vs Pramipexole vs Quetiapine in Treatment-resistant Unipolar Depression: A Randomized Controlled Trial. [NCT04936126]Phase 4150 participants (Anticipated)Interventional2021-08-07Recruiting
A One-Year Randomized, Prospective, Parallel, Open Comparison of Subjective Well-being in Schizophrenic Out-patients Treated With Quetiapine XR (SEROQUEL XR™) or Oral Risperidone at Flexible Dose in a Naturalistic Setting [NCT00600756]Phase 3798 participants (Actual)Interventional2008-01-31Completed
Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia:One-Year Follow up. [NCT00654576]Phase 41,400 participants (Anticipated)Interventional2005-02-28Completed
Determining the Efficacy and Tolerance of Quetiapine Extended Release (XR) for the Management of Psychotic Aggression or Agitation in Adult Acute Psychiatry [NCT00986167]Phase 472 participants (Anticipated)Interventional2009-10-31Not yet recruiting
Enhanced Identification of Very Early Response to Seroquel XR Added to an Antidepressant for the Treatment of Major Depressive Disorder With or Without Generalized Anxiety Disorder [NCT00892463]Phase 426 participants (Actual)Interventional2009-05-31Completed
A Randomized Open-label Active-controlled Study to Evaluate the Efficacy and Safety of Utapine Versus Seroquel in Patients With Bipolar Mania [NCT01043679]Phase 440 participants (Anticipated)Interventional2009-07-31Recruiting
The Efficacy and Safety of Once-daily Quetiapine Extended Release in Patients With Schizophrenia Switched From Other Antipsychotics [NCT02142556]Phase 361 participants (Actual)Interventional2008-11-30Completed
A Multicenter, Rand., Double-blind, Parallel-group, Pbo-controlled Study of the Efficacy and Safety of SEROQUEL® XR Compared With Pbo as an Adjunct to Treatment in Patients With Generalized Anxiety Disorder Who Demonstrate Partial or No Response to a SSRI [NCT00534599]Phase 3409 participants (Actual)Interventional2007-08-31Completed
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Parallel-group Study to Assess the Safety and Efficacy of ASP4345 as Add-on Treatment for Cognitive Impairment in Subjects With Schizophrenia on Stable Doses of Antipsychotic Medication [NCT03557931]Phase 2233 participants (Actual)Interventional2018-07-13Completed
A Multicenter, Double-Blind, Randomized, Comparison of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) and Placebo in the Treatment of Agitation Associated With Dementia. [NCT00621647]Phase 3333 participants (Actual)Interventional2002-09-30Completed
Quetiapine in the Treatment of Psychotic Depression - a Pilot Study [NCT00751504]Phase 316 participants (Actual)Interventional2008-09-30Completed
A Randomised, Multi-Centre Study to Compare the Efficacy and Safety of Extended Release Quetiapine Fumarate (Seroquel XR TM) Tablets as Mono-Therapy or in Combination With Lithium in the Treatment of Patients With Acute Bipolar Depression [NCT00883493]Phase 3421 participants (Actual)Interventional2009-04-30Completed
[NCT00486798]Phase 30 participants Interventional2007-05-31Terminated(stopped due to study was not ethically acceptable to continue and therefore it was finally stopped)
A Randomised, 6-week, Multicentre, Open-label, Rater-blinded Parallel Group Study Comparing Quetiapine Extended Release Monotherapy and Augmentation With Lithium Augmentation in Patients With Treatment Resistant Depression [NCT00789854]Phase 3688 participants (Actual)Interventional2008-11-30Completed
A Phase 3 Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Study the Safety and Efficacy of Lurasidone in Subjects With Schizophrenia (PEARL 3 Extension Study) [NCT00789698]Phase 3240 participants (Actual)Interventional2008-12-31Completed
An Open Label, 4-Week, Randomised, Multi-Centre, Phase IV Study to Compare the Efficacy and Safety of Quetiapine Fumarate (Seroquel) as Mono-Therapy or Adjunct to Lithium in the Treatment of Patients With Acute Mania in Bipolar Disorder [NCT00672490]Phase 4376 participants (Actual)Interventional2008-04-30Completed
Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients [NCT02612948]Phase 482 participants (Actual)Interventional2013-11-30Completed
A Comparison of the Effectiveness of Seroquel XR and Seroquel XR Plus Lithium in Patients With Acute Bipolar Mania: An Open-label, Randomized, Parallel Groups, Rater-blinded, 4 Week, Multicenter, Comparative, Phase 4 Study [NCT01254721]Phase 4131 participants (Actual)Interventional2010-12-31Terminated(stopped due to Difficulty of recruitment.)
Effect of Quetiapine on Marijuana Withdrawal and Relapse [NCT00743366]Phase 220 participants (Actual)Interventional2008-08-31Completed
Atypical Antipsychotics and Hyperglycemic Emergencies: Multicentre, Retrospective Cohort Study of Administrative Data [NCT02582736]725,489 participants (Actual)Observational2012-04-30Completed
A 6-Week, Multicenter, Rater-blind, Randomized, Risperidone-controlled Study to Evaluate the Efficacy and Safety of Seroquel (Quetiapine Fumarate) in the Treatment of Chinese Han Patients With Schizophrenia [NCT00817648]Phase 4120 participants (Actual)Interventional2008-12-31Completed
Quetiapine XR in the Treatment of Comorbid Generalized Anxiety Disorder in Bipolar Depression With or Without Substance Use Disorder [NCT00671853]Phase 3120 participants (Actual)Interventional2008-04-30Completed
Randomized, Open-Label, Balanced, Two-treatment, Two-period, Two-sequence, Crossover, Multicentric Experimental Bioequivalence Study of Quetiapine Fumarate Film-coated Tablets 300 mg (Test)and Seroquel Film-coated Tablets 300 mg (Reference) Under Fasting [NCT01566487]Phase 154 participants (Actual)Interventional2010-06-30Completed
A 4-week, Multi-Centre, Open-label, Non-comparative, Phase IV Study of the Broad Clinical Benefit for Seroquel XR (Quetiapine Fumarate Extended Release) With Flexible Dose as an add-on Therapy in the Treatment of Acute Bipolar Mania Patients With Partial [NCT01128114]Phase 432 participants (Actual)Interventional2010-06-30Terminated(stopped due to Poor recruitment)
Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia: a Randomized Clinical Trial [NCT06062953]Phase 2/Phase 3255 participants (Anticipated)Interventional2023-09-18Recruiting
Anxiolytic Effects of Single-dose Quetiapine XR Administration on Clinical Symptoms and Amygdala Activation During Exposure in Patients With Simple Phobia [NCT00872716]Phase 260 participants (Actual)Interventional2009-04-30Completed
An Open-Label, Non-Comparative, Multi-Centre, Phase II Prospective Trial to Assess the Efficacy of Quetiapine Fumarate Augmentation of Selective Serotonin Reuptake Inhibitors (SSRIs) in SSRI-Resistant Major Depressive Disorder. [NCT00733668]Phase 20 participants Interventional2006-03-31Completed
A Multinational, Randomised, Double-blind, Fixed-dose, Bifeprunox Study Combining a 12-Week Placebo-controlled, Quetiapine-referenced Phase With a 12-month Quetiapine-controlled Phase in Patients With Schizophrenia [NCT00658645]Phase 3227 participants (Actual)Interventional2008-03-31Terminated(stopped due to Interim analysis showed inadequate efficacy of bifeprunox)
Cardiovascular Biomarkers During Quetiapine Treatment of Depression [NCT00951483]Phase 491 participants (Actual)Interventional2009-07-31Completed
Study of Evaluating Quetiapine in Improving Sleep Quality of Schizophrenia [NCT00642369]60 participants (Actual)Interventional2008-03-31Completed
An Open Label, Randomised, Valproate-Controlled Study to Evaluate the Efficiency and Safety of Quetiapine Fumarate in the Treatment of Acute Manic Patients With Bipolar Disorder. [NCT00742638]70 participants (Anticipated)Interventional2008-03-31Recruiting
Quetiapine Augmentation for Primary Anxiety Disorder or Mood Disorders With Comorbid Anxiety Symptoms [NCT00912535]Phase 439 participants (Actual)Interventional2009-05-31Completed
An Open Label, 1-sequence Cross-over, Positron Emission Tomography (PET) Study With [11C]Raclopride to Determine Central D2 Dopamine Receptor Occupancy of Quetiapine Fumarate Immediate Release (SEROQUEL®) With Quetiapine Fumarate Extended Release (SEROQUE [NCT00832221]Phase 110 participants (Anticipated)Interventional2009-01-31Completed
A Multinational, Randomised, Double-Blind, Fixed-Dose, Bifeprunox Study Combining a 12-Week Placebo-Controlled, Quetiapine-Referenced Phase With a 12-Month Quetiapine-Controlled Phase in Patients With Schizophrenia [NCT00704509]Phase 3346 participants (Actual)Interventional2008-06-30Terminated(stopped due to Interim analysis showed inadequate efficacy of bifeprunox)
Clinical Study to Investigate the Effect of the Combination of Psychotropic Drugs and an Opioid on Ventilation [NCT04310579]Phase 155 participants (Actual)Interventional2020-06-15Completed
Interventional, Randomised, Double-blind, Parallel-group, Active-control, Multiple-dose Study Investigating the Effect of Lu AF35700 on Cardiac Repolarization in Men and Women With Schizophrenia and Schizoaffective Disorder [NCT02901587]Phase 1119 participants (Actual)Interventional2016-09-30Completed
Quetiapine Augmentation Versus Clomipramine Augmentation of Selective Serotonin Reuptake Inhibitors for Obsessive-compulsive Disorder Patients That do Not Respond to a SSRI Trial: a Randomized Open-trial. [NCT00564564]Phase 421 participants (Actual)Interventional2006-01-31Completed
Examination of the Pharmacokinetic Properties of Three Generic Medications and Their Respective Brand Preparations in Healthy Male Volunteers [NCT01400165]Phase 130 participants (Anticipated)Interventional2011-07-31Recruiting
A Randomized, Pilot Clinical Trial to Assess the Comparative Efficacy and Tolerability of Quetiapine XR Versus Amitriptyline for the Treatment of Patients With Fibromyalgia [NCT00766350]Phase 490 participants (Actual)Interventional2008-11-30Completed
An 8-week, Randomized, Double-Blind, Placebo-Controlled Trial of Seroquel SR Co-administration for SSRI-Resistant, Comorbid Panic Disorder [NCT00619892]Phase 426 participants (Actual)Interventional2008-02-29Completed
[NCT00919607]Phase 131 participants (Actual)Interventional2009-06-30Completed
A Randomized, Double-Blind, Placebo Controlled Exploratory Study of Augmentation of Seroquel XR With Pramipexole Dihydrochloride for Bipolar Depression [NCT00893841]Phase 296 participants (Actual)Interventional2009-02-28Completed
Quetiapine (Seroquel XR) for the Treatment of Fibromyalgia: a Clinical and Mechanistic Pilot Study [NCT00983320]Phase 452 participants (Actual)Interventional2008-04-30Completed
Use, Effects and Side-effects of Second-generation Antipsychotics in a Naturalistic Setting. [NCT00932529]Phase 4226 participants (Actual)Interventional2003-02-28Completed
A Double-blind, Double-dummy, Randomized, Crossover Study to Compare the Tolerability of Quetiapine Fumarate Immediate Release (SEROQUEL®) With Quetiapine Fumarate Extended Release (SEROQUEL XR®) During Initial Dose Escalation in Healthy Volunteers [NCT00702676]Phase 163 participants (Actual)Interventional2008-07-31Completed
The Effect of the Atypical Antipsychotic Quetiapine in the Treatment of Postpartum Depressive Disorder With Psychotic Symptoms [NCT00681668]Phase 25 participants (Actual)Interventional2007-08-31Terminated(stopped due to Recruitment behind plan, no increase expected)
A Single-center, Randomized, Double-blind, Phase III Comparison of the Efficacy and Safety of Quetiapine Fumarate (Oral Extended Release Tablets) to Placebo in Social Phobia Patients and Changes in Their Vasodilatory Response to Methyl-Nicotinate [NCT00773162]Phase 321 participants (Actual)Interventional2008-10-31Completed
A 12-Month Randomized, Open-Label Study of Caregiver Psycho-education and Skills Training in Patients Recently Diagnosed With Schizophrenia, Schizoaffective Disorder, or Schizophreniform Disorder and Receiving Paliperidone Palmitate or Oral Antipsychotic [NCT02600741]296 participants (Actual)Observational2015-07-24Completed
Phase I Study of FK949E - Multiple Dose Study of Elderly Adult Patients With Major Depressive Disorder [NCT01903200]Phase 116 participants (Actual)Interventional2010-02-28Completed
[NCT00838032]Phase 470 participants (Anticipated)Interventional2008-08-31Recruiting
Compare Efficacy and Safety Between Quetiapine and Haloperidol in Treatment Delirium [NCT00954603]Phase 352 participants (Actual)Interventional2009-06-30Terminated(stopped due to few delirious patients were enrolled.)
Phase 4 Study of Efficacy and Safety of Tandospirone Combined With Atypical Antipsychotic Drugs to Improve Cognitive Function in Schizophrenia [NCT02040883]Phase 4100 participants (Anticipated)Interventional2014-02-28Not yet recruiting
The Effects of Quetiapine XR on Cognition, Mood and Anxiety Symptoms in SSRI-Resistant Unipolar Depression [NCT00517387]Phase 364 participants (Anticipated)Interventional2007-09-30Completed
Treatment of Major Depressive Disorder With Psychotic Features With Quetiapine Monotherapy; Quetiapine and Citalopram; or Haloperidol and Citalopram [NCT00174603]Phase 360 participants Interventional2005-08-31Terminated(stopped due to Unable to recruit subjects)
Bariatric Surgery and Pharmacokinetics Quetiapine: BAR-MEDS Quetiapine [NCT03449472]12 participants (Anticipated)Observational2018-01-02Recruiting
The Use of Quetiapine (Seroquel) in the Treatment of Social Phobia: Effects on Cue Reactivity in Response to Virtual Reality Public Speaking Environment [NCT00407199]Phase 420 participants (Actual)Interventional2006-12-31Completed
[NCT00182013]Phase 4106 participants (Actual)Interventional2001-06-30Completed
A One-Year Multi-Centre Randomized, Double Blind, Controlled Effectiveness Study of Quetiapine and Olanzapine, Comparing Their Relative Potential in Improving Neuro-Cognitive Deficits, Functional Outcomes and Quality of Life in Schizophrenia [NCT00182442]Phase 480 participants Interventional2003-10-31Completed
A 26-week, Multicenter, Open-label Phase 3b Study of the Safety and Tolerability of Quetiapine Fumarate (SEROQUEL™) Immediate-release Tablets in Daily Doses of 400 mg to 800 mg in Children and Adolescents With Bipolar I Disorder and Adolescents With Schiz [NCT00227305]Phase 3381 participants (Actual)Interventional2004-08-31Completed
The Effects of Quetiapine on Sleep During Alcohol Abstinence [NCT00434876]Phase 322 participants (Actual)Interventional2007-08-31Completed
A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR) in the Treatment of Elderly Patients With Generalised Anxiety Disorder [NCT00389064]Phase 3450 participants (Actual)Interventional2006-09-30Completed
Effects of Quetiapine XR in Schizophrenic Patients With Cannabis Abuse and/or Cannabis Induced Psychosis -Pilot Study- [NCT01071135]Phase 35 participants (Actual)Interventional2009-09-30Terminated(stopped due to Planned number of 30 subjects could not be recruited during recruitment phase.)
A 16-Week, Multicenter, Randomized, Open-label Study to Assess the Effects of Aripiprazole Versus Other Atypical Antipsychotics in the Treatment of Schizophrenic Patients With Metabolic Syndrome [NCT00508157]Phase 4125 participants (Actual)Interventional2007-11-30Terminated(stopped due to Slow Accrual)
A 6-week, Multicenter, Double-blind, Double-dummy, Randomized Comparison of the Efficacy & Safety of Sustained-Release Formulation Quetiapine Fumarate (SEROQUEL) & Placebo in the Treatment of Acutely Ill Patients With Schizophrenia [NCT00206115]Phase 3535 participants Interventional2004-11-30Completed
A Placebo-controlled Trial of Adjunctive Quetiapine for Refractory PTSD [NCT00292370]Phase 4124 participants (Actual)Interventional2006-01-31Completed
A Comparative Study of New Medications for Psychosis in Adolescents [NCT00222495]30 participants Interventional2002-08-31Completed
[NCT00060489]Phase 30 participants Interventional2002-09-30Completed
Comparative Efficacy and Acceptability of Lithium, Valproate, Oxcarbazepine, Quetiapine, Olanzapine, and Ziprasidone in Bipolar I Disorder, Manic or Mixed Phase [NCT01893229]Phase 4120 participants (Anticipated)Interventional2013-09-30Recruiting
Phase I Study of FK949E - A Study of Drug-drug Interactions Between FK949E and Fluvoxamine in Healthy Male Adults [NCT01908296]Phase 124 participants (Actual)Interventional2011-07-31Completed
Phase I Study of FK949E - Comparison of Pharmacokinetics Between FK949E 50 mg Tablets and FK949E 150 mg Tablets in Patients With Major Depressive Disorder [NCT01919008]Phase 116 participants (Actual)Interventional2012-03-26Completed
An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine Versus Non-Clozapine Antipsychotics in Individuals With Treatment-resistant Schizophrenia [NCT05741502]Phase 460 participants (Anticipated)Interventional2023-08-16Recruiting
Algorithm Guided Treatment Strategies for Bipolar Depression [NCT01938859]Phase 4360 participants (Anticipated)Interventional2012-06-30Active, not recruiting
A 1-year, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Phase 3 Study to Evaluate Prevention of Relapse in Patients in Stable Chronic Schizophrenia Receiving Either Sustained-release Quetiapine Fumarate (SEROQUEL) or Placebo (A [NCT00228462]Phase 3197 participants (Actual)Interventional2005-03-31Completed
Multi-centre, Double-blind, Randomised, Parallel-group, Placebo-controlled, Phase 3 Study of the Efficacy & Safety of Quetiapine Fumarate & Lithium as Monotherapy in Adult Patients With Bipolar Depression for 8 Weeks & Quetiapine in Continuation (Abbrevia [NCT00206141]Phase 3672 participants Interventional2005-08-31Completed
A Randomized, Placebo-Controlled Trial of Quetiapine (Seroquel) Monotherapy in the Treatment of PTSD [NCT00237393]Phase 480 participants (Actual)Interventional2003-08-31Completed
A Single-Blind Prospective Study of Quetiapine for the Treatment of Mood Disorders in Adolescents [NCT00221468]Phase 320 participants (Actual)Interventional2003-06-30Completed
A Randomized, Open-Label, Single Dose, Cross-over Study of Gastric Emptying Rate: SEP-363856 vs Prior Antipsychotic Standard of Care in Subjects With Schizophrenia [NCT05402111]Phase 131 participants (Actual)Interventional2022-06-13Completed
Comparison of Venlafaxine Augmentation With Quetiapine v.s. Placebo in Treatment Resistant Depression [NCT00253266]Phase 4126 participants (Actual)Interventional2008-04-30Completed
Safety and Efficacy of Seroquel in First Episode Schizophrenia [NCT00254241]Phase 480 participants Interventional2002-05-31Completed
The Effect of Quetiapine on Psychotic-Like Symptoms in Borderline Personality Disordered Patients: A Randomised Placebo-Controlled Trial [NCT00254748]Phase 240 participants (Anticipated)Interventional2004-06-30Completed
An Open Label, Double-blind Discontinuation Study of Quetiapine (Extended Release) XR in Social Anxiety Disorder [NCT00606541]Early Phase 155 participants (Actual)Interventional2008-01-31Terminated(stopped due to The study was terminated by the sponsor due to budgetary issues)
Role of Quetiapine in the Prevention of ICU Delirium in Elderly Patients at a High Risk [NCT05793632]Phase 290 participants (Actual)Interventional2023-03-01Completed
A Phase II, 6-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group Trial With a Quetiapine Arm to Evaluate the Efficacy, Tolerability and Safety of Oral BI 1358894 in Patients With Major Depressive Disorder With In [NCT04521478]Phase 2389 participants (Actual)Interventional2020-11-20Active, not recruiting
Quetiapine vs. Placebo in Alcohol Relapse Prevention - a Pilot Study [NCT00561587]Phase 240 participants (Anticipated)Interventional2007-11-30Completed
Methamphetamine-Quetiapine Interaction in Humans: A Pilot Study [NCT00567866]Early Phase 110 participants (Actual)Interventional2008-01-31Terminated(stopped due to Study was terminated due to insufficient funds)
A Double Blind, Placebo Controlled Trial of Quetiapine in Anorexia Nervosa, a Dual Site Study [NCT00584688]Phase 224 participants (Actual)Interventional2007-02-28Terminated(stopped due to Lack of Enrollment)
Acute Psychotherapy for Bipolar II Depression [NCT01133821]Phase 492 participants (Actual)Interventional2010-08-31Completed
A Random Assignment,Parallel Group, Open Label Comparison of Clinical Outcomes and Resource Utilization Among Bipolar Disorder Patients Receiving Either Long Acting Injectable Risperidone Microspheres (Risperdal Consta® ) or Other Second Generation Oral A [NCT00177164]Phase 350 participants (Actual)Interventional2003-11-30Completed
A Randomized, Double-Blind, Placebo Controlled Study Of Quetiapine SR (QTP) As Adjunctive Treatment In Mixed States (MS) Of Bipolar Disorder [NCT01195363]Phase 428 participants (Actual)Interventional2007-04-30Completed
A Randomized, Open Label, Two-Treatment, Two-Period, Two-Sequence, Crossover, Single Dose, Bioequivalence Study of Quetiapine Fumarate Tablets 25 mg With Seroquel® 25 mg in Normal, Healthy, Adult, Human Subjects, Under Fasting Condition [NCT01603173]Phase 154 participants (Actual)Interventional2011-04-30Completed
Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies [NCT02893371]1,037,352 participants (Actual)Observational2016-09-30Completed
Comparison of Single-Dose Plasma and Blood Concentrations of Aripiprazole, Olanzapine, Quetiapine, Paliperidone and Risperidone After Capillary and Venous Blood Sample Collection [NCT01607762]Phase 131 participants (Actual)Interventional2012-02-29Completed
Comparison of Quetiapine Extended-Release (Seroquel XR™) and Risperidone in the Treatment of Depressive Symptoms, in Schizophrenic or Schizoaffective Patients: A Randomized, Open Label, Flexible-dose, Parallel Group, Non Inferiority, 12-week Study [NCT00640562]Phase 3216 participants (Actual)Interventional2008-02-29Completed
Seroquel XR for the Treatment of Peri and Postmenopausal Women With Major Depressive Disorder: Impact on Mood, Physical Symptoms, Sleep and Quality of Life [NCT00723970]Phase 440 participants (Actual)Interventional2007-06-30Completed
Randomized, Placebo-Controlled Effectiveness Study of Quetiapine XR in Co-Morbid Depressive and Anxiety Disorders [NCT00688818]108 participants (Actual)Interventional2008-06-30Completed
A Phase IV STudy of the Effectiveness of Quetiapine Extended Release 600mg Once a Day to Control the Symptoms of Manic Phase of Bipolar Disorder. [NCT00521365]Phase 488 participants (Actual)Interventional2008-05-31Completed
A 6-Week, Multi-centre, Double-blind, Double-dummy, Chlorpromazine-Controlled Randomised Study to Evaluate the Efficacy and Safety of Quetiapine Fumarate Extended-Release in the Treatment of Schizophrenic Patients With Acute Episode [NCT00882518]Phase 3388 participants (Actual)Interventional2009-04-30Completed
Effects of Seroquel on Sleep Architecture in Patients With Bipolar Depression or Major Depressive Disorder - An Open Label Study [NCT00616889]15 participants (Actual)Observational2006-05-31Completed
A Double Blind, Randomized Placebo Controlled Study of the Efficacy, Safety and Tolerability of Quetiapine Fumarate Sustained Release(Seroquel SRTM) in the Treatment of Major Depression With Comorbid Fibromyalgia Syndrome. [NCT00675896]Phase 4120 participants (Anticipated)Interventional2007-04-30Completed
The Interest of a Specific Combined Treatment (Psychotherapy and Pharmacotherapy) in Patients With Dissociative Disorders [NCT00630981]30 participants (Actual)Observational2008-02-29Active, not recruiting
A Fifteen-month, Prospective, Randomized, Active-controlled, Open-label, Flexible Dose Study of Paliperidone Palmitate Compared With Oral Antipsychotic Treatment in Delaying Time to Treatment Failure in Adults With Schizophrenia Who Have Been Incarcerated [NCT01157351]Phase 4450 participants (Actual)Interventional2010-05-31Completed
A Study of Individualized Diagnosis and Treatment for Major Depressive Disorder With Atypical Features [NCT04209166]780 participants (Anticipated)Interventional2019-08-12Recruiting
The Role of miR-30 Family Dysregulation in Response to Antipsychotic Treatment [NCT02650102]Phase 1/Phase 2200 participants (Anticipated)Interventional2013-01-31Recruiting
The Efficacy and Tolerability of Seroquel XR Combined With a Selective Serotonin Re-Uptake Inhibitor Versus Seroquel XR Monotherapy in the Acute Treatment of Major Depressive Disorder With Psychotic Features [NCT00955474]Phase 432 participants (Actual)Interventional2008-09-30Terminated(stopped due to AstraZeneca halted funding; patent expired for Seroquel (Quetiapine) in 2012)
Quetiapine Induced Neuroplasticity in Schizophrenic Patients: A Combined Transcranial Magnetic Stimulation (TMS) and Voxel-based Morphometry (VBM) Study [NCT00554658]Phase 430 participants (Actual)Interventional2008-03-31Completed
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate (SEROQUEL®) Compared With Placebo in the Treatment of Generalized Anxiety Disorder [NCT00329264]Phase 3876 participants (Anticipated)Interventional2006-04-30Completed
A 6-Week, Multicenter, Double-Blind, Double-Dummy, Randomized Comparison of the Efficacy and Safety of Sustained-Release Formulation Quetiapine Fumarate (SEROQUEL) and Placebo in the Treatment of Acutely Ill Patients With Schizophrenia [NCT00085891]Phase 3535 participants Interventional2004-06-30Completed
A 16-Week, Randomized, Controlled Trial of the Effect of Aripiprazole Versus Standard of Care on Non-HDL Cholesterol Among Patients With Schizophrenia and Bipolar I Disorder Who Have Pre-existing Metabolic Syndrome [NCT00857818]Phase 364 participants (Actual)Interventional2009-04-30Terminated(stopped due to Slow Accrual)
Effectiveness of Quetiapine XR Versus Sertraline in Acute Depression as add-on Therapy to Previous Mood Stabilizer Treatment: a Pilot Study [NCT00857584]Phase 327 participants (Actual)Interventional2009-05-31Completed
Seroquel on Glucose Metabolism [NCT00214578]Phase 4572 participants Interventional2004-04-30Completed
Clinical Trial to Investigate the Effect on Corrected QT Interval Prolongation by Psychotropic Drugs in Healthy Korean Adults After a Single Oral Administration of Escitalopram, Quetiapine, and Moxifloxacin [NCT01871701]Phase 140 participants (Actual)Interventional2012-11-30Completed
Phase I Study of FK949E - Multiple Dose Study of Non-Elderly Adult Patients With Major Depressive Disorder (MDD) [NCT01871974]Phase 116 participants (Actual)Interventional2009-05-31Completed
Pharmacokinetic Study of FK949E -A Pharmacokinetic Study in Healthy Male Volunteers to Investigate the Effect of Food on the Pharmacokinetics of FK949E [NCT01871987]Phase 124 participants (Actual)Interventional2009-06-30Completed
Phase 1 Study of Insulin Sensitivity, Adjusted β-Cell Function and Adiponectin Among Lean Drug-naïve Schizophrenic Subjects Treated With Atypical Antipsychotic Drugs [NCT00528359]36 participants (Actual)Observational2005-10-31Completed
Melancholic Depression and Insomnia as Predictors of Response to Quetiapine in Patients With Major Depression [NCT03207438]Phase 41,790 participants (Actual)Interventional2006-04-30Completed
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarate (Seroquel SR®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Depression [NCT00422214]Phase 3400 participants Interventional2006-12-31Completed
A Double Dummy & Double Blind, Multicenter, Randomized Study of the Efficacy and Safety of Seroquel (Quetiapine Fumarate) and Lithium as Monotherapy in the Treatment of Acute Mania in Patients With Bipolar Disorder [NCT00448578]Phase 3150 participants Interventional2005-08-31Completed
RAPID-An Open-Label Randomized, Multicenter Phase IIIb Study to Evaluate the Efficacy and Tolerability of Quetiapine IR (Immediate Release), Over 14 Days, in Acute Schizophrenia/Schizoaffective Disorder (Rapid Versus Conventional Titration) [NCT00457899]Phase 3234 participants (Anticipated)Interventional2007-07-31Terminated(stopped due to Study terminated due to poor recruitment)
12 Week Prospective Double Blind Placebo Controlled Randomized Trial of Seroquel SR for Alcohol Dependence and Comorbid Anxiety [NCT00352469]Phase 420 participants (Anticipated)Interventional2006-02-28Completed
[NCT00462618]Phase 2/Phase 332 participants (Actual)Interventional2007-04-30Completed
Antipsychotic Polypharmacy in Schizophrenia [NCT00493233]100 participants (Anticipated)Interventional2006-11-30Completed
Double-Blind, Randomized, Parallel-Group Study With Quetiapine Extended Release as Comparator to Evaluate the Efficacy and Safety of Seltorexant 20 mg as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients With Major Depressive Disorder Wi [NCT04513912]Phase 3757 participants (Actual)Interventional2020-09-15Completed
Single-arm, Open-label and Multicenter Phase IV Study: Efficacy and Safety of Quetiapine in Treating Affective Symptoms of Patients With First-episode Psychosis - a Pilot Study [NCT00511277]Phase 460 participants (Anticipated)Interventional2007-08-31Completed
Schizophrenia Sensory Gating Deficit With Quetiapine [NCT00536783]20 participants (Anticipated)Observational2004-04-30Completed
Open-Label Pilot Study of Quetiapine Treatment for Cannabis Dependence [NCT00954681]Phase 215 participants (Actual)Interventional2009-08-31Completed
Quetiapine and the Dopaminergic Epigenetic Control - a Pilot Study [NCT00370500]Phase 4100 participants (Actual)Interventional2007-04-30Completed
A Double Blind, Randomized Placebo Controlled Study of the Efficacy, Safety and Tolerability of Immediate-Release Formulation of Quetiapine Fumarate as Potentiation of Selective Serotonin Reuptake Inhibitors, and Serotonin Norepinephrine Reuptake Inhibito [NCT00229645]Phase 460 participants Interventional2003-11-30Completed
Differences in Cognitive Function Due to Acute Sedative Effects of Risperidone and Quetiapine in Stable Bipolar I Out-Patients. [NCT00097032]Phase 330 participants (Actual)Interventional2004-10-31Completed
Efficacy of Quetiapine in the Reduction of Cocaine Use and Cravings in Individuals With Cocaine Dependence [NCT00232336]Phase 442 participants (Actual)Interventional2003-10-31Completed
A Double-Blind Randomized Placebo Controlled Study of Quetiapine for the Treatment of Depression in Adolescents With Bipolar Disorder [NCT00232414]Phase 330 participants (Anticipated)Interventional2005-10-31Completed
Quetiapine for the Treatment of Insomnia Associated With Alzheimer's Disease [NCT00232570]18 participants (Anticipated)Interventional2005-11-30Recruiting
A Multicenter, Randomized, Naturalistic, Open-Label Study Between Aripiprazole and Standard of Care in the Management of Community-Treated Schizophrenic Patients (Schizophrenia Trial of Aripiprazole - STAR) [NCT00237913]Phase 3700 participants Interventional2004-07-31Completed
Quetiapine (Seroquel) Maintenance Treatment in Early Onset Bipolar Spectrum Disorders: An Open Prospective Longitudinal Study of the Effectiveness of Quetiapine Monotherapy in Preventing Relapse and Minimizing Neurocognitive Dysfunction Among Adolescents [NCT00252226]Phase 3100 participants (Anticipated)Interventional2004-06-30Completed
A Multi-Centre, Double-Blind, Randomised-Withdrawal, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (SEROQUEL SR™) As Monotherapy in the Maintenance Treatment of Patients With Major D [NCT00278941]Phase 33,000 participants Interventional2005-12-31Completed
Dopaminergic Modulation of Choroidal Blood Flow Changes During Dark/Light Transitions [NCT00280501]21 participants (Actual)Interventional2005-08-31Completed
Multicentre, Double-blind, Randomised, Parallel Group, Placebo Controlled, Phase 3 Study of the Efficacy & Safety of Quetiapine Fumarate & Paroxetine as Monotherapy in Adult Patients With Bipolar Depression for 8 Weeks & Quetiapine in Continuation (Abbrev [NCT00119652]Phase 3676 participants (Actual)Interventional2005-05-31Completed
Multicenter, Randomized, Parallel-Group, Double-Blind, Phase 3 Comparison of the Efficacy & Safety of Quetiapine Fumarate to Placebo as Adjunct to Mood Stabilizers (Lithium or Divalproex) in the Maintenance Treatment of Bipolar I Disorder in Adult Patient [NCT00081380]Phase 3710 participants Interventional2004-03-31Completed
Efficacy of Quetiapine in Generalised Social Anxiety Disorder, a Double-blind, Placebo-controlled Study [NCT00302770]Phase 350 participants (Anticipated)Interventional2006-06-30Terminated(stopped due to This study was terminated due to poor enrollment)
Interaction Between IV Cocaine and Quetiapine [NCT00087750]Phase 112 participants Interventional2003-10-31Active, not recruiting
Efficacy of Quetiapine Compared to Risperidone on Negative Symptoms and Cognition With Regard to Underlying Neurobiological Mechanisms and Brain Activation. [NCT00305422]Phase 345 participants (Actual)Interventional2001-11-30Completed
The Comparison of Efficacy and Safety of Continuing Olanzapine to Switching to Quetiapine in Overweight or Obese Patients With Schizophrenia and Schizoaffective Disorder [NCT00090012]Phase 4340 participants Interventional2004-07-31Completed
Quetiapine Treatment for Symptoms Associated With Borderline Personality Disorder [NCT00122070]Phase 315 participants (Actual)Interventional2005-05-31Completed
A 6-week, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase 3b Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL™) Immediate-release Tablets Compared With Placebo in Adolescents With Schizophrenia (Abbreviate [NCT00090324]Phase 3249 participants (Anticipated)Interventional2004-09-30Completed
Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial [NCT00328822]16 participants (Anticipated)Interventional2006-12-31Completed
A Canadian, Multicenter, Double-Blind, Randomized, Parallel-Group Study of the Safety, Tolerability, and Efficacy of Treatment With Higher Doses of Quetiapine Fumarate (Seroquel®) Greater Than 800 mg/Day in Schizophrenic or Schizoaffective Subjects. [NCT00328978]Phase 3330 participants Interventional2003-10-31Completed
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate (SEROQUEL®) Compared With Placebo in the Treatment of Generalized Anxiety Disorder [NCT00329446]Phase 3800 participants (Anticipated)Interventional2006-04-30Completed
A Confirmatory Multicenter, Double-blind, Randomized, Placebo Controlled Study of the Use of Quetiapine Fumarate (SEROQUEL) in the Treatment of Patients With Bipolar Depression [NCT00083954]Phase 3530 participants Interventional2004-06-30Completed
A Double-Blind Study of Quetiapine Fumarate (Seroquel) for the Treatment of Type A vs.Type B Alcoholics. [NCT00124059]Phase 361 participants (Actual)Interventional2003-03-31Completed
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled and Active-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained-Release (SEROQUEL®) as Monotherapy in the Treatment of Patients With MDD [NCT00321490]Phase 3600 participants Interventional2006-04-30Completed
A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Paliperidone ER Compared to Quetiapine in Subjects With an Acute Exacerbation of Schizophrenia [NCT00334126]Phase 3399 participants (Actual)Interventional2006-04-30Completed
A 3-wk, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Phase 3b Study of the Efficacy & Safety of Quetiapine Fumarate (SEROQUEL™) Immediate-release Tablets in the Treatment of Children & Adolescents With Bipolar I Mania (Abbrev [NCT00090311]Phase 3220 participants (Actual)Interventional2004-07-31Completed
A Multicenter, Open-Label, Parallel-Group, Randomized, Flexible Dose Study To Evaluate the Safety and Tolerability of Switching From Existing Atypical Antipsychotics to Bifeprunox in Subjects With Schizophrenia or Schizoaffective Disorder [NCT00347425]Phase 3286 participants (Actual)Interventional2006-12-31Completed
A 24-Week, Multi-Centre, Open-Label, Single-Arm, Phase IV Study of the Efficacy and Safety of Seroquel (Quetiapine Fumarate) With Daily Dose 600mg-750mg as Mono-Therapy in the Treatment of Acute Schizophrenic Patients [NCT00428350]Phase 4120 participants (Anticipated)Interventional2006-12-31Completed
Phase IV Study to Investigate if Valproate Add-on Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients [NCT00139074]Phase 417 participants (Actual)Interventional2005-07-31Terminated(stopped due to terminated due to very low recruitment rate (27 June 2006))
A Multi-Centre, Double-Blind, Randomised, Parallel Group, Placebo- Controlled and Active Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) as Mono- Therapy in the Treatment of Adult Patients Wit [NCT00351169]Phase 3450 participants (Anticipated)Interventional2006-05-31Completed
A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) in Combination With an Antidepressant in the Treatment of Patients With Major [NCT00351910]Phase 3494 participants (Actual)Interventional2006-05-31Completed
A Multicenter, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind, Phase III Study to Compare the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) Versus Placebo as Adjunct Therapy With Mood Stabilizers (Lithium or Divalproex) for the Trea [NCT00114686]Phase 3350 participants Interventional2006-01-31Completed
Randomized, Open Label, 8-Week Study of Quetiapine and Risperidone on Quality of Life in Female With Schizophrenia [NCT00498004]Phase 4100 participants (Anticipated)Interventional2007-08-31Terminated(stopped due to difficult to recruit subject)
Pharmacological Augmentation Strategies for Obsessive Compulsive Disorder Patients Non-respondent to First Line Medication Treatment: a Double Blind Placebo Controlled Study [NCT00466609]Phase 454 participants (Actual)Interventional2007-05-31Completed
Quetiapine XR Monotherapy or Adjunctive Therapy to Antidepressants in the Treatment of Major Depressive Disorder With Comorbid Generalized Anxiety Disorder [NCT00868374]Phase 323 participants (Actual)Interventional2008-06-30Terminated(stopped due to Study terminated due to low enrollment)
Comparative Effectiveness of a Second Generation Antipsychotic Mood Stabilizer And a Classic Mood Stabilizer for Bipolar Disorder [NCT01331304]Phase 4482 participants (Actual)Interventional2010-09-30Completed
Tolerability, Safety, And Efficacy Of Ziprasidone (80 - 160 Mg/D) Versus Olanzapine (10 - 20 Mg/D), Risperidone (4 - 8 Mg/D) Or Quetiapine (300 - 750 Mg/D) In Pretreated Patients With Schizophrenia, Schizoaffective Disorder Or Schizophreniform Disorders - [NCT00159770]Phase 3290 participants Interventional2001-11-30Completed
[NCT00161018]Phase 3150 participants Interventional2003-11-30Completed
Seroquel (Quetiapine) Therapy for Schizophrenia and Schizoaffective Disorders and Comorbid Cocaine and/or Amphetamine Abuse/Dependence: A Comparative Study With Risperidone [NCT00208143]Phase 420 participants Interventional2003-11-30Completed
Effectiveness of Atypical Vs Conventional Antipsychotics [NCT00237861]Phase 40 participants InterventionalCompleted
Rapid Dose Escalation of Quetiapine Versus Conventional Escalation in the Treatment of Patients With Acute Schizophrenia - a Multicentre, Double-Blind, Parallel Group, Randomized Study [NCT00254787]Phase 230 participants Interventional2005-06-30Completed
An International, Multicenter, Double-blind, Randomized, Placebo-controlled, Phase IV Study of the Safety and Efficacy of Lithium Versus Placebo as an Add on to SEROQUEL XR (Quetiapine Fumarate) in Adult Patients With Acute Mania [NCT00931723]Phase 4356 participants (Actual)Interventional2009-06-30Completed
Functional and Neurochemical Brain Changes in First-episode Bipolar Mania Following Successful Treatment With Lithium or Quetiapine [NCT00609193]81 participants (Actual)Observational2008-01-31Completed
A Phase IV Prospective, Double-blind, Double-dummy, Randomised, Crossover Study to Assess the Impact on Daily Cognitive Functioning of Quetiapine Fumarate Immediate Release (Seroquel IR®) Dosed Twice Daily and Quetiapine Fumarate Extended Release (Seroque [NCT01213836]Phase 475 participants (Actual)Interventional2010-11-30Completed
A Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL) Extended Release as Monotherapy in the Treatment of Patients With Bipolar Depression [NCT01256177]Phase 3361 participants (Actual)Interventional2010-12-31Completed
A Naturalistic, Prospective, Single Centre, Double Blinded, Fixed Dose, Randomised, Four Week Comparison Study Investigating Efficacy, Tolerability and Safety of 200 mg Per Day Versus 400 mg Per Day Quetiapine Fumarate in 200 Drug naïve First Episode Psyc [NCT00449397]Phase 3150 participants Interventional2003-07-31Completed
A Randomised, Controlled Trial to Investigate the Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment. [NCT05973786]Phase 4418 participants (Anticipated)Interventional2023-11-01Not yet recruiting
An Open Label Dose Titration Study of Quetiapine XR in the Treatment of Postpartum Depression in Nonlactating Women Diagnosed With Bipolar Disorder (BD), Type II. [NCT01527448]26 participants (Actual)Interventional2008-04-30Completed
Effects of Quetiapine on Ultrastructural Hippocampal and Neurochemical Changes in Patients With Bipolar Disorder: Searching for Antidepressant and Mood Stabilising Neurophysiology [NCT01552837]33 participants (Actual)Interventional2007-12-31Completed
A Multicenter, Randomized, Parallel-Group, Double-Blind, Phase 3 Comparison of the Efficacy & Safety of Quetiapine Fumarate to Placebo When Used as Adjunct to Mood Stabilizers (Lithium or Valproate) in the Maintenance Treatment of Bipolar I Disorder in Ad [NCT00107731]Phase 3710 participants Interventional2004-04-30Completed
A Randomized, Multicenter, Double-Blind, Parallel Group Study To Compare the Effects of Bifeprunox and Quetiapine on Weight Changes in Stable Schizophrenic Patients [NCT00396214]Phase 383 participants (Actual)Interventional2007-04-30Terminated(stopped due to This trial discontinued on 2 May 2008 due to lack of enrolment)
Comparative Effectiveness of Antipsychotic Medications in Patients With Schizophrenia (CATIE Schizophrenia Trial) [NCT00014001]Phase 41,600 participants Interventional2000-12-31Completed
Treatment of Agitation/Psychosis in Dementia/Parkinsonism (TAP/DAP) [NCT00043849]Phase 460 participants Interventional2002-07-31Completed
Treatment and Outcome of Early Onset Bipolar Disorder [NCT00048802]Phase 440 participants Interventional2002-08-31Completed
Comparative Effectiveness of Antipsychotic Medications in Patients With Alzheimer's Disease (CATIE Alzheimer's Disease Trial) [NCT00015548]450 participants Interventional2001-03-31Completed
Predicting the Optimal Pharmacotherapy for Outpatients With Schizophrenia [NCT00018642]0 participants Interventional1997-04-30Completed
[NCT00034905]Phase 40 participants Interventional2001-07-31Completed
Psychopharmacologic Aspects of Motor Slowing in Schizophrenia [NCT00018668]Phase 40 participants Interventional2000-10-31Completed
6-week Multicenter, Double-blind, Randomized, Parallel-group, Phase 3 Study to Evaluate the Feasibility of Switching From Immediate-release Quetiapine Fumarate (SEROQUEL) to Sustained-release Quetiapine Fumarate in Outpatients With Schizophrenia (Abbrevia [NCT00206128]Phase 3454 participants (Actual)Interventional2004-11-30Completed
5-HT2A-receptor Binding: Implications for the Pathophysiology of Schizophrenia and Effects of Treatment With Antipsychotic Drugs [NCT00207064]46 participants (Actual)Interventional2004-04-30Completed
Randomized Comparison of Monotherapy (Risperidone, Quetiapine, or Olanzapine) Versus Combination Therapy (Risperidone, Quetiapine, or Olanzapine + Divalproex)in the Management of Dementia With Agitation: A Pilot Comparison of Two Standard Therapies [NCT00208819]Phase 450 participants (Anticipated)Interventional2003-09-30Completed
A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Quetiapine in Social Anxiety Disorder [NCT00215254]Phase 2/Phase 315 participants Interventional2004-03-31Completed
A Randomized, Double-Blind, Placebo-Controlled Add-On Trial of Quetiapine in Patients With Bipolar Disorder and Cocaine Dependence [NCT00223210]Phase 4100 participants (Actual)Interventional2005-11-30Completed
A Randomized, Double Blind Study to Evaluate the Efficacy and Safety of Two Atypical Antipsychotics vs. Placebo in Patients With an Acute Exacerbation of Either Schizophrenia or Schizoaffective Disorder [NCT00061802]Phase 4225 participants (Actual)Interventional2003-06-30Completed
A Randomized, Double-Blind, Placebo-Controlled Add-On Trial of Quetiapine in Patients With Bipolar Disorder and Alcohol Abuse/ Dependence. [NCT00223249]Phase 4115 participants (Actual)Interventional2002-11-30Completed
Preventing Relapse: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy (PROACTIVE) [NCT00330863]Phase 4357 participants (Actual)Interventional2006-05-31Completed
Psychotherapy for Bipolar II Depression, Pilot Study, Phase II [NCT00411463]Phase 2/Phase 325 participants (Actual)Interventional2006-12-31Completed
CONSTATRE: Risperdal Consta Trial Of Relapse Prevention And Effectiveness [NCT00216476]Phase 3753 participants (Actual)Interventional2004-10-31Completed
Glucose and Lipid Metabolism on Antipsychotic Medication [NCT00515723]96 participants (Actual)Interventional2001-09-30Completed
A Phase II Double-blind, Placebo-controlled Trial of Quetiapine for Frequent, Heavy Drinkers (Seroquel2) [NCT00674765]Phase 2156 participants (Actual)Interventional2008-01-31Completed
Open-label Multicentre Study on Efficacy and Safety of Oral Quetiapine (Seroquel XR) in Adults With Schizophrenia [NCT00852631]Phase 328 participants (Actual)Interventional2009-02-28Terminated(stopped due to The study was prematurely terminated due to insufficient recruitment.)
Seroquel XR for the Management of Borderline Personality Disorder (BPD) [NCT00880919]Phase 395 participants (Actual)Interventional2008-06-30Completed
Neuroleptic Induced Movement Disorders in Older Patients [NCT00255879]Phase 1250 participants Interventional1999-01-31Completed
A Randomized Control Trial Comparing Quetiapine to Risperidone in Bipolar Disorder Outpatients With Current Stimulant Dependence [NCT00227123]96 participants (Actual)Interventional2002-10-31Completed
Quetiapine Decreases Smoking in Patients With Chronic Schizophrenia [NCT00231101]40 participants Interventional2004-01-31Recruiting
A 12-week International, Multicenter, Open Label, Non-comparative Study to Evaluate the Feasibility of Switching Any Antipsychotic Treatment to Sustained-release Quetiapine Fumarate (SEROQUEL®) in Patients With Schizophrenia [NCT00234377]Phase 3550 participants Interventional2004-11-30Completed
Quetiapine Augmentation in Severe Obsessive Compulsive Disorder (OCD) - Pilot Study [NCT00254735]Phase 344 participants (Actual)Interventional2002-04-30Completed
Pilot Study of the Efficacy and Safety of Quetiapine Compared With Valproate in the Treatment of Patients With Bipolar Disorder and Rapid Cycling: an Open Trial [NCT00254774]Phase 344 participants (Actual)Interventional2002-01-31Completed
Fast Titration Of Quetiapine Versus Currently Approved Titration: A Randomised, Multicentre, Parallel Group Open Trial In Schizophrenia And Schizoaffective Disorder [NCT00254813]Phase 3150 participants Interventional2004-10-31Completed
An Open, Randomised, Parallel, Three Treatment Groups, Multicentre, Phase IV Study - in Real Life - to Compare the Change in Social Outcome of Quetiapine Fumarate (Seroquel®) Combined With Cognitive Remediation Therapy to Conventional Treatment in Patient [NCT00255515]Phase 485 participants (Actual)Interventional2005-09-30Completed
A Randomized, Open Label, Two-Treatment, Two-Period, Two-Sequence, Crossover, Single Dose, Bioequivalence Study of Quetiapine Fumarate Tablets 25 mg With Seroquel® 25 mg in Normal, Healthy, Adult, Human Subjects, Under Fed Condition [NCT01603186]Phase 154 participants (Actual)Interventional2011-04-30Completed
A Multicentre, Parallel Group, Randomised, Double Blind, Placebo Controlled Study of the Use of Quetiapine as an Add on Therapy in the Treatment of Post Traumatic Stress Disorder [NCT00306540]Phase 390 participants (Anticipated)Interventional2004-12-31Completed
Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Quetiapine Fumarate and Lithium as Monotherapy for up to 104 Weeks Maintenance Treatment of Bipolar I Disorder in Adult Patients [NCT00314184]Phase 31,255 participants (Actual)Interventional2005-03-31Completed
A Randomized, Double-Blind, Placebo-Controlled Study of Quetiapine Monotherapy in Ambulatory Bipolar Spectrum Disorder With Moderate-to-Severe Hypomanic Symptoms or Mild Manic Symptoms [NCT00277667]Phase 340 participants (Anticipated)Interventional2004-02-29Completed
Depakote ER vs. Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia [NCT00315900]Phase 320 participants (Actual)Interventional2006-05-01Terminated(stopped due to Investigator closed study and left VAMC.)
Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed Extended-Release Paliperidone Compared With Flexibly-Dosed Quetiapine and Placebo in the Treatment of Acute M [NCT00309699]Phase 3493 participants (Actual)Interventional2006-04-30Completed
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained-Release (SEROQUEL®) as Monotherapy in the Treatment of Patients With MDD [NCT00320268]Phase 3600 participants Interventional2006-04-30Completed
Fast Titration of Quetiapine Versus Conventional Titration in the Treatment of Schizophrenia/Schizoaffective Disorder: a Randomised, Parallel Group Open Trial [NCT00304473]Phase 340 participants Interventional2004-08-31Completed
A Multicenter, Randomized, Double-blind, Placebo-controlled, 16 Week Study of Aripiprazole Used as Dual Therapy in the Treatment of Patients With Chronic Stable Schizophrenia or Schizoaffective Disorder Demonstrating an Inadequate Response to Quetiapine o [NCT00325689]Phase 4323 participants (Actual)Interventional2006-07-31Completed
The Impact of Quetiapine on the Drug Abuse Patterns of Addicted Schizophrenic Patients [NCT00295412]Phase 40 participants InterventionalCompleted
A Randomized, Double-Blind, Parallel-Group, Fixed Dose, Clinical Trial of Quetiapine 600 mg/Day vs 1200 mg/Day for Patients With Treatment-Resistant Schizophrenia or Schizoaffective Disorder [NCT00297947]Phase 2/Phase 360 participants (Actual)Interventional2004-12-31Completed
A Multi-center, Randomized, Open, Treatment-switching Study From Orally Administered Antipsychotic Monotherapy in the Treatment of Chronic Schizophrenic and Schizoaffective Patients [NCT00304616]Phase 4500 participants Interventional2004-10-31Completed
Duration of Maintenance Anti-psychotic Therapy After First -Episode Schizophrenia: a Double-blind Randomized Placebo-control Relapse Prevention Study [NCT00334035]Phase 4169 participants (Actual)Interventional2003-08-31Completed
A Multi-Centre,Double-Blind,Randomised-Withdrawal,Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine SR as Monotherapy in the Maintenance Treatment of Patients With GAD Following an Open-Label Stabilisation Period [NCT00314210]Phase 3575 participants Interventional2006-03-31Completed
An Open-Label, Randomised, 2-Period, 2-Treatment, 2-sequence, Crossover, Steady State Bioequivalence Study of Quetiapine Fumarate 300 mg Tablets [Test Formulation; Torrent Pharmaceuticals Ltd., India] Versus Seroquel® 300 mg Tablet [Reference Formulation; [NCT01634373]Phase 10 participants InterventionalCompleted
An Open-Label, Randomised, 2-Period, 2-Treatment, 2-sequence, Crossover, Single-dose Bioequivalence Study of Quetiapine 25 mg Tablet [Test Formulation; Torrent Pharmaceuticals Ltd., India] Versus Seroquel® 25 mg Tablet [Reference Formulation; AstraZeneca, [NCT01634386]Phase 10 participants InterventionalCompleted
An Open-Label, Randomised, 2-Period, 2-Treatment, 2-sequence, Crossover Single-dose Bioequivalence Study of Quetiapine 25 mg Tablet [Test Formulation; Torrent Pharmaceuticals Ltd., India] Versus Seroquel® 25 mg Tablet [Reference Formulation; AstraZeneca, [NCT01634399]Phase 10 participants InterventionalCompleted
[NCT03007303]30 participants (Anticipated)Observational [Patient Registry]2016-06-30Recruiting
A Pilot Study on the Safety, Tolerability, and Effectiveness of Quetiapine in Postpartum Depression [NCT04950868]Phase 130 participants (Anticipated)Interventional2022-03-18Recruiting
Quetiapine as a Prophylactic Agent for Early Postoperative Delirium in High Risk Patients in Open Heart Surgeries [NCT05801289]60 participants (Anticipated)Interventional2022-12-04Recruiting
A Longitudinal Comparison of Aripiprazole vs. Higher Metabolic Risk Antipsychotic Drugs on Adiposity Using MRI [NCT01739127]83 participants (Actual)Observational2012-11-30Completed
Randomized Multicentric Open-label Phase III Clinical Trial to Evaluate the Efficacy of Continual Treatment Versus Discontinuation Based in the Presence of Prodromes in a First Episode of Non-affective Psychosis. [NCT01765829]Phase 3104 participants (Anticipated)Interventional2012-11-30Recruiting
Randomized Controlled Trial Comparing Haloperidol, Quetiapine and Placebo in the Pharmacological Treatment of Delirium : The Haloquet Trial [NCT01811459]Phase 3107 participants (Actual)Interventional2013-02-28Completed
Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building [NCT04446234]Phase 4350 participants (Anticipated)Interventional2021-05-31Not yet recruiting
Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction in Patients Undergoing High-dose Antipsychotic Therapy [NCT03019887]139 participants (Actual)Interventional2011-04-30Completed
A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator Controlled Trial of Flexible-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial [NCT01727726]Phase 32,182 participants (Actual)Interventional2012-12-31Completed
Phase 2 Study of FK949E - Double-blind, Placebo-controlled, Comparative Study in Major Depressive Disorder Patients With Inadequate Response to Existing Antidepressants [NCT01725282]Phase 2172 participants (Actual)Interventional2011-12-14Completed
Comparative Safety, Tolerability, and Effectiveness of Lithium Versus Quetiapine in Patients Across the Spectrum of Bipolar Disorder [NCT01526148]Phase 442 participants (Actual)Interventional2012-01-31Terminated(stopped due to Ran out of funding)
A Prospective, Sixteen-Week, Double-Blind, Placebo-Controlled, Trial of Seroquel in Combination With Treatment as Usual in Patients With GAD and Remitted Comorbid Opiate Dependence [NCT00668265]Phase 414 participants (Actual)Interventional2008-01-31Terminated(stopped due to The study was not completed, the funding sponsor lost interest.)
A Randomized, Double-blind, Active Comparator-Controlled Study to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia [NCT04115319]Phase 3475 participants (Actual)Interventional2019-11-15Completed
A Randomised, Controlled Trial to Investigate the Effect of an Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment. [NCT05603104]Phase 31,254 participants (Anticipated)Interventional2023-08-01Not yet recruiting
Brain Imaging of Quetiapine Response in Anxious Depression [NCT00982345]Phase 420 participants (Actual)Interventional2009-03-31Completed
Phase I Study of FK949E - Phase I Oral Multiple-dose Study in Patients With Major Depressive Disorder [NCT01924520]Phase 132 participants (Actual)Interventional2010-11-30Completed
Pharmacokinetics of Quetiapine Across Pregnancy and Postpartum [NCT02978534]4 participants (Actual)Observational2016-03-31Completed
Phase IV Study of Quetiapine XR Aimed at Disability and Cognitive Impairments. [NCT00746421]Phase 432 participants (Actual)Interventional2010-01-31Terminated(stopped due to Sponsor withdrew funding)
Trazodone vs. Quetiapine for the Treatment of ICU Delirium: A Prospective Observational Pilot Study [NCT05307003]60 participants (Anticipated)Observational2023-04-01Recruiting
Effects of Sleep Disorders and Sedative-hypnotic Medications on Health-related Quality of Life in Chronic Kidney Disease Patients [NCT05240261]Phase 160 participants (Anticipated)Interventional2022-05-01Not yet recruiting
A Practical, Pilot, Randomized, Controlled Trial of Valproate Alone or in Combination With Quetiapine for Severe COVID-19 Pneumonia With Agitated Delirium [NCT04513314]Phase 40 participants (Actual)Interventional2023-03-28Withdrawn(stopped due to coronavirus omicron variant infection typically not associated with delirium and agitation severely hampered recruitment.)
Efficacy of Quetiapine in Treating Patients With Active Substance Use Disorder and Schizophrenia [NCT00156715]Phase 423 participants (Actual)Interventional2004-03-31Completed
A Randomised Pragmatic Trial Comparing the Clinical and Cost Effectiveness of Lithium and Quetiapine Augmentation in Treatment Resistant Depression [NCT03004521]Phase 4276 participants (Anticipated)Interventional2016-11-30Recruiting
Comparison of Quetiapine and Trazodone Treatment for Insomnia in Dually Diagnosed Veterans: an Open (e.g. Unblinded) Randomized Stay-Switch Pilot Trial [NCT01662297]Phase 41 participants (Actual)Interventional2012-07-31Terminated(stopped due to it became clear that recruitment was infeasible)
Quetiapine Pharmacotherapy for Cannabis Dependence [NCT01697709]Phase 2130 participants (Actual)Interventional2012-10-01Completed
Divalproex Extended Release and Placebo, Lithium, or Quetiapine for Mania [NCT00183443]Phase 375 participants (Actual)Interventional2005-02-28Completed
CSP #2015 - Multicenter, Randomized, Double-blind Comparator Study of Antipsychotics Pimavanserin and Quetiapine for Parkinson''s Disease Psychosis (C-SAPP) [NCT04373317]Phase 4358 participants (Anticipated)Interventional2022-10-24Recruiting
"Observational Study on the Effect of Switch to Lurasidone or Other Antipsychothics on Metabolic and Weight Changes in Subjects With Schizophrenia" [NCT04312503]95 participants (Actual)Observational2020-07-13Completed
A 6-Month, Multicenter, Double-Blind, Randomized, Flexible-Dose, Parallel-Group Study to Compare the Efficacy, Safety, and Tolerability of JNJ-42847922 Versus Quetiapine Extended-Release as Adjunctive Therapy to Antidepressants in Adult Subjects With Majo [NCT03321526]Phase 2107 participants (Actual)Interventional2017-12-12Completed
A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalency Study of Quetiapine Fumarate 25 mg Tablets Under Fed Conditions [NCT01570894]42 participants (Actual)Interventional2007-07-31Completed
A Single Dose, Two-Period, Two-Treatment, Two-Sequence Crossover Bioequivalency Study of Quetiapine Fumarate 25 mg Tablets Under Fasting Conditions [NCT01570907]42 participants (Actual)Interventional2007-06-30Completed
A Two Period, Two Treatment, Two Way, Steady State Crossover Bioequivalence Study of Quetiapine Fumarate 300 mg Tablets Under Fasting Conditions [NCT01570959]56 participants (Actual)Interventional2007-04-30Completed
Quetiapine Plus Topiramate or Placebo for Bipolar Mania & Cannabis Use in Adolescents [NCT00393978]Phase 475 participants (Actual)Interventional2006-11-30Completed
A Single-Blind, Randomized, Naturalistic Pilot Study, Comparison of Divalproex ER and Quetiapine for Adults With Acute Mania or Mixed Episodes [NCT00397020]Phase 430 participants (Actual)Interventional2006-12-31Completed
Quetiapine Augmentation to SRIs for Patients With Obsessive Compulsive Disorder, a Double-blind, Placebo-controlled Study [NCT00318539]Phase 290 participants Interventional2003-12-31Completed
An International, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate (Seroquel SR™ ) in the Treatment of Generalized Anxiety Disorder (SILV [NCT00322595]Phase 3800 participants (Anticipated)Interventional2006-05-31Completed
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo- Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) in Combination With an Antidepressant in the Treatment of Patients With Major [NCT00326105]Phase 3450 participants (Anticipated)Interventional2006-04-30Completed
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SR®) as Mono-Therapy in the Treatment of Adult Patients With Major Depressive Disorde [NCT00326144]Phase 3310 participants (Actual)Interventional2006-04-30Completed
A Sequential and Parallel Cohort Design to Test the Clinical Utility of Antipsychotic Medication Levels in Plasma as Determined by Liquid Chromatography-Tandem Mass Spectrometry [NCT02462473]Phase 29 participants (Actual)Interventional2015-05-31Terminated(stopped due to Due to poor enrollment sponsor terminated early after enrolling 9 in Cohort 1 and no enrollment in Cohorts 2 and 3.)
Study of FK949E - An Open-label, Two-way Crossover Study to Evaluate the Effects of Switching Different Strength Forms of FK949E in Bipolar Disorder Patients With Major Depressive Episodes [NCT02362412]Phase 322 participants (Actual)Interventional2015-02-18Completed
Long-term Study of FK949E in Elderly Patients -Long-term Study in Elderly Bipolar Disorder Patients With Major Depressive Episodes- [NCT01737268]Phase 320 participants (Actual)Interventional2012-10-29Completed
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo Controlled, Phase III Study of the Efficacy and Safety of Quetiapine Fumarate (SEROQUEL®) Sustained-Release as Monotherapy in Adult Patients With Acute Bipolar Mania [NCT00422123]Phase 3447 participants (Actual)Interventional2007-01-31Completed
An Open-Label Study of Quetiapine Added to Oros Methylphenidate in the Treatment of ADHD and Aggressive Behavior [NCT00550147]Phase 230 participants (Actual)Interventional2004-02-29Completed
An Open Label, Randomized, Flexible Dose, 6-week Clinical Trial of the Safety and Efficacy of Divalproex ER vs Quetiapine in the Treatment of Behavioral Symptoms in the Elderly With Moderate to Severe Alzheimer's Dementia [NCT00375557]Phase 40 participants (Actual)Interventional2006-10-31Withdrawn
Efficacy of Quetiapine for Pediatric Delirium [NCT02056171]Phase 1/Phase 26 participants (Actual)Interventional2015-03-31Terminated(stopped due to Unable to recruit subjects at our site within the past year.)
Using 18F-FPEB PET to Identify mGLUR5 Availability in Affective Disorders [NCT05840861]59 participants (Anticipated)Observational2020-11-05Recruiting
A Phase 3 Randomized, Double-Blind, Active-controlled Study to Evaluate the Efficacy and Safety of Lurasidone in Acutely Psychotic Patients With Schizophrenia [NCT03465787]Phase 3210 participants (Actual)Interventional2018-04-09Completed
Developing a Single Patient Open-label Trial Tapering Algorithm for Antipsychotics in Long-Term Care - A Pilot Study [NCT02958800]20 participants (Anticipated)Interventional2016-12-31Recruiting
A Pragmatic Randomized Trial Comparing Antipsychotics in Lewy Body Disease [NCT05590637]Phase 494 participants (Anticipated)Interventional2022-04-22Recruiting
Quetiapine for Bipolar Disorder and Alcohol Dependence [NCT00457197]Phase 490 participants (Actual)Interventional2007-03-31Completed
Efficacy of Hydroxyzine Versus Treatment as Usual for Panic Disorder: An Eight-Week, Open Label, Pilot, Randomized Controlled Trial. [NCT05737511]Phase 480 participants (Anticipated)Interventional2023-12-30Not yet recruiting
Open Label, Non-randomised, Single Arm, Phase IIIB Switch Study: Evaluating the Clinical Benefits of Quetiapine XR in Patients With Schizophrenia and Anxiety Disorder. [NCT01672554]Phase 340 participants (Anticipated)Interventional2008-12-31Active, not recruiting
Pharmacovigilance in Gerontopsychiatric Patients [NCT02374567]Phase 3407 participants (Actual)Interventional2015-01-31Terminated
An Open-Label, Sequential Study of Quetiapine Fumarate Extended Release (XR) and Mirtazapine for the Treatment of Alcohol Dependency in Very Heavy Drinkers [NCT01165541]Phase 220 participants (Actual)Interventional2010-09-30Completed
Sequential Multiple Assignment Randomized Treatment (SMART) for Bipolar Disorder [NCT01588457]Phase 4112 participants (Actual)Interventional2011-06-30Completed
Drug Use-results Survey on Quetiapine Extended-release Tablets in Patients With Depression in Bipolar Disorder [NCT03403790]369 participants (Actual)Observational2018-01-15Completed
Quetiapine Compared With Placebo in the Management of Fibromyalgia [NCT01458964]Phase 442 participants (Actual)Interventional2008-01-31Completed
Comparison of Trazodone vs Quetiapine vs Placebo for the Treatment of ICU Delirium: A Randomized Controlled Trial (The TraQ Study) [NCT05085808]Phase 430 participants (Anticipated)Interventional2024-03-01Not yet recruiting
A Comparison Study of the Efficacy of a Rapid Titration of Quetiapine and Haloperidol in Agitated Adults in an Emergency Setting. [NCT00457366]Phase 472 participants (Actual)Interventional2006-05-31Completed
A Phase 2, Double-Blind, Placebo Controlled Trial to Assess the Efficacy of Quetiapine Fumarate Extended Release for the Treatment of Alcohol Dependence in Very Heavy Drinkers. [NCT00498628]Phase 2224 participants (Actual)Interventional2007-12-31Completed
Phase II/III Study of FK949E: Placebo-controlled, Double-blind, Parallel-group Comparative Study and Open-label, Non-controlled Extension Study in Bipolar Disorder Patients With Major Depressive Episodes [NCT01725308]Phase 2/Phase 3431 participants (Actual)Interventional2012-02-07Completed
A Randomized, Double-blind, Placebo-controlled Study of Quetiapine SR and Divalproex Sodium ER on Anxiety in Bipolar Disorder With at Least Moderately Severe Current Anxiety and Lifetime Panic or Generalized Anxiety Disorder. [NCT00579280]Phase 4224 participants (Actual)Interventional2007-07-31Completed
A Phase 3 Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Clinical Trial to Study the Efficacy and Safety of Two Doses of Lurasidone in Acutely Psychotic Subjects With Schizophrenia (PEARL 3) [NCT00790192]Phase 3488 participants (Actual)Interventional2008-10-31Completed
Double-blind, Randomized, Active Controlled Study of the Efficacy and Safety of Extended-release Quetiapine Fumarate (Seroquel XR) as Adjunctive Medication Therapy to Cognitive Behavioral Therapy in the Treat,Ent of Patients With Comorbid Major Depression [NCT01971203]62 participants (Actual)Interventional2009-09-30Completed
Mirtazapine and Quetiapine as Treatment for Postoperative Sleep Disturbance After Fast-track Knee Replacement [NCT04728581]165 participants (Anticipated)Interventional2024-01-01Not yet recruiting
A Randomized Controlled Trial of Quetiapine for the Treatment of Youth With Co-occurring Substance Use Disorders and Severe Mood Dysregulation [NCT02845453]Phase 424 participants (Actual)Interventional2017-01-20Completed
1/2-MC4R Genotype and Pediatric Antipsychotic Drug- Induced Weight Gain [NCT01844700]Phase 414 participants (Actual)Interventional2013-07-31Terminated(stopped due to very slow recruitment, no sufficient results)
Clinical Management of Metabolic Problems in Patients With Schizophrenia [NCT00423878]Phase 4215 participants (Actual)Interventional2007-01-31Completed
Quetiapine Plus Topiramate or Placebo for Bipolar Mania & Alcohol Use in Adolescents & Young Adults [NCT00550394]Phase 456 participants (Actual)Interventional2008-04-30Completed
An Open Label Study of Seroquel SR® (Quetiapine) for the Treatment of Refractory and Treatment Resistant Functional Bowel Disorders [NCT00617396]25 participants (Actual)Interventional2008-02-29Completed
A Double-Blind, Placebo-Controlled Trial of the Efficacy of Quetiapine for the Reduction of Cocaine Use [NCT00631748]60 participants (Actual)Interventional2008-02-29Completed
An Open-label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines in Treatment-refractory Patients With Unipolar Depression or Generalized Anxiety Disorder and Chronic Benzodiazepine Use [NCT01244711]Phase 41 participants (Actual)Interventional2008-09-30Terminated(stopped due to Terminated: recruiting or enrolling participants has halted prematurely)
Improving Metabolic Parameters of Antipsychotic Child Treatment (IMPACT) [NCT00806234]Phase 4127 participants (Actual)Interventional2009-01-31Completed
Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-reference, Flexible-dose Study of Brexpiprazole in Patients With Acute Schizophrenia [NCT01810380]Phase 3468 participants (Actual)Interventional2013-03-31Completed
Phase IV Study of the Effectiveness of Aripiprazole, Quetiapine, and Ziprasidone in the Treatment of First Episode of Non-affective Psychosis Individuals Included in the First Episode Psychosis Clinical Program II (PAFIP II) [NCT02305823]Phase 4203 participants (Actual)Interventional2005-10-31Completed
Program to Study the Experience of Using Seroquel ® in Patients With Bipolar Disorder of the First and Second Types in Remission With Signs of Impaired Impulse Control [NCT05098353]30 participants (Anticipated)Interventional2021-04-10Recruiting
NMDA Antagonists in Bipolar Depression [NCT01833897]Phase 48 participants (Actual)Interventional2013-03-31Completed
Cognitive Control and Functional Connectivity During Resting State in Patients With Heightened Risk of Bipolar Disorder - a Quetiapine Challenge [NCT02451306]54 participants (Anticipated)Interventional2015-06-30Not yet recruiting
Effectiveness of Switching Antipsychotic Medications [NCT00044655]Phase 4219 participants (Actual)Interventional2001-07-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00044655 (1) [back to overview]Number Who Discontinued Medication Within First 6 Study Months
NCT00113295 (5) [back to overview]Remission (HAM-A ≤ 7)
NCT00113295 (5) [back to overview]Response, Clinical Global Impression of Improvement (CGI-I)
NCT00113295 (5) [back to overview]Depressive Symptoms, Montgomery-Asberg Depression Rating Scale (MADRS)
NCT00113295 (5) [back to overview]Hamilton Anxiety Scale (HAM-A) Score at Study Endpoint.
NCT00113295 (5) [back to overview]The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).
NCT00156715 (2) [back to overview]Mean Number of Drinking Days Per Week
NCT00156715 (2) [back to overview]Clinical Symptoms
NCT00177164 (4) [back to overview]Evaluate the Number of Clinical Events (Pooled) Occurring Between 3-15 Months Following a Switch/Stabilization of the Antipsychotic Agents Among Patients Who Receive Either Risperidal Consta or One of the 4 Marketed 2nd Generation Antipsychotic Agents.
NCT00177164 (4) [back to overview]Number of Participants With Treatment Emergent Hyperlipidemia
NCT00177164 (4) [back to overview]Number of Participants With Treatment - Emergent Hyperglycemia
NCT00177164 (4) [back to overview]BMI
NCT00181883 (1) [back to overview]Change in Bipolar Symptoms as Measured by Reduction in Young-Mania Rating Scale (Y-MRS) Total Score
NCT00183443 (5) [back to overview]Symptoms of Mania, as Measured by Young Mania Rating Scale
NCT00183443 (5) [back to overview]Global Assessment of Functioning
NCT00183443 (5) [back to overview]Clinical Global Impression Scale for Bipolar Disorder (CGI-BD)
NCT00183443 (5) [back to overview]Hamilton Rating Scale for Depression (HAM-D,17)
NCT00183443 (5) [back to overview]Social and Occupational Functioning Assessment Scale (SOFAS)
NCT00186043 (3) [back to overview]Percentage of Participants With Clinical Global Impression for Bipolar Disorders Overall Severity Remission (Score <=2 at Week 8)
NCT00186043 (3) [back to overview]Percentage of Participants With >=50% Improvement From Baseline in Clinical Global Impression for Bipolar Disorders Overall Severity
NCT00186043 (3) [back to overview]Percentage of Participants With 50% Improvement From Baseline in Both Montgomery Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) Scores
NCT00206102 (15) [back to overview]Change in Personal Evaluation of Transitions in Treatment (PETiT) Total Score
NCT00206102 (15) [back to overview]Change in Simpson-Angus Scale (SAS) Total Score
NCT00206102 (15) [back to overview]Presence of a Posterior Subcapsular (P) Type Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale
NCT00206102 (15) [back to overview]Change in Barnes Akathisia Rating Scale (BARS) Global Score
NCT00206102 (15) [back to overview]Change in the PANSS Psychopathology Subscale Score
NCT00206102 (15) [back to overview]Change in Abnormal Involuntary Movement Scale (AIMS) Total Score
NCT00206102 (15) [back to overview]Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q SF) Total Score
NCT00206102 (15) [back to overview]Change in the PANSS Negative Subscale Score
NCT00206102 (15) [back to overview]Change in the PANSS Positive Subscale Score
NCT00206102 (15) [back to overview]Change in the Positive and Negative Syndrome Scale (PANSS) Total Score
NCT00206102 (15) [back to overview]Number of Participants With Potential Extrapyramidal Symptoms (EPS)
NCT00206102 (15) [back to overview]Number of Relapses of Schizophrenia or Schizoaffective Disorder
NCT00206102 (15) [back to overview]Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score
NCT00206102 (15) [back to overview]Presence of a Cortical (C) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the Lens Opacities Classification System II (LOCS II ) Grading Scale
NCT00206102 (15) [back to overview]Presence of a Nuclear Opalescence (N) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale
NCT00216476 (5) [back to overview]Mean Relapse Free Period(Risperidone LAI Versus Quetiapine)
NCT00216476 (5) [back to overview]Mean Relapse Free Period (Exploratory/Aripiprazole)
NCT00216476 (5) [back to overview]Change From Baseline to Endpoint in Total Positive and Negative Syndrome Scale (PANSS) Score
NCT00216476 (5) [back to overview]Change From Baseline to Endpoint in Clinical Global Impression Scale (CGI) Score
NCT00216476 (5) [back to overview]Change From Baseline to Endpoint in Short-Form Health Survey 12 (SF-12) Scores
NCT00227305 (11) [back to overview]Number of Patients Withdrawn Due to AEs.
NCT00227305 (11) [back to overview]Categorical Change From OL Baseline to Week 26 in Simpson-Angus Scale (SAS)Total Score
NCT00227305 (11) [back to overview]Categorical Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Score
NCT00227305 (11) [back to overview]Incidence and Nature of Adverse Events (AEs)
NCT00227305 (11) [back to overview]Changes in Tanner Stage
NCT00227305 (11) [back to overview]Changes in Laboratory Test Results (Prolactin)
NCT00227305 (11) [back to overview]Change From OL Baseline in Supine Systolic BP.
NCT00227305 (11) [back to overview]Change From OL Baseline in Supine Diastolic BP.
NCT00227305 (11) [back to overview]Change From Baseline in Weight
NCT00227305 (11) [back to overview]Change From Baseline in Supine Pulse
NCT00227305 (11) [back to overview]Change From Baseline in Children's Global Assessment Scale (CGAS) Score
NCT00292370 (9) [back to overview]Change in Mean Q-LES-Q Score From Baseline to Endpoint.
NCT00292370 (9) [back to overview]Change in Mean Sheehan Disability Scale (SDS) Scores From Baseline to Endpoint.
NCT00292370 (9) [back to overview]Change in Mean Scores of Pittsburgh Sleep Quality Index (PSQI) From Baseline to Endpoint.
NCT00292370 (9) [back to overview]Change in CGI-I
NCT00292370 (9) [back to overview]Change in Clinician-Administered PTSD Scale for DSM-IV Total Score.
NCT00292370 (9) [back to overview]Change in Arizona Sexual Experience Scale (ASEX)
NCT00292370 (9) [back to overview]Change in Mean PANSS Total and Subscores From Baseline to Endpoint
NCT00292370 (9) [back to overview]Change in Total Mean Hamilton Rating Scale for Depression (HAMD) Scores
NCT00292370 (9) [back to overview]Change in Total Mean Davidson Trauma Scale (DTS)
NCT00330863 (3) [back to overview]Substantial Clinical Deterioration Measured by Psychotic Symptoms
NCT00330863 (3) [back to overview]Number of Patients Discontinuing From the Study
NCT00330863 (3) [back to overview]Side Effects and Metabolic Measures
NCT00388973 (8) [back to overview]Change From Baseline in Suicidal Thoughts as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Item 10
NCT00388973 (8) [back to overview]Tolerability as Measured by Adverse Event Withdrawals During Treatment
NCT00388973 (8) [back to overview]Change From Baseline in Somatic Symptoms Cluster From the Hamilton Anxiety Scale (HAM-A)
NCT00388973 (8) [back to overview]Change From Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index
NCT00388973 (8) [back to overview]Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 9.
NCT00388973 (8) [back to overview]Change From Baseline in Health-related Quality of Life, Enjoyment and Satisfaction (Q-LES-Q)
NCT00388973 (8) [back to overview]Change From Baseline in Anxiety Symptoms Measured by Hamilton Anxiety 14 Item Scale (HAM-A)
NCT00388973 (8) [back to overview]Change From Baseline for Satisfaction With Medication From Quality of Life, Enjoyment, Satisfaction Questionaire (Q-LES-Q)
NCT00389064 (11) [back to overview]Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score
NCT00389064 (11) [back to overview]Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score
NCT00389064 (11) [back to overview]Hamilton Rating Scale for Anxiety (HAM-A) Response.
NCT00389064 (11) [back to overview]Number of Patients Reaching Hamilton Rating Scale for Anxiety (HAM-A) Remission
NCT00389064 (11) [back to overview]Safety and Well Tolerated as Measured by Extra Pyramidal Symptoms (EPS)
NCT00389064 (11) [back to overview]Safety and Well Tolerated as Measured in Adverse Event
NCT00389064 (11) [back to overview]Change in Health-related Quality of Life as Measured by Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Percent Maximum Total Score
NCT00389064 (11) [back to overview]Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score
NCT00389064 (11) [back to overview]Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score
NCT00389064 (11) [back to overview]Change in Montgomery-Asberg Depression Rating Scale (MADRS)
NCT00389064 (11) [back to overview]Change in the Visual Analogue Scale (VAS) Measuring Pain
NCT00393978 (2) [back to overview]Change in Percent Days of Cannabis Use Per Week
NCT00393978 (2) [back to overview]Change in Joints Per Week
NCT00397020 (1) [back to overview]Primary Measure: Young Mania Rating Scale (YMRS) Primary Endpoint: Day 7
NCT00411463 (4) [back to overview]Number of Participants With a Response
NCT00411463 (4) [back to overview]Quality of Life (QOL) Collected Using the Q-LES-Q (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form)
NCT00411463 (4) [back to overview]Number of Participants With Greater Than or Equal to 50% Reduction in Depression Scores, With a Mania Score Less Than or Equal to 10
NCT00411463 (4) [back to overview]Descriptive Measures of the Feasibility of IPSRT-BPII
NCT00423878 (2) [back to overview]Efficacy Failure, Defined as Psychiatric Hospitalization, a 25 Percent Increase From Baseline on the Positive and Negative Syndrome Scale or Substantial Clinical Deterioration on the Clinical Global Impressions-Change (CGI-C)
NCT00423878 (2) [back to overview]Change in Non-HDL Cholesterol Level for Patients Assigned to Stay and Patients Assigned to Switch Over 24 Weeks
NCT00434876 (4) [back to overview]Insomnia Severity Index (ISI)
NCT00434876 (4) [back to overview]Pittsburgh Sleep Quality Index (PSQI)
NCT00434876 (4) [back to overview]Wake After Sleep Onset Time (WASO) From an In-laboratory Polysomnogram.
NCT00434876 (4) [back to overview]Sleep Efficiency (From an In-laboratory Polysomnogram)
NCT00457197 (9) [back to overview]The Number of Standard Drinks/Day Will Serve as the Primary Outcome Measure.
NCT00457197 (9) [back to overview]Young Mania Rating Scale (YMRS)
NCT00457197 (9) [back to overview]Aspartate Aminotransferase (AST)
NCT00457197 (9) [back to overview]Alanine Aminotransferase (ALT)
NCT00457197 (9) [back to overview]Gamma-glutamyltransferase (GGT)
NCT00457197 (9) [back to overview]Hamilton Rating Scale for Depression (HRSD)
NCT00457197 (9) [back to overview]Inventory of Depressive Symptomatology-Self Report (IDS-SR)
NCT00457197 (9) [back to overview]Penn Alcohol Craving Scale (PACS)
NCT00457197 (9) [back to overview]Percent of Heavy Drinking Days
NCT00457366 (1) [back to overview]Change in the PANSS-EC Score Among Participants From Baseline to 2 Hours After Administration of the Medication.
NCT00498628 (14) [back to overview]Hamilton Anxiety Scale (HAM-A)
NCT00498628 (14) [back to overview]Drinks Per Drinking Day
NCT00498628 (14) [back to overview]Drinks Per Day
NCT00498628 (14) [back to overview]Drinking Consequences Score
NCT00498628 (14) [back to overview]Percent Subjects Abstinent
NCT00498628 (14) [back to overview]Quality of Life SF-12 - Physical Aggregate Score
NCT00498628 (14) [back to overview]Percent Subjects With no Heavy Drinking Day
NCT00498628 (14) [back to overview]Quality of Life SF - 12 - Mental Aggregate Score
NCT00498628 (14) [back to overview]Percent Very Heavy Drinking Day
NCT00498628 (14) [back to overview]Pittsburgh Sleep Quality Score
NCT00498628 (14) [back to overview]Percent Heavy Drinking Days
NCT00498628 (14) [back to overview]Percent Days Abstinent
NCT00498628 (14) [back to overview]Penn Alcohol Craving Score (PACS_
NCT00498628 (14) [back to overview]Montgomery-Asberg Depression Rating Scale (MADRS)
NCT00508157 (2) [back to overview]Number of Participants Remaining on Metabolic Syndrome at Week 16
NCT00508157 (2) [back to overview]Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (HDL) Cholesterol at Week 16
NCT00509067 (3) [back to overview]Clinical Global Impression
NCT00509067 (3) [back to overview]MATRICS Verbal Learning and Memory
NCT00509067 (3) [back to overview]Negative Symptoms Measured on Positive and Negative Syndrome Scale (PANSS)
NCT00515723 (2) [back to overview]DEXA Total Fat
NCT00515723 (2) [back to overview]Clamp Derived Insulin Sensitivity (mg/kg/Min)
NCT00518973 (5) [back to overview]Differences in Scores on the HAM-D (Hamilton Depression Rating Scale)
NCT00518973 (5) [back to overview]Difference in Scores on the STAI (State-Trait Anxiety Inventory)
NCT00518973 (5) [back to overview]Differences in Scores on the PANNSS (The Positive and Negative Syndrome Scale)
NCT00518973 (5) [back to overview]Hours Occupied by Preoccupations and Rituals Assessed by Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS)
NCT00518973 (5) [back to overview]Difference in Scores on the EDI-2 (Eating Disorders Inventory)
NCT00521365 (14) [back to overview]Change in the Quality of Life Questionnaire EQ5D Index From Baseline to End of the Study.
NCT00521365 (14) [back to overview]Change in the Clinical Global Impression (CGI) Total Score From Baseline (CGI-S) to Final Visit or Last Observation Carried Forward (LOCF)(CGI-I).
NCT00521365 (14) [back to overview]Change in the Clinical Global Impression - Improvement (CGI-I) at Final Visit or Last Observation Carried Forward (LOCF).
NCT00521365 (14) [back to overview]Change in the Barnes Akathisia Rating Scale (BARS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF).
NCT00521365 (14) [back to overview]Change in Weight From Baseline to Final Visit or Last Observation Carried Forward (LOCF).
NCT00521365 (14) [back to overview]Change in Waist Circumference From Baseline to Final Visit or Last Observation Carried Forward (LOCF).
NCT00521365 (14) [back to overview]Number of Participants With Young Mania Rating Scale (YMRS) Response at Final Visit or Last Observation Carried Forward (LOCF)
NCT00521365 (14) [back to overview]Number of Participants With Young Mania Rating Scale (YMRS) Remission at Final Visit or Last Observation Carried Forward (LOCF).
NCT00521365 (14) [back to overview]Number of Participants With >7% Increase in Weight
NCT00521365 (14) [back to overview]Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 3
NCT00521365 (14) [back to overview]Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 2.
NCT00521365 (14) [back to overview]Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to End of Treatment (Day 21)
NCT00521365 (14) [back to overview]Change in the Simpson-Angus Scale (SAS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF).
NCT00521365 (14) [back to overview]Change in the Quality of Life Questionnaire EQ5D Visual Analogue Scale (VAS) From Baseline to Final Visit or Last Observation Carried Forward (LOCF).
NCT00534599 (15) [back to overview]Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score
NCT00534599 (15) [back to overview]Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8
NCT00534599 (15) [back to overview]Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 1
NCT00534599 (15) [back to overview]Number of Patients With HAM-A Remission (Total Score ≤7) at Week 8
NCT00534599 (15) [back to overview]"Number of Patients With Clinical Global Impression-Global Improvement (CGI-I) Score of Much/Very Much Improved at Week 8"
NCT00534599 (15) [back to overview]Least Square Mean Change From Randomization to Week 1 in CGI-S Score
NCT00534599 (15) [back to overview]Least Square Mean Change From Randomization to Week 1 in HAM-A Psychic Anxiety Subscale Score
NCT00534599 (15) [back to overview]Mean Change From Randomization to Week 8 in Q-LES-Q Item 15 (Satisfaction With Medication) Score
NCT00534599 (15) [back to overview]Least Square Mean Change From Randomization to Week 1 in HAM-A Somatic Anxiety Subscale Score
NCT00534599 (15) [back to overview]Least Square Mean Change From Randomization to Week 8 in Clinical Global Impression-Severity of Illness (CGI-S) Score
NCT00534599 (15) [back to overview]Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score
NCT00534599 (15) [back to overview]Least Square Mean Change From Randomization to Week 8 in Quality of Life Enjoyment and Satisfaction Questionaire (Q-LES-Q) Percent Maximum Total Score
NCT00534599 (15) [back to overview]Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score
NCT00534599 (15) [back to overview]Least Square Mean Change From Randomization to Week 1 in HAM-A Total Score
NCT00534599 (15) [back to overview]Mean Change From Randomization to Week 8 in Q-LES-Q Item 16 (Overall Quality of Life) Score
NCT00550147 (5) [back to overview]Swanson, Nolan and Pelham IV (SNAP-IV) Oppositional-Defiant Disorder Subscale
NCT00550147 (5) [back to overview]CGI-S: Clinical Global Improvement Scale
NCT00550147 (5) [back to overview]RAAPP: Rating of Aggression Against People and/or Property Scale
NCT00550147 (5) [back to overview]Attention Deficit/Hyperactivity Disorder Rating Scale -IV- Parent Version (ADHDRS-IV-Parent Version)
NCT00550147 (5) [back to overview]Modified Overt Aggression Scale (MOAS)
NCT00550394 (4) [back to overview]Drinks Per Day
NCT00550394 (4) [back to overview]Drinks Per Drinking Day
NCT00550394 (4) [back to overview]Percent Heavy Drinking Days
NCT00550394 (4) [back to overview]Percentage of Days Abstinent
NCT00579280 (11) [back to overview]Change From Baseline on Sheehan- Suicidality Tracking Scale S-STS (2008 Version With 8 Items)
NCT00579280 (11) [back to overview]Change From Baseline in Hamilton Anxiety Scale (HAM-A) Scores
NCT00579280 (11) [back to overview]Change From Baseline on Patient Global Improvement Scale (PGI-21) for Anxiety Symptoms
NCT00579280 (11) [back to overview]Change From Baseline on Montgomery Asberg Depression Rating Scale (MADRS)
NCT00579280 (11) [back to overview]Change From Baseline on Sheehan Disability Scale (SDS) - Total
NCT00579280 (11) [back to overview]Change From Baseline on Clinician Global Impression Scale for Bipolar Disorder (CGI-BP) (Overall Severity)
NCT00579280 (11) [back to overview]Change From Baseline on Rapid Ideas Scale (RISc)
NCT00579280 (11) [back to overview]Change From Baseline in Young Mania Rating Scale (YMRS)
NCT00579280 (11) [back to overview]Change From Baseline in the CGI-21 Anxiety
NCT00579280 (11) [back to overview]Change From Baseline in Sheehan Panic Disorder Scale (SPS)
NCT00579280 (11) [back to overview]Change From Baseline in Sheehan Irritability Scale (SIS)
NCT00600756 (31) [back to overview]The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Extra-pyramidal Events at Month 12 in the Safety Population
NCT00600756 (31) [back to overview]The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants at Month 12 in the Safety Population With Individual Symptoms Assessed by the Modified UKU: Hyperprolactinaemia in Women
NCT00600756 (31) [back to overview]The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants at Month 12 in the Safety Population With Individual Symptoms Assessed by the Modified UKU: Sexual Dysfunction in Men
NCT00600756 (31) [back to overview]The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Discontinued the Study Because of an TEAE at Month 12 in the Safety Population
NCT00600756 (31) [back to overview]The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Had at Least 1 Cardiac TEAE at Month 12 in the Safety Population
NCT00600756 (31) [back to overview]The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Had at Least 1 Extra-pyramidal TEAE at Month 12 in the Safety Population
NCT00600756 (31) [back to overview]The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants With a Treatment-emergent Adverse Event (TEAEs) at Month 12 in the Safety Population
NCT00600756 (31) [back to overview]The Safety and Tolerability of Quetiapine XR vs Risperidone by Evaluating the Number of Participants at Month 12 in Safety Population With Individual Symptoms Assessed by the Modified Udvalg for Kliniske Undersogelser, Side Effect Rating Scale: Neurologic
NCT00600756 (31) [back to overview]To Evaluate the Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population Regarding Health Economics Outcomes by Evaluating the Functional Improvement Rate of the Modified Vocational Status Index/ Location Code Index: Stable State
NCT00600756 (31) [back to overview]Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Intent-to-Treat (ITT) Population
NCT00600756 (31) [back to overview]Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Per Protocol Population
NCT00600756 (31) [back to overview]Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Emotional Regulation at Month 12 in the ITT Population.
NCT00600756 (31) [back to overview]Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Mental Functioning at Month 12 in the ITT Population.
NCT00600756 (31) [back to overview]Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Physical Functioning at Month 12 in the ITT Population.
NCT00600756 (31) [back to overview]Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Self-control at Month 12 in the ITT Population.
NCT00600756 (31) [back to overview]Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Social Integration at Month 12 in the ITT Population.
NCT00600756 (31) [back to overview]Evaluation of Effect of Quetiapine XR Versus Risperidone on the Health-related Quality of Life of Patients With Schizophrenia by Evaluating the Change From Baseline in EQ-5D(Euro Quality of Life-5 Dimension) Index Score at Month 12 in the ITT Population.
NCT00600756 (31) [back to overview]Number of Participants Using Antidepressants at Month 12 in the ITT Population
NCT00600756 (31) [back to overview]Number of Subjects Who Had an Unscheduled Visits Due to Worsening of Schizophrenia, Dose Change, or Adverse Event at Month 12 in the ITT Population
NCT00600756 (31) [back to overview]Responder Rate at Month 6 in the Per Protocol Population Using the Subjective Well-being Under Neuroleptics Scale, Short Version (SWN-K) Total Score
NCT00600756 (31) [back to overview]The Compliance of Patients Taking Quetiapine XR Versus Risperidone at Month 12 by Evaluating the Number of Participants Who Returned Study Drug at Month 12 in the ITT Population
NCT00600756 (31) [back to overview]The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in CGI-SCH Overall Severity Score
NCT00600756 (31) [back to overview]The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in CGI-SCH Overall Severity Score (Improved).
NCT00600756 (31) [back to overview]The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in the Calgary Depression Scale for Schizophrenia (CDSS) Total Score
NCT00600756 (31) [back to overview]The Effect of Quetiapine XR Versus Risperidone by Evaluating the Relapse Rate at Month 12 in the ITT Population
NCT00600756 (31) [back to overview]The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Mean Number of Lost School/Work Days at Month 12 in the ITT Population
NCT00600756 (31) [back to overview]The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Number of Participants Using Other Psychotropic Medications at Month 12 in the ITT Population
NCT00600756 (31) [back to overview]The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Participants With at Least 1 Hospitalization Due to Psychiatric Disorders at Month 12 in the ITT Population
NCT00600756 (31) [back to overview]The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Time Between First Study Drug Intake and First Hospitalization for Patients With 1 Hospitalization in the ITT Population
NCT00600756 (31) [back to overview]The Remission Rate in Both the Quetiapine XR Group and the Risperidone Group at Month 12 in the ITT Population
NCT00600756 (31) [back to overview]The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Mean Change From Baseline to Month 12 in Prolactin Levels in the Safety Population
NCT00617396 (1) [back to overview]Adequate Relief in Pain Score During Treatment
NCT00619892 (2) [back to overview]Change in Scores in Measurements of Depressive Symptoms (Hamilton Depression Rating Scale, HAM-D), Generalized Anxiety Symptoms (Hamilton Anxiety Rating Scale, HAM-A) and the Sleep Quality Item of the Pittsburgh Sleep Quality Index (PSQI).
NCT00619892 (2) [back to overview]Change in Mean Total Panic Disorder Severity Scale (PDSS) Scores
NCT00631748 (2) [back to overview]Percentage of Participants Attaining Abstinence for Three Weeks
NCT00631748 (2) [back to overview]Timeline Followback Interview (TLFB)
NCT00640562 (11) [back to overview]Change From Baseline to Week 12 of PANSS Score
NCT00640562 (11) [back to overview]Change From Screening Visit to Week 12 of Prolactin Live
NCT00640562 (11) [back to overview]Concomitant Use of Antidepressive Drugs From Baseline to Week 12
NCT00640562 (11) [back to overview]Concomitant Use of Antidepressive Drugs From Baseline to Week 12
NCT00640562 (11) [back to overview]Change From Baseline to Week 12 of HAM-D Score
NCT00640562 (11) [back to overview]- Change From Baseline to Week 12 of Clinical Global Impression (CGI- Severity of Illness) Score
NCT00640562 (11) [back to overview]Body Mass Index (BMI) at Week 12
NCT00640562 (11) [back to overview]CGI- Global Improvement Mean Score at Week 12
NCT00640562 (11) [back to overview]Change From Baseline in the Simpson Angus Scale (SAS) Total Score to Week 12 as an Indication of Neurological Side Effects Section
NCT00640562 (11) [back to overview]Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score.
NCT00640562 (11) [back to overview]Change From Baseline to Week 12 of Drug Attitude Inventory 10 Item Scale (DAI 10) Score
NCT00640601 (11) [back to overview]Change in Social and Occupational Functioning Assessment Scale (SOFAS)
NCT00640601 (11) [back to overview]Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Negative Scale Score
NCT00640601 (11) [back to overview]Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Positive Scale Score
NCT00640601 (11) [back to overview]Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score
NCT00640601 (11) [back to overview]Change in Clinical Global Impression-Improvement (CGI-I) Scale
NCT00640601 (11) [back to overview]Percentage of Subjects With Improved Clinical Benefit From Assessment of Clinical Global Impression-Clinical Benefit (CGI-CB) Scale From Baseline to Week 24 or End of Study
NCT00640601 (11) [back to overview]Change in Barnes Akathisia Rating Scale (BARS)
NCT00640601 (11) [back to overview]Change in Safety Measure: Simpson-Angus Scale (SAS)
NCT00640601 (11) [back to overview]Change in Global Assessment Scale (GAS)
NCT00640601 (11) [back to overview]Change in Clinical Global Impression-Severity (CGI-S) Scale
NCT00640601 (11) [back to overview]Change in Clinical Global Impression-Clinical Benefit (CGI-CB) Score
NCT00642369 (2) [back to overview]Percentage of Slow Wave Sleep
NCT00642369 (2) [back to overview]Percentage of Rapid Eye Movement Sleep
NCT00671853 (6) [back to overview]Change in Clinical Global Impressions of Improvement or Severity (CGI-I or S) Score
NCT00671853 (6) [back to overview]Change in Hamilton Rating Scale for Anxiety (HAM-A)
NCT00671853 (6) [back to overview]Change in the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score
NCT00671853 (6) [back to overview]Change in the 17 Item Hamilton Rating Scale for Depression (HAM-D-17) Score
NCT00671853 (6) [back to overview]Response Rate (≥ 50% Improvement) on Hamilton Rating Scale for Depression (HAM-D-17)
NCT00671853 (6) [back to overview]Remission Rate (≤ 7) on Hamilton Rating Scale for Depression (HAM-D-17)
NCT00672490 (9) [back to overview]Change From Baseline in the Young Mania Rating Scale (YMRS) Item 4 Score to Each Assessment
NCT00672490 (9) [back to overview]Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 28)
NCT00672490 (9) [back to overview]Remission Rate (Number of Patients With Clinically Significant Remission)
NCT00672490 (9) [back to overview]Response Rate (Number of Patients With Clinically Response)
NCT00672490 (9) [back to overview]Change From Baseline in the Clinical Global Impressions for Bipolar Disorder Severity of Illness (CGI-BP-S) Score to Each Assessment (Day 28)
NCT00672490 (9) [back to overview]Treatment of Agitation (Change From Baseline in the PANSS Activation Subscale Score to Day 28)
NCT00672490 (9) [back to overview]Treatment of Aggression Risk (Change From Baseline in the PANSS Supplement Aggression Risk Subscale Score to Day 28)
NCT00672490 (9) [back to overview]Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to Each Assessment(Day 28)
NCT00672490 (9) [back to overview]Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score to Each Assessment (Day 28)
NCT00674765 (1) [back to overview]TimeLine Follow Back (TLFB) to Measure Percent Heavy Drinking Days During the Medication/Placebo Phase
NCT00681668 (1) [back to overview]The Change in the Hamilton Rating Scale for Depression (HAM-D)
NCT00743366 (1) [back to overview]Measure of Relapse: Change in Puffs Chosen Between Baseline and Relapse Phase
NCT00746421 (2) [back to overview]Brief Assessment of Cognition for Affective Disorders (BAC-A)
NCT00746421 (2) [back to overview]The Continuous Performance Test-Identical Pairs Version
NCT00779506 (7) [back to overview]The Change in Positive and Negative Syndrome Scale(PANSS)Total Score
NCT00779506 (7) [back to overview]Positive and Negative Syndrome Scale (PANSS) Positive Score
NCT00779506 (7) [back to overview]Positive and Negative Syndrome Scale (PANSS) Negative Score
NCT00779506 (7) [back to overview]Positive and Negative Syndrome Scale (PANSS) General Psychopathology Score
NCT00779506 (7) [back to overview]Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
NCT00779506 (7) [back to overview]Global Assessment of Functioning (GAF) Score
NCT00779506 (7) [back to overview]Clinical Global Impression (CGI) Score
NCT00789698 (4) [back to overview]Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Positive and Negative Syndrome Scale (PANSS)
NCT00789698 (4) [back to overview]Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores.
NCT00789698 (4) [back to overview]Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Clinical Global Impression Severity Scale (CGI-S) Scores
NCT00789698 (4) [back to overview]Relapse of Psychotic Symptoms
NCT00789854 (30) [back to overview]Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, All Patients
NCT00789854 (30) [back to overview]Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With One Previous Treatment Failure
NCT00789854 (30) [back to overview]Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With Two Previous Treatment Failure
NCT00789854 (30) [back to overview]Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, All Patients
NCT00789854 (30) [back to overview]Change in Anxiety Measured by STAI, Trait Anxiety Inventory
NCT00789854 (30) [back to overview]Change in Anxiety Measured by State-Trait Anxiety Inventory (STAI), State Anxiety Inventory
NCT00789854 (30) [back to overview]Change in Anxiety Measured by Visual Analog Scale (VAS)
NCT00789854 (30) [back to overview]Change in Beck Depression Inventory (BDI)
NCT00789854 (30) [back to overview]Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With One Previous Treatment Failure
NCT00789854 (30) [back to overview]Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With Two Previous Treatment Failures
NCT00789854 (30) [back to overview]Change in Clinical Global Impression Scale (CGI-S), All Patients
NCT00789854 (30) [back to overview]Change in Clinical Global Impression Scale (CGI-S), Patients With One Previous Treatment Failure
NCT00789854 (30) [back to overview]Change in Clinical Global Impression Scale (CGI-S), Patients With Two Previous Treatment Failure
NCT00789854 (30) [back to overview]Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Modified Intention to Treat Analysis Set)
NCT00789854 (30) [back to overview]Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Per Protocol Analysis Set)
NCT00789854 (30) [back to overview]Change in Pain, Measured by Visual Analog Scale (VAS)
NCT00789854 (30) [back to overview]Change in Quality of Life Measured by Health Questionnaire EQ-5D as Utility
NCT00789854 (30) [back to overview]Change in Quality of Life Measured by Short-form Health Survey (SF-36), Mental Component
NCT00789854 (30) [back to overview]Change in Quality of Life Measured by Short-form Health Survey (SF-36), Physical Component
NCT00789854 (30) [back to overview]Change in Sleep Quality Measured by Montgomery Asberg Depression Rating Scale (MADRS), Item 4
NCT00789854 (30) [back to overview]Change in Sleep Quality Measured by Pittsburgh Sleep Quality Index (PSQI)
NCT00789854 (30) [back to overview]Change in Work Productivity and Activity Impairment: General Health (WPAI:GH)
NCT00789854 (30) [back to overview]Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With One Previous Treatment Failure
NCT00789854 (30) [back to overview]Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With Two Previous Treatment Failure
NCT00789854 (30) [back to overview]Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤12
NCT00789854 (30) [back to overview]Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤8
NCT00789854 (30) [back to overview]Depression Remission; Montgomery-Asberg Depression Rating Scale MADRS ≤10, All Patients
NCT00789854 (30) [back to overview]Responder: Clinical Global Impression Improvement (CGI-I) Item 2, All Patients
NCT00789854 (30) [back to overview]Responder: Clinical Global Impression Improvement (CGI-I) Item 2, Patients With Two Previous Treatment Failure
NCT00789854 (30) [back to overview]Responder: Clinical Global Impression Improvement (CGI)-I Item 2, Patients With One Previous Treatment Failure
NCT00790192 (2) [back to overview]Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment
NCT00790192 (2) [back to overview]Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase
NCT00806234 (4) [back to overview]Triglyceride Levels
NCT00806234 (4) [back to overview]Body Mass Index (BMI) Z-score Change
NCT00806234 (4) [back to overview]Change in Low Density Lipoprotein (LDL) Cholesterol Level
NCT00806234 (4) [back to overview]Change in Whole Body Insulin Sensitivity Index
NCT00811473 (6) [back to overview]The Number of Patients With the Response, Where Response is Defined as ≥50% Reduction From Baseline to Final Assessment (Day 57) in CDRS-R Total Score
NCT00811473 (6) [back to overview]The Proportion of Patients at Final Assessment (Day 57) With Improvement of Overall Bipolar Illness
NCT00811473 (6) [back to overview]Change From Baseline to Final Assessment (Day 57) in the CGI-BP-S
NCT00811473 (6) [back to overview]Number of Patients Reaching Remission Where Remission is Defined as CDRS-R Total Score ≤28 at Final Assessment (Day 57).
NCT00811473 (6) [back to overview]Change in the Children Depression Rating Scale, Revised (CDRS-R) Total Score From Baseline to Final Assessment (Day 57)
NCT00811473 (6) [back to overview]CGI-BP-C Score at Final Assessment (Day 57)
NCT00852631 (3) [back to overview]Clinical Global Impression - Severity of Illness (CGI-S) Score
NCT00852631 (3) [back to overview]Change in Clinical Global Impression - Severity of Illness (CGI-S) Score
NCT00852631 (3) [back to overview]Change in Positive and Negative Syndrome Scale (PANSS) Total Score
NCT00857584 (18) [back to overview]The Mean Change From Baseline to Week 8 in the Hamilton Anxiety Rating Scale (HARS) Total Score
NCT00857584 (18) [back to overview]The Mean Change From Baseline to Week 8 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
NCT00857584 (18) [back to overview]Number of Patients Response at Week 1
NCT00857584 (18) [back to overview]Number of Patients With Remission at Week 1.
NCT00857584 (18) [back to overview]Number of Patients With Remission at Week 2.
NCT00857584 (18) [back to overview]Number of Patients With Remission at Week 4.
NCT00857584 (18) [back to overview]Number of Patients With Remission at Week 8.
NCT00857584 (18) [back to overview]Number of Patients With Response at Week 2
NCT00857584 (18) [back to overview]Number of Patients With Response at Week 4.
NCT00857584 (18) [back to overview]Number of Patients With Response at Week 8.
NCT00857584 (18) [back to overview]The Mean Change From Baseline to Week 1 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score
NCT00857584 (18) [back to overview]The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
NCT00857584 (18) [back to overview]The Mean Change From Baseline to Week 1 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
NCT00857584 (18) [back to overview]The Mean Change From Baseline to Week 2 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score
NCT00857584 (18) [back to overview]The Mean Change From Baseline to Week 4 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score
NCT00857584 (18) [back to overview]The Mean Change From Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HARS) Total Score
NCT00857584 (18) [back to overview]The Mean Change From Baseline to Week 4 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
NCT00857584 (18) [back to overview]The Mean Change From Baseline to Week 8 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score
NCT00857818 (3) [back to overview]Mean Baseline Fasting Non-HDL Levels
NCT00857818 (3) [back to overview]Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Levels
NCT00857818 (3) [back to overview]Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and 1 or More AEs
NCT00868374 (1) [back to overview]Change in 17 Item Hamilton Rating Scale for Depression (HAM-D-17)
NCT00880919 (9) [back to overview]Global Assessment of Functioning Scale (GAF)
NCT00880919 (9) [back to overview]Montgomery-Åsberg Depression Rating Scale (MADRS)
NCT00880919 (9) [back to overview]Sheehan Disability Scale (SDS)
NCT00880919 (9) [back to overview]Symptom Checklist -90-Revised (SCL-90-R)
NCT00880919 (9) [back to overview]Young Mania Rating Scale (YMS)
NCT00880919 (9) [back to overview]Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD)
NCT00880919 (9) [back to overview]Overt Aggression Scale - Modified (OAS-M)
NCT00880919 (9) [back to overview]Barratt Impulsiveness Scale (BIS)
NCT00880919 (9) [back to overview]Borderline Evaluation of Severity Over Time (BEST)
NCT00882518 (9) [back to overview]Change From Baseline in PANSS Aggression, Hostility Clusters Score at the End of Treatment at Day 42
NCT00882518 (9) [back to overview]Change From Baseline in PANSS Depression Clusters Score at the End of Treatment at Day 42
NCT00882518 (9) [back to overview]Percentage of Patients With Clinical Global Impression (CGI) Global Improvement Rating Less Than or Equal to 3 at the End of Treatment at Day 42
NCT00882518 (9) [back to overview]Number of Patients Achieving a Reduction of at Least 30% From Baseline PANSS Total Score at the End of Treatment at Day 42
NCT00882518 (9) [back to overview]Change in the CGI Severity of Illness Score From Baseline at the End of Treatment at Day 42
NCT00882518 (9) [back to overview]Change From Baseline of the Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment at Day 42
NCT00882518 (9) [back to overview]Change From Baseline in PANSS Positive Subscale Score at the End of Treatment at Day 42
NCT00882518 (9) [back to overview]Change From Baseline in PANSS General Psychopathological Subscale Score at the End of Treatment at Day 42
NCT00882518 (9) [back to overview]Change From Baseline in PANSS Negative Subscale Score at the End of Treatment at Day 42
NCT00883493 (10) [back to overview]Change in Young Mania Rating Scale (YMRS) Total Score.
NCT00883493 (10) [back to overview]Change in the Pittsburgh Sleep Quality Index (PSQI)Total Score.
NCT00883493 (10) [back to overview]Change in the Clinical Global Impression Severity (CGI-S) Score.
NCT00883493 (10) [back to overview]Response Rate for MADRS.
NCT00883493 (10) [back to overview]Treatment Satisfaction Questionnaire (TSQ) Scores.
NCT00883493 (10) [back to overview]Change in Hamilton Rating Scale for Anxiety (HAM-A) Total Score
NCT00883493 (10) [back to overview]Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
NCT00883493 (10) [back to overview]Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Score.
NCT00883493 (10) [back to overview]Hamilton Rating Scale for Depression (HAM-D) Total Score.
NCT00883493 (10) [back to overview]Change in the Sheehan Disability Scale (SDS) Total Score.
NCT00926393 (13) [back to overview]Area Under the Modified Bond-Lader Visual Analog Scale-time Curve
NCT00926393 (13) [back to overview]Change in Abnormal Involuntary Movement Scale (AIMS) Total Score
NCT00926393 (13) [back to overview]Change in Barnes Akathisia Rating Scale (BARS) Global Score
NCT00926393 (13) [back to overview]Change in Simpson-Angus Scale (SAS) Total Score
NCT00926393 (13) [back to overview]Maximum Intensity Modified Bond-Lader Visual Analog Scale Score
NCT00926393 (13) [back to overview]Modified Bond-Lader Visual Analog Scale Score After 100-mg Dose (Day 3)
NCT00926393 (13) [back to overview]Modified Bond-Lader Visual Analog Scale Score After 200-mg Dose (Day 4)
NCT00926393 (13) [back to overview]Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 5)
NCT00926393 (13) [back to overview]Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 6)
NCT00926393 (13) [back to overview]Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2)
NCT00926393 (13) [back to overview]Number of Patients With Potential Extrapyramidal Symptoms (EPS)
NCT00926393 (13) [back to overview]Number of Patients With Potential Somnolence
NCT00926393 (13) [back to overview]Time to Maximum Intensity Modified Bond-Lader Visual Analog Scale Score
NCT00931723 (21) [back to overview]Change From Baseline to Day 43 in Each YMRS Item Score No. 9
NCT00931723 (21) [back to overview]Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
NCT00931723 (21) [back to overview]Change From Baseline to Day 43 in PANSS Activation Subscale Score
NCT00931723 (21) [back to overview]Change From Baseline to Day 43 in PANSS Positive Subscale Score
NCT00931723 (21) [back to overview]Change From Baseline to Day 43 in Positive and Negative Syndrome Scale (PANSS) Total Score
NCT00931723 (21) [back to overview]Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 43)
NCT00931723 (21) [back to overview]Improvement of Overall Bipolar Illness
NCT00931723 (21) [back to overview]Remission
NCT00931723 (21) [back to overview]The Number of Patients With Clinically Significant Response.
NCT00931723 (21) [back to overview]Change From Baseline to Day 43 in Each YMRS Item Score No. 5
NCT00931723 (21) [back to overview]Change From Baseline to Day 43 in CGI-BP-C (Clinical Global Impressions for Bipolar Disorder-Change From Preceding Phase)
NCT00931723 (21) [back to overview]Change From Baseline to Day 43 in CGI-BP-S (Clinical Global Impressions for Bipolar Disorder-Severity of Illness)
NCT00931723 (21) [back to overview]Change From Baseline to Day 43 in Each YMRS Item Score No. 1
NCT00931723 (21) [back to overview]Change From Baseline to Day 43 in Each YMRS Item Score No. 10
NCT00931723 (21) [back to overview]Change From Baseline to Day 43 in Each YMRS Item Score No. 11
NCT00931723 (21) [back to overview]Change From Baseline to Day 43 in Each YMRS Item Score No. 2
NCT00931723 (21) [back to overview]Change From Baseline to Day 43 in Each YMRS Item Score No. 3
NCT00931723 (21) [back to overview]Change From Baseline to Day 43 in Each YMRS Item Score No. 4
NCT00931723 (21) [back to overview]Change From Baseline to Day 43 in Each YMRS Item Score No. 6
NCT00931723 (21) [back to overview]Change From Baseline to Day 43 in Each YMRS Item Score No. 7
NCT00931723 (21) [back to overview]Change From Baseline to Day 43 in Each YMRS Item Score No. 8
NCT00951483 (7) [back to overview]Change in Hamilton Rating Scale for Anxiety (HAM-A)
NCT00951483 (7) [back to overview]Change in Hamilton Rating Scale for Depression With 21 Items (HAMD-21)
NCT00951483 (7) [back to overview]Change in Hamilton Rating Scale for Depression With Seven Items (HAM-D-7)
NCT00951483 (7) [back to overview]Change in Hamilton Rating Scale for Depression With 17 Items (HAM-D-17)
NCT00951483 (7) [back to overview]Change in Beck Depression Inventory (BDI)
NCT00951483 (7) [back to overview]Change in 14-item Perceived Stress Scale (PSS-14)
NCT00951483 (7) [back to overview]C-Reactive Protein at 12 Weeks
NCT00954122 (7) [back to overview]Change From Baseline to Final Visit at Day 21 in PANSS Negative, General Psychopathological Scores
NCT00954122 (7) [back to overview]Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S)
NCT00954122 (7) [back to overview]Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
NCT00954122 (7) [back to overview]Change From Baseline in Absolute Clinical Global Impression-Improvement (CGI-I) Scale
NCT00954122 (7) [back to overview]Change of the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score Compared From Baseline to Day 21.
NCT00954122 (7) [back to overview]Change From Baseline to Final Visit at Day 21 in PANSS Positive, General Psychopathological Scores.
NCT00954122 (7) [back to overview]Change From Baseline in Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score
NCT00954681 (1) [back to overview]Maximum Tolerated Dose of Quetiapine
NCT00955474 (15) [back to overview]RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Attention Sub-scale Scores at Baseline and Week 8.
NCT00955474 (15) [back to overview]Psychosis
NCT00955474 (15) [back to overview]LDL Blood Levels at Baseline and Week 8.
NCT00955474 (15) [back to overview]HDL Blood Levels at Baseline and Week 8.
NCT00955474 (15) [back to overview]Blood Level of Triglycerides at Baseline and Week 8.
NCT00955474 (15) [back to overview]RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Language Sub-scale Score.
NCT00955474 (15) [back to overview]Fasting Blood Glucose
NCT00955474 (15) [back to overview]Depression
NCT00955474 (15) [back to overview]CPFQ (Cognitive and Psychological Functioning Questionnaire)
NCT00955474 (15) [back to overview]Blood Level of Total Cholesterol Levels Were Collected at Baseline and Week 8.
NCT00955474 (15) [back to overview]Blood Hemoglobin A1C at Baseline and Week 8.
NCT00955474 (15) [back to overview]RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Immediate Memory Sub-scale Score
NCT00955474 (15) [back to overview]RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Total Score
NCT00955474 (15) [back to overview]RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Visuospatial/Constructional Sub-scale.
NCT00955474 (15) [back to overview]RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Delayed Memory Subscale Scores at Baseline and Week 8.
NCT00982345 (1) [back to overview]17-item Hamilton Depression Rating Scale (HDRS)
NCT01066143 (1) [back to overview]Change From Baseline in GAD Symptomatology at the Week 12 Timepoint.
NCT01066156 (1) [back to overview]Change From Baseline in PTSD Symptomatology at the Week 8 Timepoint.
NCT01133821 (2) [back to overview]Remission
NCT01133821 (2) [back to overview]Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)-Short Form
NCT01157351 (6) [back to overview]Time to First Psychiatric Hospitalization
NCT01157351 (6) [back to overview]Change From Baseline in Personal and Social Performance (PSP) Total Score During Overall Treatment Duration
NCT01157351 (6) [back to overview]Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Overall Treatment Duration
NCT01157351 (6) [back to overview]Percentage of Participants in Each Event Category of First Treatment Failure
NCT01157351 (6) [back to overview]Time to First Psychiatric Hospitalization or Arrest/Incarceration
NCT01157351 (6) [back to overview]Time to First Treatment Failure
NCT01165541 (1) [back to overview]Number of Very Heavy Drinking Days Per Week
NCT01195363 (1) [back to overview]Number of Patients Whose Mood Improved According to MADRS and YMRS Scale Scores.
NCT01213836 (7) [back to overview]Mean Treatment Satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM)
NCT01213836 (7) [back to overview]Number of Dropouts.
NCT01213836 (7) [back to overview]Mean for Attentional Standardised Composite Score Based on Performance Scores From the CogState Test Battery Domains Detection (Speed of Processing)and Identification (Attention/Vigilance)
NCT01213836 (7) [back to overview]Mean Overall Sedation as Measured by the Modified Bond-Lader Visual Analogue Scale (VAS) When Administered According to Label
NCT01213836 (7) [back to overview]Mean Overall Sedation as Measured by the Stanford Sleepiness Scale When Administered According to Label
NCT01213836 (7) [back to overview]Mean Ratio of Morning Plasma Concentration of Quetiapine and Nor-quetiapine for Quetiapine IR and Quetiapine XR, at Steady-state Conditions in the End of Each Treatment Period 1 and 2.
NCT01213836 (7) [back to overview]Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving
NCT01244711 (1) [back to overview]Montgomery Asberg Depression Rating Scale (MADRS)
NCT01254721 (2) [back to overview]The Changes From Baseline in Young Mania Rating Scale (YMRS) Total Score to Day 29
NCT01254721 (2) [back to overview]The Change From Baseline up to Day 29 and Final Assessment in the Clinical Global Impression-Severity of Illness Scale (CGI-S)
NCT01256177 (9) [back to overview]"The Proportion of Patients at Week 8 With a Clinical Global Impression - Bipolar - Change (CGI-BP-C) of Much or Very Much Improved"
NCT01256177 (9) [back to overview]Incidence of Treatment-emergent Mania (AE of Mania or Hypomania, Defined as Young Mania Rating Scale [YMRS] Score ≥16 on 2 Consecutive Assessments or Final Assessment)
NCT01256177 (9) [back to overview]Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment)
NCT01256177 (9) [back to overview]Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Response (Subjects With ≥50% Reduction From Baseline to Week 8 in MADRS Total Score)
NCT01256177 (9) [back to overview]Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
NCT01256177 (9) [back to overview]Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar - Severity (CGI-BP-S)
NCT01256177 (9) [back to overview]Change From Baseline to Week 8 in HAM-D Total Scores
NCT01256177 (9) [back to overview]Change From Baseline to Week 8 in Item 10 of Montgomery-Asberg Depression Rating Scale (MADRS) for Suicidal Ideation
NCT01256177 (9) [back to overview]Change From Baseline to Each Assessment in MADRS Total Score
NCT01331304 (4) [back to overview]Necessary Clinical Adjustments
NCT01331304 (4) [back to overview]Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)
NCT01331304 (4) [back to overview]Clinical Global Impression-Efficacy Index (CGI-EI)
NCT01331304 (4) [back to overview]Risk of Cardiovascular Disease - Framingham Risk Score
NCT01526148 (2) [back to overview]Time to Study Discontinuation
NCT01526148 (2) [back to overview]Lithium vs. Quetiapine Effects on General Cardiovascular Disease Risk as Measured by Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
NCT01588457 (4) [back to overview]Demographic in Randomization 1 Group
NCT01588457 (4) [back to overview]Baseline Randomization Percentage of Bipolar Types
NCT01588457 (4) [back to overview]Bipolar Inventory of Symptoms Scale (BISS)
NCT01588457 (4) [back to overview]Global Assessment of Functioning
NCT01662297 (9) [back to overview]Change in Insomnia Severity Index (ISI) Scores
NCT01662297 (9) [back to overview]Change in RAND Short Form 36 Item Health Survey (RAND-SF36) General Health Subscale Over Time
NCT01662297 (9) [back to overview]Medical Outcomes Study Sleep Scale- Sleep Index (Short)
NCT01662297 (9) [back to overview]Percentage of Heavy Drinking Days
NCT01662297 (9) [back to overview]Percentage of Negative Urine Drug Screens
NCT01662297 (9) [back to overview]Change in Alcohol Urge Questionnaire (AUQ)Scores Over Time
NCT01662297 (9) [back to overview]Change in Average Pittsburgh Sleep Quality Inventory (PSQI)Score
NCT01662297 (9) [back to overview]Change in Brief Symptom Inventory (BSI) Over Time
NCT01662297 (9) [back to overview]Change in Epworth Sleepiness Scale (ESS) Over Time
NCT01697709 (2) [back to overview]Marijuana Use, Daily Dollar Averaged Over 7 Days During Each of 12 Weeks of Study
NCT01697709 (2) [back to overview]Number of Participants Stratified by Marijuana Abstinence Days Per Week
NCT01725282 (6) [back to overview]Change From Baseline in Pittsburgh Sleep Quality Index (PSQI)
NCT01725282 (6) [back to overview]Percentage of Participants With Improvement in Clinical Global Impressions-Improvement (CGI-I)
NCT01725282 (6) [back to overview]Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
NCT01725282 (6) [back to overview]Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests
NCT01725282 (6) [back to overview]Change From Baseline in Hamilton Rating Score for Depression (HAM-D17)
NCT01725282 (6) [back to overview]Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I)
NCT01725308 (74) [back to overview]Change From Baseline in YMRS (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Change From Baseline in YMRS (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Change From Baseline in MADRS Total Score (Treatment Period I)
NCT01725308 (74) [back to overview]Change From Baseline in MADRS Total Score (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Change From Baseline in MADRS Total Score (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I)
NCT01725308 (74) [back to overview]Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I)
NCT01725308 (74) [back to overview]Change From Baseline in HAM-D17 (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Change From Baseline in HAM-D17 (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Change From Baseline in Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS): Total Score (Treatment Period I)
NCT01725308 (74) [back to overview]Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Change From Baseline in DIEPSS: Parkinsonism (Treatment Period I)
NCT01725308 (74) [back to overview]Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II
NCT01725308 (74) [back to overview]Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I)
NCT01725308 (74) [back to overview]Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With MADRS Response (Treatment Period I)
NCT01725308 (74) [back to overview]Number of Participants With MADRS Response (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With MADRS Response (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With MADRS Remission (Treatment Period I)
NCT01725308 (74) [back to overview]Number of Participants With MADRS Remission (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With MADRS Remission (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With HAM-D17 Response (Treatment Period I)
NCT01725308 (74) [back to overview]Number of Participants With HAM-D17 Response (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With HAM-D17 Response (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Change From Baseline to End of Treatment Period I in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
NCT01725308 (74) [back to overview]Change From Baseline in CGI-BP-S: Depression (Treatment Period I)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]CGI-BP-C: Mania (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]CGI-BP-C: Mania (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]CGI-BP-C: Depression (Treatment Period I)
NCT01725308 (74) [back to overview]CGI-BP-C: Depression (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]CGI-BP-C: Depression (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II
NCT01725308 (74) [back to overview]CGI-BP-C: Overall Bipolar Illness (Treatment Period I)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II)
NCT01725308 (74) [back to overview]Number of Participants With Adverse Events (Treatment Period I)
NCT01725308 (74) [back to overview]Number of Participants With Adverse Events (Combined Treatment Period I and II)
NCT01727726 (9) [back to overview]CGI-I Response Rate
NCT01727726 (9) [back to overview]MADRS Response at Week 6
NCT01727726 (9) [back to overview]Montgomery Asberg Depression Rating Scale (MADRS)
NCT01727726 (9) [back to overview]Number of Participants With MADRS
NCT01727726 (9) [back to overview]Sheehan Disability Scale (SDS)
NCT01727726 (9) [back to overview]Change From End of Phase A in MADRS Total Score for Trial Week 2 and Week 4.
NCT01727726 (9) [back to overview]Clinical Global Impression Score
NCT01727726 (9) [back to overview]Number of Participants With Adverse Events
NCT01727726 (9) [back to overview]Sheehan Disability Scale (SDS) Individual Item Scores.
NCT01737268 (9) [back to overview]Change From Baseline to Last Assessment in Treatment Period in Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness
NCT01737268 (9) [back to overview]Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Mania
NCT01737268 (9) [back to overview]Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Depression
NCT01737268 (9) [back to overview]CGI-BP-C: Mania
NCT01737268 (9) [back to overview]CGI-BP-C: Depression
NCT01737268 (9) [back to overview]Change From Baseline to Last Assessment in Treatment Period in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
NCT01737268 (9) [back to overview]Number of Participants With Adverse Events
NCT01737268 (9) [back to overview]Clinical Global Impression-Bipolar-Change (CGI-BP-C): Overall Bipolar Illness
NCT01737268 (9) [back to overview]Change From Baseline to Last Assessment in Treatment Period in Hamilton Depression Scale (HAM-D17)
NCT01810380 (18) [back to overview]Change From Baseline to Week 6 in PANSS Positive Subscale Score
NCT01810380 (18) [back to overview]Change From Baseline to Week 6 in PANSS Negative Subscale Score
NCT01810380 (18) [back to overview]Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility/Excitement
NCT01810380 (18) [back to overview]Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms
NCT01810380 (18) [back to overview]Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms
NCT01810380 (18) [back to overview]Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thoughts
NCT01810380 (18) [back to overview]Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety/Depression
NCT01810380 (18) [back to overview]Change From Baseline to Week 6 in PANSS General Psychopathology Subscale Score
NCT01810380 (18) [back to overview]Change From Baseline to Week 6 in CGI-S Score
NCT01810380 (18) [back to overview]CGI-I Score at Week 6
NCT01810380 (18) [back to overview]Discontinuation Due to Lack of Efficacy During the Study
NCT01810380 (18) [back to overview]PSP Functional Remission Rate at Week 6
NCT01810380 (18) [back to overview]PSP Functional Response Rate at Week 6
NCT01810380 (18) [back to overview]Response Rate at Week 6
NCT01810380 (18) [back to overview]Change From Baseline to Week 6 in PANSS Excited Component Score
NCT01810380 (18) [back to overview]Change From Baseline to Week 6 in PANSS Total Score
NCT01810380 (18) [back to overview]PSP Domain D: Disturbing and Aggressive Behaviours at Week 6
NCT01810380 (18) [back to overview]Change From Baseline to Week 6 in PSP Total Score
NCT01833897 (5) [back to overview]Loss of Motivated Behavior HAM-D Factor
NCT01833897 (5) [back to overview]Beck's Depression Inventory
NCT01833897 (5) [back to overview]HAM-D Suicide Item
NCT01833897 (5) [back to overview]Hamilton Anxiety Scale
NCT01833897 (5) [back to overview]Hamilton Depression Rating Scale (HAM-D)
NCT01844700 (4) [back to overview]Weight Change
NCT01844700 (4) [back to overview]BMI Percentile
NCT01844700 (4) [back to overview]BMI Z-scores
NCT01844700 (4) [back to overview]Percent Weight Change Compared to Baseline Weight
NCT01858948 (3) [back to overview]Body Mass Index (BMI)
NCT01858948 (3) [back to overview]Fasting Blood Triglycerides Levels
NCT01858948 (3) [back to overview]Manic Symptom Severity
NCT01971203 (4) [back to overview]Changes in Sexual Functioning Questionnaire (CSFQ)
NCT01971203 (4) [back to overview]Clinical Global Impression Scales for Severity and Improvement
NCT01971203 (4) [back to overview]HAM-A
NCT01971203 (4) [back to overview]MADRS
NCT02056171 (3) [back to overview]Change in Delirium Severity
NCT02056171 (3) [back to overview]Time to First Resolution of Delirium
NCT02056171 (3) [back to overview]Total ICU Days With Delirium
NCT02362412 (9) [back to overview]Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
NCT02362412 (9) [back to overview]Clinical Global Impression-Bipolar-Change (CGI-BP-C):Mania
NCT02362412 (9) [back to overview]Clinical Global Impression-Bipolar-Change (CGI-BP-C):Depression
NCT02362412 (9) [back to overview]Number of Participants With Adverse Events
NCT02362412 (9) [back to overview]Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Mania
NCT02362412 (9) [back to overview]Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S):Depression
NCT02362412 (9) [back to overview]Hamilton Depression Scale (HAM-D17)
NCT02362412 (9) [back to overview]Clinical Global Impression-Bipolar-Change (CGI-BP-C):Overall Bipolar Illness
NCT02362412 (9) [back to overview]Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness
NCT02431702 (31) [back to overview]Part 3 (EDP): Change From Baseline in Reasoning and Problem Solving: MCCB Domain
NCT02431702 (31) [back to overview]Part 3 (EDP): Change From Baseline in Medication Satisfaction Questionnaire (MSQ) Score
NCT02431702 (31) [back to overview]Part 3 (EDP): Change From Baseline in Functioning as Measured by the Personal and Social Performance (PSP) Total Score
NCT02431702 (31) [back to overview]Part 3 (EDP): Change From Baseline in Clinical Global Impression Severity (CGI-S) Score
NCT02431702 (31) [back to overview]Part 3 (EDP): Change From Baseline in Attention/Vigilance Score: MCCB Domain
NCT02431702 (31) [back to overview]Part 3 (EDP): Change From Baseline in Adjusted Intracortical Myelin Fraction Score as Measured by Inversion Recovery (IR) and Spin Echo Magnetic Resonance Imaging (MRI)
NCT02431702 (31) [back to overview]Part 3 (Disease Modification): Personal and Social Performance (PSP) Total Observed Score
NCT02431702 (31) [back to overview]Part 3 (Disease Modification): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score
NCT02431702 (31) [back to overview]Part 2 (Disease Progression): Change From Baseline in Working Memory Score: MCCB Domain
NCT02431702 (31) [back to overview]Part 2 (Disease Progression): Change From Baseline in Visual Learning Score: MCCB Domain
NCT02431702 (31) [back to overview]Part 2 (Disease Progression): Change From Baseline in Speed of Processing Score: MCCB Domain
NCT02431702 (31) [back to overview]Part 2 (Disease Progression): Change From Baseline in Social Cognition Score: MCCB Domain
NCT02431702 (31) [back to overview]Part 2 (Disease Progression): Change From Baseline in Reasoning and Problem Solving: MCCB Domain
NCT02431702 (31) [back to overview]Part 2 (Disease Progression): Change From Baseline in Medication Satisfaction Questionnaire (MSQ) Total Score
NCT02431702 (31) [back to overview]Part 2 (Disease Progression): Change From Baseline in Functioning as Measured by the Personal and Social Performance (PSP) Total Score
NCT02431702 (31) [back to overview]Part 2 (Disease Progression): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score
NCT02431702 (31) [back to overview]Part 2 (Disease Progression): Change From Baseline in Clinical Global Impression Severity (CGI-S) Score
NCT02431702 (31) [back to overview]Part 2 (Disease Progression): Change From Baseline in Attention/Vigilance Score: MCCB Domain
NCT02431702 (31) [back to overview]Part 2 (Disease Progression): Change From Baseline in Adjusted Intracortical Myelin (ICM) Fraction Score as Measured by Inversion Recovery (IR) and Spin Echo Magnetic Resonance Imaging (MRI)
NCT02431702 (31) [back to overview]Part 3 (EDP): Time to First Treatment Failure
NCT02431702 (31) [back to overview]Part 3 (EDP): Number of Participants With Change From Baseline in Severity of Psychotic Symptoms, as Measured by CRDPSS
NCT02431702 (31) [back to overview]Part 2 (Disease Progression): Number of Participants With Change From Baseline in Severity of Psychotic Symptoms, as Measured by Clinician-Rated Dimensions of Psychosis Symptom Severity Scale (CRDPSS)
NCT02431702 (31) [back to overview]Part-2 (Disease Progression): Time to First Treatment Failure
NCT02431702 (31) [back to overview]Part 3 (Extended Disease Progression [EDP]): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score
NCT02431702 (31) [back to overview]Part 2 (Disease Progression): Change From Baseline in Verbal Learning Score: MCCB Domain
NCT02431702 (31) [back to overview]Part 3 (EDP): Change From Baseline in Working Memory Score: MCCB Domain
NCT02431702 (31) [back to overview]Part 3 (EDP): Change From Baseline in Visual Learning Score: MCCB Domain
NCT02431702 (31) [back to overview]Part 3 (EDP): Change From Baseline in Verbal Learning Score: MCCB Domain
NCT02431702 (31) [back to overview]Part 3 (EDP): Change From Baseline in Speed of Processing Score: MCCB Domain
NCT02431702 (31) [back to overview]Part 3 (EDP): Change From Baseline in Social Cognition Score: MCCB Domain
NCT02431702 (31) [back to overview]Part 3 (Disease Modification): Change From Baseline in Adjusted Intracortical Myelin Fraction Score as Measured by Inversion Recovery (IR) and Spin Echo Magnetic Resonance Imaging (SE MRI)
NCT02462473 (8) [back to overview]Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12
NCT02462473 (8) [back to overview]Number of Participants With Medication Treatment Modifications (MTM)
NCT02462473 (8) [back to overview]Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12
NCT02462473 (8) [back to overview]Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12
NCT02462473 (8) [back to overview]Number of Participants With Factors Considered in Clinical Decision as Assessed by Clinical Assessment of the Schizophrenia Patient (CASP)
NCT02462473 (8) [back to overview]Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12
NCT02462473 (8) [back to overview]Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12
NCT02462473 (8) [back to overview]Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12
NCT02720198 (11) [back to overview]Changes of Quality of Life in Scores on Sheehan Disability Scale (SDS) Total
NCT02720198 (11) [back to overview]Number of Subjects With General Improvement in Scores on Clinical Global Impression Scale- Improvement (CGI-I)
NCT02720198 (11) [back to overview]Number of Subjects With Global Improvement in Scores on Clinical Global Impression Scale- Severity (CGI-S)
NCT02720198 (11) [back to overview]Remission Rate
NCT02720198 (11) [back to overview]Response Rate
NCT02720198 (11) [back to overview]Changes in Neurocognition by Changes in Scores on Reyes Verbal Learning Test
NCT02720198 (11) [back to overview]Changes in Neurocognition by Changes in Scores on Scores on Digit Symbol Substitution Test (DSST)
NCT02720198 (11) [back to overview]Changes in Scores on Apathy Evaluation Scale (AES).
NCT02720198 (11) [back to overview]Changes in Sexual Dysfunction by Changes in Scores on Arizona Sexual Experience Scale (ASEX)
NCT02720198 (11) [back to overview]Changes of Anxiety Symptoms in Scores on Hamilton Anxiety Rating Scale (HAM-A)
NCT02720198 (11) [back to overview]Changes of Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score
NCT02845453 (5) [back to overview]Change in Timeline Followback of Substance Use (TLFB)
NCT02845453 (5) [back to overview]Change in the Number of Negative Urine Toxicology Specimens
NCT02845453 (5) [back to overview]Change in Symptoms of Mania
NCT02845453 (5) [back to overview]Change in Symptoms of Depression
NCT02845453 (5) [back to overview]Change in Craving for the Substance That the Participant Identifies as Most Problematic
NCT03019887 (1) [back to overview]Number of Participants With Relapse
NCT03207438 (4) [back to overview]MADRS Response Rates
NCT03207438 (4) [back to overview]Number of Participants With 50 Percent Or Greater Reduction in the MADRS Score Over Time for the Quetiapine XR 150-300mg and Placebo 2 Arms/Groups Stratified by Depression Type (Melancholic vs. Nonmelancholic)
NCT03207438 (4) [back to overview]Modified MADRS Response Rates
NCT03207438 (4) [back to overview]Modified MADRS Response Rate
NCT03321526 (38) [back to overview]Percentage of Participants With Suicidality Assessed Using Columbia Suicide Severity Rating Scale (C-SSRS) Score
NCT03321526 (38) [back to overview]Percentage of Participants With Shifts in Triglycerides From High to Very High
NCT03321526 (38) [back to overview]Percentage of Participants With Shifts in Triglycerides From Borderline to Very High
NCT03321526 (38) [back to overview]Percentage of Participants With Shifts in Triglycerides From Borderline to High
NCT03321526 (38) [back to overview]Percentage of Participants With Shifts in Fasting Blood Glucose From Normal to Borderline
NCT03321526 (38) [back to overview]Percentage of Participants With Sexual Dysfunction as Determined by Arizona Sexual Experiences Scale (ASEX) Total Score
NCT03321526 (38) [back to overview]Percentage of Participants With Clinically Relevant Changes in Extrapyramidal Symptoms Assessed by the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Score
NCT03321526 (38) [back to overview]Percentage of Participants With Abnormalities in Electrocardiogram (ECG) Parameters
NCT03321526 (38) [back to overview]Percentage of Participants With Abnormalities in Clinical Laboratory Parameters
NCT03321526 (38) [back to overview]Percentage of Participants With Shifts in Fasting Blood Glucose From Borderline to High
NCT03321526 (38) [back to overview]Percentage of Participants With Shifts in Triglycerides From Normal to Very High
NCT03321526 (38) [back to overview]Percentage of Participants With Sustained Remission up to Week 24
NCT03321526 (38) [back to overview]Percentage of Participants With Sustained Response up to Week 24
NCT03321526 (38) [back to overview]Percentage of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability
NCT03321526 (38) [back to overview]Percentage of Participants With Weight Gain of >=7% of Baseline Body Weight at Week 24
NCT03321526 (38) [back to overview]Time to All-Cause Discontinuation of Study Drug
NCT03321526 (38) [back to overview]Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) at Weeks 6, 12, and 24
NCT03321526 (38) [back to overview]Change From Baseline in MADRS Total Score in Participants With Significant Insomnia (Baseline Insomnia Severity Index [ISI] Score >=15) Versus Those Without Significant Insomnia (Baseline ISI Score Less Than [<] 15) at Week 12
NCT03321526 (38) [back to overview]Change From Baseline in MADRS Total Score in Participants With Significant Insomnia (Baseline ISI Score >=15) Versus Those Without Significant Insomnia (Baseline ISI Score <15) at Week 18
NCT03321526 (38) [back to overview]Change From Baseline in MADRS Total Score in Participants With Significant Insomnia (Baseline ISIscore >=15) Versus Those Without Significant Insomnia (Baseline ISI Score 15) at Week 24
NCT03321526 (38) [back to overview]Change From Baseline in MADRS Total Score Over Time
NCT03321526 (38) [back to overview]Percentage of Participants With Abnormalities in Vital Sign Parameters
NCT03321526 (38) [back to overview]Percentage of Participants With Shifts in Fasting Blood Glucose From Normal to High
NCT03321526 (38) [back to overview]Change From Baseline in MADRS Total Score Over Time, by Mode Dose
NCT03321526 (38) [back to overview]Change From Baseline in MADRS-6 Score Over Time
NCT03321526 (38) [back to overview]Change From Baseline in Patient Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form 8a at Weeks 12 and 24
NCT03321526 (38) [back to overview]Change From Baseline in Patient Reported Outcomes Measurement Information System-Sleep Related Impairment (PROMIS-SRI) Short Form 8a at Weeks 12 and 24
NCT03321526 (38) [back to overview]Change From Baseline in Quality of Life in Depression Scale (QLDS) Score at Weeks 12 and 24
NCT03321526 (38) [back to overview]Change From Baseline in Salivary Cortisol Levels as Measured at Home Upon Awakening and During the Evening at Weeks 6 and 24
NCT03321526 (38) [back to overview]Change From Baseline in Symbol Digit Modalities Test (SDMT) at Weeks 6, 12, and 24
NCT03321526 (38) [back to overview]Change From Baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) Score at Weeks 12 and 24
NCT03321526 (38) [back to overview]Percentage of Participants With Shifts in Triglycerides From Normal to High
NCT03321526 (38) [back to overview]Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Scale Score at Weeks 12 and 24
NCT03321526 (38) [back to overview]Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A) Total Score at Weeks 12, 18, and 24
NCT03321526 (38) [back to overview]Change From Baseline in the Patient Global Impression Severity (PGI-S) Scale Score at Weeks 12 and 24
NCT03321526 (38) [back to overview]Change From Baseline in Trail Making Test - Part B (TMT-Part B) at Weeks 6, 12, and 24
NCT03321526 (38) [back to overview]Percentage of Participant With Potential Withdrawal Effects Assessed by the Physician Withdrawal Checklist (PWC)
NCT03321526 (38) [back to overview]Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) and Events of Special Interest
NCT03557931 (8) [back to overview]Number of Participants With Clinically Significant Differences in Simpson Angus Scale (SAS) Values
NCT03557931 (8) [back to overview]Number of Participants With Clinically Significant Differences in Barnes Akathisia Rating Scale (BARS) Values
NCT03557931 (8) [back to overview]Change From Baseline to Week 12/End of Treatment (EoT) in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score
NCT03557931 (8) [back to overview]Number of Participants With Clinically Significant Differences in Columbia-Suicide Severity Rating Scale (C-SSRS) Values
NCT03557931 (8) [back to overview]Number of Participants With Clinically Significant Differences in Abnormal Involuntary Movement Scale (AIMS) Values
NCT03557931 (8) [back to overview]Number of Participants With Adverse Event (AE)
NCT03557931 (8) [back to overview]Concentration at Trough Level (Ctrough) for ASP4345
NCT03557931 (8) [back to overview]Change From Baseline to Week 12/EoT in University of California San Diego Performance-based Skills Assessment-2 Extended Range (UPSA-2-ER) Total Score
NCT03568500 (2) [back to overview]Percentage Of Days With Good Patch Coverage
NCT03568500 (2) [back to overview]Participant Adherence
NCT04164758 (1) [back to overview]Treatment-emergent Adverse Events (TEAEs)
NCT04338321 (25) [back to overview]Change From Baseline in Participant-reported Health-related Quality of Life (HRQoL) and Health Status as Assessed by 36-item Short-Form Health Survey (SF-36) Scale Score
NCT04338321 (25) [back to overview]Change From Baseline in Participant-reported Health-related Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) Score: Health Status Index
NCT04338321 (25) [back to overview]Change From Baseline in Participant-reported Health-related Quality of Life Group, as Assessed by EQ-5D-5L Score: Health Status Index at LOCF
NCT04338321 (25) [back to overview]Change From Baseline in Participant-reported HRQoL and Health Status as Assessed by SF-36 Scale Score at LOCF
NCT04338321 (25) [back to overview]Change From Baseline in Participant-reported Quality of Life as Assessed by QLDS Total Score at LOCF
NCT04338321 (25) [back to overview]Change From Baseline in Participant-reported Quality of Life as Assessed by Quality of Life in Depression Scale (QLDS) Total Score
NCT04338321 (25) [back to overview]Change From Baseline in Participant-reported Work Productivity as Assessed by WPAI: Depression Questionnaire at LOCF
NCT04338321 (25) [back to overview]Clinician-rated Overall Severity of Depressive Illness as Assessed by Clinical Global Impression - Change (CGI-C) Scale Score
NCT04338321 (25) [back to overview]Number of Participants With Clinician-rated Overall Severity of Depressive Illness as Assessed by CGI-C Scale Score at LOCF
NCT04338321 (25) [back to overview]Change From Baseline in Clinician-rated Overall MADRS Score at Last Observation Carried Forward (LOCF)
NCT04338321 (25) [back to overview]Change From Baseline in Clinician-rated Overall MADRS Score
NCT04338321 (25) [back to overview]Change From Baseline in Participant-reported Depressive Symptoms as Assessed by PHQ 9-item Total Score at LOCF
NCT04338321 (25) [back to overview]Change From Baseline in Participant-reported Depressive Symptoms as Assessed by Patient Health Questionnaire (PHQ) 9-item Total Score
NCT04338321 (25) [back to overview]Number of Participants With TEAEs of Special Interest
NCT04338321 (25) [back to overview]Change From Baseline in Clinician-rated Overall Severity of Depressive Illness as Assessed by Clinical Global Impression - Severity (CGI-S) Scale Score
NCT04338321 (25) [back to overview]Change From Baseline in Participant-reported Functional Impairment and Associated Disability as Assessed by SDS Total Score at LOCF
NCT04338321 (25) [back to overview]Change From Baseline in Participant-reported Functional Impairment and Associated Disability as Assessed by Sheehan Disability Scale (SDS) Total Score
NCT04338321 (25) [back to overview]Change From Baseline in Participant-reported Health Status as Assessed by EQ-5D-5L Score: VAS
NCT04338321 (25) [back to overview]Change From Baseline in Participant-reported Work Productivity as Assessed by Work Productivity and Activity Impairment (WPAI): Depression Questionnaire
NCT04338321 (25) [back to overview]Change From Baseline in Participant-reported Health Status as Assessed by EQ-5D-5L Score: VAS at LOCF
NCT04338321 (25) [back to overview]Percentage of Participants With Remission as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) Score at Week 8
NCT04338321 (25) [back to overview]Percentage of Participants With Both Remission at Week 8 and Relapse-free Until Week 32
NCT04338321 (25) [back to overview]Change From Baseline in Clinician-rated Overall Severity of Depressive Illness as Assessed by CGI-S Scale Score at LOCF
NCT04338321 (25) [back to overview]Number of Participants With Treatment-emergent Adverse Events (TEAEs)
NCT04338321 (25) [back to overview]Number of Participants With Suicidal Ideation or Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score

Number Who Discontinued Medication Within First 6 Study Months

(NCT00044655)
Timeframe: Measured at Six Months

Interventionparticipants (Number)
Stay11
Switch23

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Remission (HAM-A ≤ 7)

Remission was measured as a secondary outcome using a score of less than or equal to 7 on the Hamilton Anxiety Scale (HAM-A). (NCT00113295)
Timeframe: Week 18 (Study Endpoint)

Interventionparticipants (Number)
Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine4
Placebo Augmentation of Continued Paroxetine2

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Response, Clinical Global Impression of Improvement (CGI-I)

"Response was measured as a secondary outcome using the Clinical Global Impression of Improvement (CGI-I). Response was defined as a score of 1 [very much improved] or 2 [much improved] at study endpoint." (NCT00113295)
Timeframe: Week 18 (Phase 2 Endpoint)

Interventionparticipants (Number)
Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine6
Placebo Augmentation of Continued Paroxetine5

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Depressive Symptoms, Montgomery-Asberg Depression Rating Scale (MADRS)

Depressive symptoms were measured at a secondary outcome using the Montgomery-Asberg Depression Rating Scale (MADRS). Each item is scored on a scale of 1-6; The total score range is 0-60, with higher scores indicated higher levels of depression severity. (NCT00113295)
Timeframe: Week 10 (Phase 1 Endpoint) and Week 18 (Phase 2 Endpoint)

,
Interventionunits on a scale (Mean)
Baseline (Week 10)Endpoint (Week 18)
Placebo Augmentation of Continued Paroxetine12.3611.64
Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine11.4510.27

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Hamilton Anxiety Scale (HAM-A) Score at Study Endpoint.

"Symptoms of generalized anxiety disorder as measured by the Hamilton Anxiety Scale (HAM-A) at week 18/study endpoint. Each item is scored on a scale from 0 (not present) to 4 (severe) with a total score range of 0-56. Changes in HAM-A scores are calculated as the difference between the baseline HAM-A scores and scores at week 18/study endpoint.~The 14-item Hamilton Anxiety Rating Scale (HAM-A) (Hamilton, 1959) was developed to assess anxiety in a clinical population. It is considered a measure of general anxiety across anxiety disorders, in addition to being a gold standard measure for GAD." (NCT00113295)
Timeframe: Baseline and Week 18

,
Interventionunits on a scale (Mean)
BaselineWeek 18Change
Placebo Augmentation of Continued Paroxetine15.8215.55-0.3
Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine16.2713.64-2.6

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The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q).

The 16-item Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is used to assess quality of life changes with treatment. Total scores range from 14-70, with higher levels of satisfaction yielding higher scores. (NCT00113295)
Timeframe: Week 10 (Phase 1 Endpoint) and Week 18 (Phase 2 Endpoint)

,
Interventionunits on a scale (Mean)
Baseline (Week 10)Endpoint (Week 18)
Placebo Augmentation of Continued Paroxetine45.8945.11
Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine45.1346.25

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Mean Number of Drinking Days Per Week

Timeline Follow-back (TLFB) procedure was used at screening and baseline to establish current substance use, and it was also used weekly during the course of the study to assess continued alcohol and other substance use. TLFB cosisted of using a calendar and sasking participants to report alcohol and other drug use since last visit. At the screening visit, the TLFB was done for the four weeks prior to the visit. (NCT00156715)
Timeframe: 12 Weeks

InterventionDrinking Days per Week (Mean)
QUET2.7

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Clinical Symptoms

The main outcome measure of clinical symptoms was the Positive and Negative Symptoms Scale. This is a 30 item scale for assessing patients diagnosed with schizophrenia. Each item is rated on a 1 (absent) to 7 (extreme) scale. The minimum total score is 30 and the maximum is 210. (NCT00156715)
Timeframe: 12 Weeks

InterventionUnits on a scale (Mean)
QUET65.5

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Evaluate the Number of Clinical Events (Pooled) Occurring Between 3-15 Months Following a Switch/Stabilization of the Antipsychotic Agents Among Patients Who Receive Either Risperidal Consta or One of the 4 Marketed 2nd Generation Antipsychotic Agents.

(NCT00177164)
Timeframe: Upto 15 months

InterventionNumber of clinical events (Mean)
Risperidone LAI0.86
Oral AAP1.61

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Number of Participants With Treatment Emergent Hyperlipidemia

Number of participants with Hyperlipidemia as determined by safety labs (NCT00177164)
Timeframe: from baseline to end of 15 months

Interventionparticipants (Number)
Risperidone LAI0
Oral AAP0

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Number of Participants With Treatment - Emergent Hyperglycemia

Number of participants with hyperglycemia based on safety labs (NCT00177164)
Timeframe: from baseline to end of 15 months

Interventionparticipants (Number)
Risperidone LAI0
Oral AAP0

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BMI

BMI at baseline and at end of 15 months for Risperidone LAI and oral AAP groups (NCT00177164)
Timeframe: baseline to end of 15 months

,
Interventionkg / m^2 (Mean)
BaselineFinal
Oral AAP29.8632.0
Risperidone LAI31.0532.27

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Change in Bipolar Symptoms as Measured by Reduction in Young-Mania Rating Scale (Y-MRS) Total Score

The Y-MRS is used to evaluate mania symptoms in children and adolescents. Items on the scale are rated from 0-4 or 0-8, with higher values indicating greater severity. The minimum (least severe) total score is 0, with the maximum (most severe) score is 60. (NCT00181883)
Timeframe: Baseline to 8 weeks

InterventionUnits on a scale (Mean)
Quetiapine-14.5

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Symptoms of Mania, as Measured by Young Mania Rating Scale

Symptoms of mania, as measured by Young Mania Rating Scale. The scale is eleven-item multiple choice diagnostic questionnaire (range 0-60), which psychiatrists use to measure the severity of manic episodes in children and young adults. Typically, 20 is the minimum score required for mania. Higher scores represent increased severity of mania symptoms. (NCT00183443)
Timeframe: Week 12

Interventionunits on a scale (Mean)
DVP + Placebo5.7
DVP + Quetiapine11.1
DVP + Lithium10.0

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Global Assessment of Functioning

The Global Assessment of Functioning (GAF) is a numeric scale used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of an individual, e.g., how well one is meeting various problems-in-living. Scores range from 100 (extremely high functioning) to 1 (severely impaired). (NCT00183443)
Timeframe: Week 12

Interventionunits on a scale (Mean)
DVP + Placebo68.3
DVP + Quetiapine62.3
DVP + Lithium60.8

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Clinical Global Impression Scale for Bipolar Disorder (CGI-BD)

The Clinical Global Impression (CGI) rating scale was modified by Spearing and colleagues (1997) for use in bipolar disorder. CGI scales are measures of symptom severity, treatment response and the efficacy of treatments in treatment studies of patients with mental disorders. The revised CGI-Bipolar Version (CGI-BP) is effective in rating severity of manic and depressive episodes and the degree of change from the immediately preceding phase and from the worst phase of illness. The CGI-BP is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal, not ill) to 7 (very severely ill). Each component of the CGI is rated separately; the instrument does not yield a global score. Only severity of illness scores are reported. Increased scores represent increased illness severity (NCT00183443)
Timeframe: Week 12

Interventionunits on a scale (Mean)
DVP + Placebo1.58
DVP + Quetiapine2.54
DVP + Lithium2.32

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Hamilton Rating Scale for Depression (HAM-D,17)

The Hamilton Rating Scale for Depression is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. The questionnaire is designed for adults and is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation or retardation, anxiety, weight loss, and somatic symptoms. The 17-item Likert-type scale (range 0-50) includes eight questions with a 5-point scale (ranging from 0=not present to 4=severe) and nine items scored from 0 to 2. Higher scores indicate increased depression severity. The total sum of these 17 answers is used to arrive at the final score: normal (0-7), mild (8-13), moderate (14-18), severe (19-22), or very severe (>=23). (NCT00183443)
Timeframe: Week 12

Interventionunits on a scale (Mean)
DVP + Placebo13.2
DVP + Quetiapine18.3
DVP + Lithium18.8

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Social and Occupational Functioning Assessment Scale (SOFAS)

The Social and Occupational Functioning Assessment Scale (SOFAS) provides a rating of global social and occupational function independent of clinical symptoms. SOFAS is provided in the Diagnostic and Statistical Manual (DSM-IV) as an Axis V measure. The SOFAS is a global rating of current functioning, which is scored positively on a scale from 0 to 100. Higher scores represent higher levels of functioning. This instrument is a one-item rating of consumer functioning. (NCT00183443)
Timeframe: Week 12

Interventionunits on a scale (Mean)
DVP + Placebo68.2
DVP + Quetiapine62.1
DVP + Lithium59.8

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Percentage of Participants With Clinical Global Impression for Bipolar Disorders Overall Severity Remission (Score <=2 at Week 8)

"0-7 scale: rated on the following seven-point scale:) 0=not assessed, 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.~This rating is based upon observed and reported symptoms, behavior, and function in the past seven days." (NCT00186043)
Timeframe: Week 8

Interventionpercentage of participants (Number)
Quetiapine/Seroquel47
Placebo21

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Percentage of Participants With >=50% Improvement From Baseline in Clinical Global Impression for Bipolar Disorders Overall Severity

"0-7 scale: rated on the following seven-point scale:) 0=not assessed, 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.~This rating is based upon observed and reported symptoms, behavior, and function in the past seven days." (NCT00186043)
Timeframe: Baseline and 8 weeks

Interventionpercentage of participants (Number)
Quetiapine/Seroquel37
Placebo21

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Percentage of Participants With 50% Improvement From Baseline in Both Montgomery Asberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS) Scores

MADRS assesses change from baseline to endpoint. Higher score indicates more severe depression; each item yields a score of 0 to 6. Overall score ranges: 0 to 60. Questions following symptoms 1. Apparent sadness 2. Reported sadness 3. Inner tension 4. Reduced sleep 5. Reduced appetite 6. Concentration difficulties 7. Lassitude 8. Inability to feel 9. Pessimistic thoughts 10. Suicidal thoughts. Cutoff points:0 to 6- normal/symptom absent; 7 to 19- mild depression; 20 to 34- moderate depression; >34- severe depression. YMRS:a 11-item clinician-admin instrument assesses severity of mania. Symptoms rated: Elevated mood, Increased motor activity/energy, Sexual interest, Sleep, irritability, Speech, language/thought disorder, Content, Disruptive/aggressive behavior, Appearance, Insight. Each composed of five explicitly defined levels of severity. Severity ratings based on patient's subjective report of clinical condition during past 48 hours and clinician's observations. (NCT00186043)
Timeframe: Baseline and 8 weeks

Interventionpercentage of participants (Number)
Quetiapine/Seroquel47
Placebo29

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Change in Personal Evaluation of Transitions in Treatment (PETiT) Total Score

PETiT total score is the sum of the 30 items of PETiT questionnaire(range:0-60) on subjects perceived well-being, adherence, tolerability, satisfaction with treatment. Each item is rated by participant with a 3 point frequency scale:2=often, 1=sometimes, 0=never.Change in PETiT total score: total score at month 24 minus total score at randomization (NCT00206102)
Timeframe: Randomization to Month 24

Interventionunits on scale (Mean)
Quetiapine Fumarate1.2
Risperidone0.9

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Change in Simpson-Angus Scale (SAS) Total Score

SAS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4, higher scores indicate greater severity of Parkinsonian symptoms. Change : total score at month 24 minus total score at randomization. Increase in Change of total score indicates an increase in extrapyramidal motor symptoms. (NCT00206102)
Timeframe: Randomization to Month 24

Interventionunits on scale (Mean)
Quetiapine Fumarate-0.7
Risperidone-0.4

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Presence of a Posterior Subcapsular (P) Type Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale

Presence of P type of cataractogenic potential event in participant was defined if any LOCS II grades of 1, 2, 3 , 4 (with grade=0 at randomization) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0 is the best, 4 is the worst. (NCT00206102)
Timeframe: Randomization to Month 24

InterventionParticipants with P type event (Number)
Quetiapine Fumarate4
Risperidone7

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Change in Barnes Akathisia Rating Scale (BARS) Global Score

BARS global score is the 4th individual-item score on the BARS scale, the Global Assessment of Akathisia, with the score ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). Change : score at month 24 minus score at randomization. Increase in Change of BARS global score indicates an increase in akathisia. (NCT00206102)
Timeframe: Randomization to Month 24

Interventionunits of scale (Mean)
Quetiapine Fumarate-0.1
Risperidone0.1

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Change in the PANSS Psychopathology Subscale Score

"PANSS psychopathology subscale score equals sum of the 16-items scores(range:16-112). Each item has ( 1-7 units),1= absent psychosis symptom, 7= extreme symptom degree.Change in PANSS psychopathology subscale:score at month 24 minus score at randomization. Alleviation of general psychopathology symptoms are indicated by a negative change score." (NCT00206102)
Timeframe: Randomization to Month 24

Interventionunits on scale (Mean)
Quetiapine Fumarate-4.2
Risperidone-4.4

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Change in Abnormal Involuntary Movement Scale (AIMS) Total Score

AIMS total score is the sum of the 10 individual-item scores(range:0-40), with the score for each item ranging from 0 to 4. Change : total score at month 24 minus total score at randomization. Increase in Change of total score indicates an increase in abnormal voluntary movements. The lower score means lower intensity of abnormal voluntary Movements. 0 is best, 4 is worst. Increase in Change of total score indicates an increase in abnormal voluntary Movements. (NCT00206102)
Timeframe: Randomization to Month 24

Interventionunits on scale (Mean)
Quetiapine Fumarate-0.2
Risperidone0.1

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Change in the PANSS Negative Subscale Score

"PANSS Negative subscale score equals sum of the 7-items scores(range:7-49). Each item has ( 1-7 units), 1 indicates absent psychosis symptom, and 7 - extreme symptom degree. Change in PANSS Negative subscale score:score at month 24 minus score at randomization. Alleviation of negative psychotic symptoms are indicated by a negative change score." (NCT00206102)
Timeframe: Randomization to Month 24

Interventionunits on scale (Mean)
Quetiapine Fumarate-2.2
Risperidone-1.5

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Change in the PANSS Positive Subscale Score

"PANSS Positive subscale score equals sum of the 7-items scores(range:7-49). Each item has ( 1-7 units), 1 indicates absent psychosis symptom, and 7 - extreme symptom degree." (NCT00206102)
Timeframe: Randomization to Month 24

Interventionunits on scale (Mean)
Quetiapine Fumarate-2.7
Risperidone-2.8

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Change in the Positive and Negative Syndrome Scale (PANSS) Total Score

"PANSS total score equals sum of the 30-items scores (range: 30-210). Each item has ( 1-7 units), 1 indicates absent psychosis symptom, and 7 - extreme symptom degree. Change in PANSS total score : total score at month 24 minus total score at randomization.Alleviation of psychotic symptoms are indicated by a negative change in PANSS total score." (NCT00206102)
Timeframe: Randomization to Month 24

Interventionunits on scale (Mean)
Quetiapine Fumarate-9.1
Risperidone-8.6

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Number of Participants With Potential Extrapyramidal Symptoms (EPS)

Number of participants with adverse events potentially associated with EPS collected by MedDRA Preferred Terms as akathisia, bradykinesia, drooling, dyskinesia, dystonia, extrapyramidal disorder, grimacing, muscle rigidity, parkinsonism, restlessness, tardive dyskinesia, tremor (NCT00206102)
Timeframe: From start of the study treatment to last dose plus 30 days

InterventionParticipants (Number)
Quetiapine Fumarate73
Risperidone106

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Number of Relapses of Schizophrenia or Schizoaffective Disorder

Relapse is defined as a hospital stay for psychiatric symptoms or a 2-point increase from baseline in the CGI severity score. CGI-S score ranges from 0-7 with 0 = Not Assessed, 1 = Normal, not at all and 7 = Among the most extremely ill subjects. (NCT00206102)
Timeframe: At Month 24

InterventionRelapses (Number)
Quetiapine Fumarate24
Risperidone33

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Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score

CGI-S score is accessed on a seven-graded scale ranging from most extremely ill/ very much worse (7) to normal/very much improved (1) , 1 is best. Change : score at month 24 minus score at randomization. (NCT00206102)
Timeframe: Randomization to Month 24

Interventionunits on scale (Mean)
Quetiapine Fumarate-0.7
Risperidone-0.5

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Presence of a Cortical (C) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the Lens Opacities Classification System II (LOCS II ) Grading Scale

Presence of C type of cataractogenic potential event in participant was defined if any LOCS II grades of 2, 3, 4, 5 (with any grade of 0, trace,1 at randomization) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0= no cataract; 5 is worst. There are no subscales. 0 is the best, 5 is the worst. (NCT00206102)
Timeframe: Randomization to Month 24

InterventionParticipants with C type event (Number)
Quetiapine Fumarate2
Risperidone8

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Presence of a Nuclear Opalescence (N) Type of Cataractogenic Potential Events in Participants as Assessed and Agreed by 2 Independent, Treatment-masked Ophthalmologists Using the LOCS II Grading Scale

Presence of N type of cataractogenic potential event in Participants was defined if any LOCS II grades of 2, 3, 4 (with grade at rand equals 0,1), or if the LOCS II grades of 3,or 4 (with grade at randomization=2) assessed and agreed by 2 independent, treatment-masked ophthalmologists at any post-randomization assessment in one or both eyes. 0 is the best, 4 is the worst. (NCT00206102)
Timeframe: Randomization to Month 24

InterventionParticipants with N type event (Number)
Quetiapine Fumarate0
Risperidone2

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Mean Relapse Free Period(Risperidone LAI Versus Quetiapine)

Relapse was defined as meeting any of the predefined criteria (adapted from Csernansky et al., 2002) on 2 consecutive evaluations during treatment, 3 to 5 days apart. The relapse rate in each treatment arm was estimated using the Kaplan-Meier method. (NCT00216476)
Timeframe: Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier)

Interventiondays (Mean)
Risperidone LAI607
Quetiapine533

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Mean Relapse Free Period (Exploratory/Aripiprazole)

As for risperidone and quetiapine, relapse was defined as meeting any of the predefined criteria (adapted from Csernansky et al., 2002) on 2 consecutive evaluations during treatment, 3 to 5 days apart. Since aripiprazole was new on the market at the time the study was conducted, this aripiprazole analysis was exploratory. (NCT00216476)
Timeframe: Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier)

Interventiondays (Mean)
Aripiprazole314

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Change From Baseline to Endpoint in Total Positive and Negative Syndrome Scale (PANSS) Score

"The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item PANSS scale. The PANSS scale provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, i.e., the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items).~Each item of the scale is to be scored on a scale of 1 (absent) to 7 (extreme)." (NCT00216476)
Timeframe: Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier)

Interventionunits on a scale (Mean)
Risperidone LAI-9.3
Quetiapine-1.1
Aripiprazole-7.7

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Change From Baseline to Endpoint in Clinical Global Impression Scale (CGI) Score

The 7-point CGI scale of Severity (CGI-S) was used to assess the severity of a subject's psychotic condition (0= normal, not at all ill, 1= borderline, etc. and 6= among the most extremely ill subjects). (NCT00216476)
Timeframe: Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Month 24 or earlier)

Interventionunits on a scale (Mean)
Risperidone LAI-0.3
Quetiapine0.1
Aripiprazole-0.1

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Change From Baseline to Endpoint in Short-Form Health Survey 12 (SF-12) Scores

Quality of life was assessed by means of the 12-item SF-12® survey. Two parameters, i.e., PCS (physical component summary) and MCS (mental component summary) were calculated. Both components scores range from 0 to 100 with higher scores indicating better QOL. (NCT00216476)
Timeframe: Assessed at the moment the subject was randomized to a treatment arm (baseline visit) and after 1, 3, 6, 12, 18, and 24 months of treatment

,,
Interventionunits on a scale (Mean)
PCS scoreMCS score
Aripiprazole2.44.9
Quetiapine1.02.7
Risperidone LAI2.13.2

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Number of Patients Withdrawn Due to AEs.

Number of subjects who withdrew from the study due to AEs. (NCT00227305)
Timeframe: during 26 weeks of treatment

InterventionParticipants (Number)
Quetiapine37

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Categorical Change From OL Baseline to Week 26 in Simpson-Angus Scale (SAS)Total Score

"Number of patients for who the total score is estimated as worse. The Simpson Angus Scale (SAS)is used to assess Parkinsonian symptoms (a type of movement disorders). The score was calculated as the sum of the 10 individual item scores. Total Score ranges from 0-40 (normal to worse). Individual item scale range from 0 to 4 (normal to worse).~Improved define as those with a <= -1 change in SAS total score. Worsened defined as those with a >=1 change in SAS total score." (NCT00227305)
Timeframe: OL baseline to week 26

InterventionParticipants (Number)
Quetiapine34

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Categorical Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Score

"Number of patients for who the total score is estimated as worse. The Barnes Akathisia Rating Scale (BARS) global score is used to measure Akathisia (a type of movement disorders). BARS is the item 4 score from the BARS assessment. The scale is from a range 0-5 (normal to worse). Change from baseline in BARS global score increase means worse.~Improved defined as those with a <= -1 change in BARS global score. Worsened defined as those with a >= 1 change in BARS global score." (NCT00227305)
Timeframe: 26 weeks of treatment

InterventionParticipants (Number)
Quetiapine11

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Incidence and Nature of Adverse Events (AEs)

Number of participants that had AE which occurred from first dose date to last dose date + 30 days. (NCT00227305)
Timeframe: from open label to week 26+ 30 days

InterventionParticipants (Number)
Quetiapine321

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Changes in Tanner Stage

"Category shift in Tanner stage. Number of subjects who experienced the change is presented.~Tanner stages (I-V) was used to characterize physical development in children, adolescents, and adults. The stages was based on external primary and secondary sex characteristics, such as the size of the breasts, genitalia, and development of pubic hair. Tanner stage is considered going up when the organs grow bigger." (NCT00227305)
Timeframe: Change from OL baseline to week 26 in the Tanner stage

InterventionParticipants (Number)
Quetiapine70

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Changes in Laboratory Test Results (Prolactin)

"Clinical important shift to high prolactin from open-label (OL) baseline to week 26.~High Prolactin is defined as value >26 ug/L for female and value >20 ug/L for male." (NCT00227305)
Timeframe: Duration of study participation

InterventionParticipants (Number)
Quetiapine19

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Change From OL Baseline in Supine Systolic BP.

Changes from OL baseline to the final visits in Supine systolic BP (mmHg) (NCT00227305)
Timeframe: OL baseline to Week 26

InterventionmmHg (Mean)
Quetiapine1.7

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Change From OL Baseline in Supine Diastolic BP.

Changes from OL baseline to the final visits in Supine diastolic BP (mmHg) (NCT00227305)
Timeframe: OL baseline to Week 26

InterventionmmHg (Mean)
Quetiapine1.3

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Change From Baseline in Weight

Number with 7% or more increase (without adjustment for normal growth) (NCT00227305)
Timeframe: 26 weeks of treatment

InterventionParticipants (Number)
Quetiapine134

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Change From Baseline in Supine Pulse

Change from OL baseline to week 26 in supine pulse (bpm) (NCT00227305)
Timeframe: OL baseline to week 26

Interventionbpm (Mean)
Quetiapine0.8

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Change From Baseline in Children's Global Assessment Scale (CGAS) Score

Children's Global Assessment Scale (CGAS) is used to rate the general functioning of children under the age of 18. It is the 100-point single-item score that was collected in the Clinical Report Form (CRF), scored from 0-100 (worse to normal). (NCT00227305)
Timeframe: OL Baseline to Week 26

Interventionunits on a scale (Mean)
Quetiapine7

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Change in Mean Q-LES-Q Score From Baseline to Endpoint.

"Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) a self-rated 14-item questionnaire designed to assess the degree of enjoyment and satisfaction of various aspects of daily functioning. Each question is rated on a 5-point scale with scores ranging from 1 = very poor to 5 = very good. The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. A lower score indicates worsening and a higher score indicates better quality of life." (NCT00292370)
Timeframe: From Baseline (week 8) to Endpoint (week 16 or termination)

,
Interventionunits on a scale (Mean)
Baseline Q-LES-QEndpoint Q-LES-Q
Arm 2 OL Paroxetine + DB Placebo37.8538.22
Arm 3: OL Paroxetine + DB Quetiapine40.4441.06

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Change in Mean Sheehan Disability Scale (SDS) Scores From Baseline to Endpoint.

The SDS is a brief 3-item questionnaire that was used as a self-report to assess the degree to which psychiatric symptoms have disrupted the patient's work, family/home responsibilities, and social life. Score ranging from 0 (no impairment) to 30 (most severe). (NCT00292370)
Timeframe: Baseline (week 8) to Endpoint (week 16 or termination)

,
Interventionunits on a scale (Mean)
Baseline SDS-WSEndpoint SDS-WSBaseline SDS-SLEndpoint SDS-SLBaseline SDS-FLEndpoint SDS-FL
Arm 2 OL Paroxetine + DB Placebo5.074.586.675.925.855.39
Arm 3: OL Paroxetine + DB Quetiapine4.444.665.644.954.724.61

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Change in Mean Scores of Pittsburgh Sleep Quality Index (PSQI) From Baseline to Endpoint.

The PSQI is one of the most frequently used self-rated sleep questionnaire. Total score ranging from 0 to 21. Higher scores are representing worse sleep quality. (NCT00292370)
Timeframe: From Baseline (week 8) to Endpoint (week 16)

,
Interventionunits on a scale (Mean)
Baseline PSQIEndpoint PSQI
Arm 2 OL Paroxetine + DB Placebo11.608.70
Arm 3: OL Paroxetine + DB Quetiapine12.6913.19

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Change in CGI-I

Clinical Global Impressions Scale and Global Improvement Subscales (CGI-I) is a 7-point scale which was used to assess overall improvement. The scores range from 1 to 7, with 1 indicating very much improved and 7 indicating very much worse. (NCT00292370)
Timeframe: From Baseline (week 8) to Endpoint (week 16 or termination)

,
Interventionunits on a scale (Mean)
Baseline CGI-IEndpoint CGI-I
Arm 2 OL Paroxetine + DB Placebo3.562.61
Arm 3: OL Paroxetine + DB Quetiapine3.362.22

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Change in Clinician-Administered PTSD Scale for DSM-IV Total Score.

The Clinician-Administered PTSD Scale for DSM-IV (CAPS) is described in the National Center for PTSD Instruction Manual (November 2000) as a semi-structured clinical interview designed to assess the seventeen symptoms for Post Traumatic Stress Disorder (PTSD) outlined in the DSM-IV, along with five associated features. Ratings are made on a 5 point continuum from the lowest frequency or intensity to the highest. Total CAPS score is a summed score that ranges from 0 to 136 where 0 is asymptomatic and higher scores equal more severe PTSD symptomatology. Also, a change in total CAPS score of 15 points was proposed as clinically significant change. (NCT00292370)
Timeframe: From baseline (week 8) to endpoint (week 16 or termination)

,
Interventionunits on a scale (Mean)
CAPS Total BaselineCAPS Total Endpoint
Arm 2 OL Paroxetine + DB Placebo72.1567.90
Arm 3: OL Paroxetine + DB Quetiapine68.7851.52

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Change in Arizona Sexual Experience Scale (ASEX)

The ASEX is a brief 5-item rating scale that assesses five global aspects of sexual dysfunction. Score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences. (NCT00292370)
Timeframe: From Baseline (week 8) to Endpoint (week 16 or termination)

,
Interventionunits on a scale (Mean)
Baseline ASEXEndpoint ASEX
Arm 2 OL Paroxetine + DB Placebo22.0021.93
Arm 3: OL Paroxetine + DB Quetiapine17.8816.94

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Change in Mean PANSS Total and Subscores From Baseline to Endpoint

Positive and Negative Symptom Scale (PANSS). A 30-item clinician administered rating scale for which positive, negative and general subscales are scored from 30 to 210 with a higher scores indicating greater severity of symptoms. (NCT00292370)
Timeframe: Baseline (week 8) to Endpoint (week 16 or termination)

,
Interventionunits on a scale (Mean)
Baseline Total PANSSEndpoint Total PANSS
Arm 2 OL Paroxetine + DB Placebo46.6343.92
Arm 3: OL Paroxetine + DB Quetiapine47.7642.24

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Change in Total Mean Hamilton Rating Scale for Depression (HAMD) Scores

Hamilton Rating Scale for Depression (HAMD) was used as a measure of depression. Scoring is based on a 17-item scale. Eight items are scored on a 5 point scale from 0= not present to 4= severe. The scoring is based on the first 17 items. Scores of 0-7 normal, 8-13 is mild depression, 14-18 moderate depression, 19-22 severe depression and 23 and above very severe depression; the maximum score being 52 on the 17-point scale. (NCT00292370)
Timeframe: From Baseline (week 8) to Endpoint (week 16 or Termination)

,
Interventionunits on a scale (Mean)
Baseline HAMDEndpoint HAMD
Arm 2 OL Paroxetine + DB Placebo14.6012.29
Arm 3: OL Paroxetine + DB Quetiapine13.849.29

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Change in Total Mean Davidson Trauma Scale (DTS)

"The DTS is a 17-item self-rated scale that measures the frequency and the severity of DSM-IV PTSD symptoms. Items are rated on 5-point frequency (0 = not at all to 4 = every day) and severity scales (0 = not at all distressing to 4 = extremely distressing). The DTS yields a frequency score (ranging from 0 to 68), severity score (ranging from 0 to 68), and total score (ranging from 0 to 136). A higher score indicates higher frequency and severity. It can be used to make a preliminary determination about whether the symptoms meet DSM criteria for PTSD. Scores can also be calculated for each of the 3 PTSD symptom clusters (i.e., B, C, and D)." (NCT00292370)
Timeframe: From Baseline (week 8) to Endpoint (week 16 or Termination)

,
Interventionunits on a scale (Mean)
Baseline DTSEndpoint DTS
Arm 2 OL Paroxetine + DB Placebo82.1984.06
Arm 3: OL Paroxetine + DB Quetiapine77.2561.50

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Substantial Clinical Deterioration Measured by Psychotic Symptoms

Brief Psychiatric Rating Scale (BPRS) psychosis cluster. Score range is based on the score range for individual items rather than the factor total because is factors have different numbers of items. Score range is 1 -7 where 1 + no symptomatology and 7 = very severe symptoms. (NCT00330863)
Timeframe: Measured throughout study up to 30 months

Interventionunits on a scale (Least Squares Mean)
Injectable1.8
Oral2.0

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Number of Patients Discontinuing From the Study

(NCT00330863)
Timeframe: Measured throughout study up to 30 months

Interventionparticipants (Number)
Injectable81
Oral80

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Side Effects and Metabolic Measures

The highest severity of each of 24 adverse event (AE) that was assessed.over the 30 month study period. The mean severity on a scale of 1 (none) to 4 very severe symptom was recorded at each biweekly visit. Results for each variable are summarized over time so that each subject has a single mean severity rating for each AE. There is no named scale. Each of the side effects measured is named in ways that are clear to medical readers e.g anorexia. The range is 1 none to 4 very severe. Therefore, a higher scale score is worse. (NCT00330863)
Timeframe: Measured throughout study up to 30 months

,
Interventionunits on a scale (Mean)
Bruising easilyRashUrticaria (hives, itching)Blurred visionsedation/drowsinessRestlessnessInsomniaMalaise (weakness, fatigue)StiffnessTremorDizzinessHeadacheFeverSore ThroatDry MouthHypersalivationEnuresisConstipationDiarrheaAnorexia (loss of appetite)NauseaVomitingMenstrual IrregularityBreast tenderness/galactorrhea
Injectable1.431.531.601.762.342.482.382.222.011.771.821.991.271.642.361.761.631.751.651.891.781.481.621.39
Oral1.481.441.711.912.532.432.362.141.971.751.781.891.241.572.251.841.561.641.681.691.721.511.551.32

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Change From Baseline in Suicidal Thoughts as Measured by Montgomery-Asberg Depression Rating Scale (MADRS) Item 10

The suicide item is a single item of the Montgomery-Asberg Depression Rating Scale with a range of values from 0 to 6, worst value 6, best value 0 (NCT00388973)
Timeframe: Baseline to Week 9

Interventionunits on scale (Median)
Quetiapine XR0
Placebo0

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Tolerability as Measured by Adverse Event Withdrawals During Treatment

(NCT00388973)
Timeframe: Baseline to Week 9

InterventionParticipants (Number)
Quetiapine XR16
Placebo7

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Change From Baseline in Somatic Symptoms Cluster From the Hamilton Anxiety Scale (HAM-A)

The Somatic symptom Cluster of the Hamilton Anxiety Scale is a 7 item cluster associated with somatic symptoms *somatic muscular, somatic sensory, cardiovascular system, respiratory system, gastrointestinal system, genitourinary system, autonomic system) with a range of values from 0 to 28, worst value 28, best value 0 (NCT00388973)
Timeframe: Baseline to Week 9

Interventionunits on scale (Median)
Quetiapine XR-4
Placebo-2

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Change From Baseline in Sleep Quality as Measured by the Pittsburgh Sleep Quality Index

The Pittsburgh Sleep Quality Index is an eighteen questionnaire scored with 7 sleep component scores each on a 0 to 3 scale, total score range from 0 to 21, worst value 21, best value 0 (NCT00388973)
Timeframe: Baseline to Week 9

Interventionunits on scale (Least Squares Mean)
Quetiapine XR-6
Placebo-3

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Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to Week 9.

MADRS total score (0-60 units), where lower scores indicate less depressive symptoms, calculated as Week 9 value - baseline value. (NCT00388973)
Timeframe: Baseline to Week 9

Interventionunits on scale (Least Squares Mean)
Quetiapine XR-16
Placebo-9

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Change From Baseline in Anxiety Symptoms Measured by Hamilton Anxiety 14 Item Scale (HAM-A)

Change in HAM-A total score (total score 0-56), calculated as Week 9 value - baseline value, where lower scores indicate less anxiety. (NCT00388973)
Timeframe: Baseline to Week 9

Interventionunits on a scale (Least Squares Mean)
Quetiapine XR-11
Placebo-5

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Change From Baseline for Satisfaction With Medication From Quality of Life, Enjoyment, Satisfaction Questionaire (Q-LES-Q)

Item 15 the Quality of Life, Enjoyment Satisfaction Questionnaire (score 1 least -5 best) on Q-LES-Q, calculated as Week 9 value - baseline value (NCT00388973)
Timeframe: Baseline to Week 9

Interventionunits on scale (Median)
Quetiapine XR0
Placebo0

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Change in the Hamilton Rating Scale for Anxiety (HAM-A) Total Score

HAM-A total score ( 0-56 units), 0 is the best, Change : score at week 9 minus score at randomization (NCT00389064)
Timeframe: Randomization to Week 9

Interventionunits on scale (Least Squares Mean)
Quetiapine XR-14.97
Placebo-7.21

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Change in the Clinical Global Impression - Severity of Illness (CGI-S) Score

CGI-S score is accessed on a seven-graded scale ranging from most extremely ill/ very much worse (7) to normal/very much improved (1) , 1 is best Change : score at week 9 minus score at randomization (NCT00389064)
Timeframe: Randomization to Week 9

Interventionunits on scale (Least Squares Mean)
Quetiapine XR-1.76
Placebo-0.59

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Hamilton Rating Scale for Anxiety (HAM-A) Response.

HAM-A response, defined as 50% or greater reduction from randomization in HAM-A total score. (NCT00389064)
Timeframe: Week 9

InterventionNumber of participants. (Number)
Quetiapine XR152
Placebo54

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Number of Patients Reaching Hamilton Rating Scale for Anxiety (HAM-A) Remission

"HAM-A remission, defined as HAM-A total score less or equal to 7. An indicator of HAM-A remission is calculated as:~If HAM-A total score≤7, THEN indicator=1~If HAM-A total score >7, THEN indicator=0" (NCT00389064)
Timeframe: Week 9

InterventionNumber of participants. (Number)
Quetiapine XR89
Placebo29

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Safety and Well Tolerated as Measured by Extra Pyramidal Symptoms (EPS)

Number of patients have adverse events associated with EPS (NCT00389064)
Timeframe: From start of the study teatment to last dose plus 30 days

InterventionPatients (Number)
Quetiapine XR12.00
Placebo5.00

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Safety and Well Tolerated as Measured in Adverse Event

Number of patients have at least one adverse event (NCT00389064)
Timeframe: From the start of treatment to last dose plus 30 days

InterventionParticipants (Number)
Quetiapine XR145.00
Placebo114.00

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Change in Somatic Symptoms as Measured by HAM-A Somatic Cluster Score

HAM-A somatic cluster score (0-28), 0 is the best Change : score at week 9 minus score at randomization (NCT00389064)
Timeframe: Randomization to Week 9

Interventionunits on scale (Least Squares Mean)
Quetiapine XR-6.05
Placebo-3.37

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Change in Psychic Anxiety Factor as Measured by HAM-A Psychic Cluster Score

HAM-A psychic cluster score ( 0-28), 0 is the best Change : score at week 9 minus score at randomization (NCT00389064)
Timeframe: Randomization to Week 9

Interventionunits on scale (Least Squares Mean)
Quetiapine XR-8.88
Placebo-3.81

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Change in Montgomery-Asberg Depression Rating Scale (MADRS)

MADRS total score (0-60), 0 is best Change : score at week 9 minus score at randomization (NCT00389064)
Timeframe: Randomization to week 9

Interventionunits on scale (Least Squares Mean)
Quetiapine XR-6.94
Placebo-2.22

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Change in the Visual Analogue Scale (VAS) Measuring Pain

Visual Analogue Scale (VAS) measuring pain (0-100 mm), 0 is best Change : scale at week 9 minus scale at randomization (NCT00389064)
Timeframe: Randomization to week 9

Interventionmm (Least Squares Mean)
Quetiapine XR-17.95
Placebo-6.18

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Change in Percent Days of Cannabis Use Per Week

Change in percent days of cannabis use per week from baseline to week 16. (NCT00393978)
Timeframe: 16 weeks

Interventioncannabis use (Mean)
Quitiapine and Placebo-29.9
Quetiapine and Topiramate-43.5

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Change in Joints Per Week

Change in timeline follow-back self-reported of joint equivalents per week from baseline to 16 weeks. (NCT00393978)
Timeframe: 16 weeks

Interventionjoints (Mean)
Quitiapine and Placebo-10.1
Quetiapine and Topiramate-10.7

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Primary Measure: Young Mania Rating Scale (YMRS) Primary Endpoint: Day 7

Minimum: 0 Maximum: 60 Higher scores indicate worse outcome (NCT00397020)
Timeframe: Day 7

Interventionunits on a scale (Mean)
1 Divalproex ER14.8
2 Quetiapine Fumarate13.9

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Number of Participants With a Response

Number of participants with response defined as an average of 50% (or greater) reduction in the subject's baseline HRSD-25 score over three consecutive weeks and a current YMRS score ≤ 10 (NCT00411463)
Timeframe: Week 12

InterventionParticipants (Count of Participants)
Psychotherapy4
Medication3

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Quality of Life (QOL) Collected Using the Q-LES-Q (Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form)

The total score is derived by summing item scores 1 to 14. Higher scores are indicative of greater enjoyment or satisfaction in each domain. The Q-LES-Q-SF % maximum total score is calculated as 100% × (Q-LES-Q-SF total score - 14) / 56, and can range from 0% to 100%. (NCT00411463)
Timeframe: Baseline and Week 12

,
Interventionscores on Q-LES-Q scale (Least Squares Mean)
BaselinePost-Intervention
Medication40.048.7
Psychotherapy34.637.0

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Number of Participants With Greater Than or Equal to 50% Reduction in Depression Scores, With a Mania Score Less Than or Equal to 10

Overall response rates (defined as greater than or equal to 50% reduction in depression scores without an increase in mania scores) were 29% (n=4) in the IPSRT group and 27% (n=3) in the quetiapine group. HRSD-25 scores are based on first 17 responses. Eight items are scored on a 5-pt scale, from 0 (not present) to 4 (severe.) Other nine items on the assessment are scored from 0-2. The higher the score on the HRSD-25, the worse the outcome is considered to be. A score of 0-7 is considered to be normal; 8-13 indicates mild depression, 14-18 indicates moderate depression, 19-22 indicates severe depression, and any score greater than or equal to 23 indicates very severe depression. The YMRS is an 11 point assessment. There are 4 items assessed on a scale ranging from 0 to 8 and the other 7 items are graded on a 0 to 4 scale. As with the HRSD, the higher the score on the YMRS indicates the presence of more or more severe manic symptoms and is associated with a worse outcome. (NCT00411463)
Timeframe: Week 12

,
Interventionparticipants (Number)
50% reduction in HRSD 25 score and YMRS <= 10Non-responder
Medication38
Psychotherapy410

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Descriptive Measures of the Feasibility of IPSRT-BPII

Feasibility was assessed by ability to enroll, randomize, and retain participants in this trial. Completion of the study was used as evidence of feasibility. (NCT00411463)
Timeframe: Week 12

InterventionParticipants (Count of Participants)
Psychotherapy11
Medication8
Total19

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Efficacy Failure, Defined as Psychiatric Hospitalization, a 25 Percent Increase From Baseline on the Positive and Negative Syndrome Scale or Substantial Clinical Deterioration on the Clinical Global Impressions-Change (CGI-C)

(NCT00423878)
Timeframe: Measured at Month 6

Interventionparticipants (Number)
Switch Group22
Stay Group18

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Change in Non-HDL Cholesterol Level for Patients Assigned to Stay and Patients Assigned to Switch Over 24 Weeks

Change in non-HDL cholesterol measured at baseline and every 4 weeks for 24 weeks. The efficacy analysis corresponded to a comparison of change in non-HDL cholesterol from baseline to 24 weeks between treatment groups (stay versus switch). Repeated measurements mixed effects linear models were fit for the primary analysis. (NCT00423878)
Timeframe: 24 weeks

Interventionmg/dL non-HDL cholesterol (Least Squares Mean)
Switch Group-20.2
Stay Group-10.8

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Insomnia Severity Index (ISI)

ISI total score; this scale assesses for global insomnia severity (range 0-24). Higher scale scores indicate higher insomnia severity. (NCT00434876)
Timeframe: Baseline, weeks 1, 3, 5, and 7 of treatment.

,
Interventionunits on a scale (Mean)
ISI (baseline)ISI (week 7)
Placebo14.806.70
Quetiapine XR17.005.40

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Pittsburgh Sleep Quality Index (PSQI)

"PSQI total score (range 0-21). A PSQI total score > 5 indicates insomnia, with higher scores denoting a decrease in sleep quality.~The PSQI global score assesses for the overall quality of sleep and is computed by adding the 7 component scale scores. This widely used 19-item self-rated scale evaluates the subjective quality of sleep over the last 4 weeks. The PSQI was administered at baseline, and weeks 4, and 9." (NCT00434876)
Timeframe: Baseline, weeks 4, and 9.

,
Interventionunits on a scale (Mean)
PSQI (baseline)PSQI (week 4)PSQI (week 9)
Placebo14.6013.8013.80
Quetiapine XR14.7013.2014.50

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Wake After Sleep Onset Time (WASO) From an In-laboratory Polysomnogram.

The amount of time spent awake after initially falling asleep and before final awakening (in minutes). None to a fewer minutes is better (than a higher number of minutes). (NCT00434876)
Timeframe: Baseline, and week 8

,
Interventionminutes (Mean)
WASO (baseline)WASO (week 8)
Placebo61.1766.99
Quetiapine XR101.8760.71

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Sleep Efficiency (From an In-laboratory Polysomnogram)

The fraction of time spent asleep to the total time in bed (%). (NCT00434876)
Timeframe: Baseline, and week 8 of treatment.

,
Interventionpercentage (Mean)
Sleep Efficiency (baseline)Sleep Efficiency (after 8 weeks of treatment)
Placebo78.6382.80
Quetiapine XR70.7079.45

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The Number of Standard Drinks/Day Will Serve as the Primary Outcome Measure.

(NCT00457197)
Timeframe: 12 weeks

Interventiondrinks (Least Squares Mean)
Placebo10.6
Quetiapine8.09

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Young Mania Rating Scale (YMRS)

"This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe).~Score:~Minimum: 0 Maximum: 60 Lower score associated with better outcome" (NCT00457197)
Timeframe: 12 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo8.70
Quetiapine8.48

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Aspartate Aminotransferase (AST)

AST is a liver enzyme measurement (IU/I) (NCT00457197)
Timeframe: 12 weeks

InterventionIU/I (Least Squares Mean)
Placebo29.7
Quetiapine31.1

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Alanine Aminotransferase (ALT)

ALT is a liver enzyme measurement (IU/I). (NCT00457197)
Timeframe: 12 weeks

InterventionIU/I (Least Squares Mean)
Placebo25.1
Quetiapine30.4

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Gamma-glutamyltransferase (GGT)

GGT is a liver enzyme measurement (IU/I) (NCT00457197)
Timeframe: 12 weeks

InterventionIU/I (Least Squares Mean)
Placebo66.6
Quetiapine66.0

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Hamilton Rating Scale for Depression (HRSD)

"The assessment is a clinician administered rating of depression with 17 questions. The total score is indicates level of depression within the following ranges: none (0-5), mild (6-10), moderate (11-15), severe (16-20), and very severe (21+).~Scale:~Minimum: 0 Maximum: 50 Lower score associated with better outcome" (NCT00457197)
Timeframe: 12 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo10.9
Quetiapine10.3

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Inventory of Depressive Symptomatology-Self Report (IDS-SR)

"IDS-SR is a self reported 30 item assessment to diagnose a major depressive episode.~Score:~Minimum: 0 Maximum: 84 Lower score associated with better outcome" (NCT00457197)
Timeframe: 12 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo19.0
Quetiapine21.9

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Penn Alcohol Craving Scale (PACS)

"The PACS is a five-item self-administered instrument for assessing craving, frequency, intensity, and duration of thoughts about drinking are assessed along with ability to resist drinking~Score:~Minimum: 0 Maximum: 30 Lower score associated with better outcome." (NCT00457197)
Timeframe: 12 weeks

Interventionunits on a scale (Least Squares Mean)
Placebo14.1
Quetiapine12.3

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Percent of Heavy Drinking Days

(NCT00457197)
Timeframe: 12 weeks

Interventiondrinks (Least Squares Mean)
Placebo28.8
Quetiapine20.8

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Change in the PANSS-EC Score Among Participants From Baseline to 2 Hours After Administration of the Medication.

The PANSS-EC is the Positive and Negative Syndrome Score - Excited Component, which includes 5 items (excitement, hostility, tension, uncooperative, poor impulse control), which are rated from 1 (not present) to 7 (extremely severe); scores range from 5 to 35; mean scores ≥ 20 clinically correspond to severe agitation. This set of items detects differences between drug and placebo when evaluating acute agitation and aggression in psychiatric patients with different psychiatric pathologies (Montoya, A; Villadares, A; Lizan, L, et al., 2011). (NCT00457366)
Timeframe: Two hours

Interventionscore on a scale (Least Squares Mean)
Cocktail-11.0
Quetiapine-11.5

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Hamilton Anxiety Scale (HAM-A)

The Hamilton Anxiety Scale consists of 14 items, each defined by a series of symptoms. Similar to the HAM-D, each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe) (Guy, 1976). A total score is derived from the summed items (min=0, max=56) with higher scores indicative of greater anxiety (a poor outcome). The HAM-A was assessed at study weeks 4, 6, 8, 10, and 12. Analyses averaged across these weeks. (NCT00498628)
Timeframe: Weeks 4, 6, 8, 10, and 12

Interventionscore on a scale (Least Squares Mean)
Quetiapine Fumerate Plus Medical Management2.4
Sugar Pill Plus Medical Management3.0

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Drinks Per Drinking Day

Timeline Follow Back daily drinking data used to calculate the weekly mean drinks per drinking day (NCT00498628)
Timeframe: Study Weeks 3-11

Interventiondrinks per drinking day (Least Squares Mean)
Quetiapine Fumerate Plus Medical Management6.2
Sugar Pill Plus Medical Management6.3

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Drinks Per Day

Timeline Follow Back daily drinking data used to calculate the weekly mean drinks per day (NCT00498628)
Timeframe: Study Weeks 3-11

Interventiondrinks per day (Least Squares Mean)
Quetiapine Fumerate Plus Medical Management4.3
Sugar Pill Plus Medical Management4.4

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Drinking Consequences Score

Drinkers Inventory of Consequences (DrInC) - Alcohol-related problems are determined using the DrInC (Miller et al., 1995). The DrInC is a self-administered 50-item questionnaire designed to measure adverse consequences of alcohol abuse in five areas: Interpersonal, Physical, Social, Impulsive, and Intrapersonal. Each scale provides a lifetime and past 3-month measure of adverse consequences, and scales can be combined to assess total adverse consequences. We used a modified version of the DrInC that just included the 45-items that summed the Interpersonal, Physical, Social, and Impulsivity items. This total score (min=0, max=135) was analyzed in this study with high scores indicative of more alcohol-related consequences (a poor outcome for a given study participant). The DrInC was assessed at study weeks 6 and 12. Analyses averaged across these weeks. (NCT00498628)
Timeframe: Weeks 6 & 12

Interventionscore on a scale (Least Squares Mean)
Quetiapine Fumerate Plus Medical Management18.5
Sugar Pill Plus Medical Management22.5

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Percent Subjects Abstinent

Timeline Follow Back data used to calculate the % of subjects that maintained abstinence weeks 3-11. (NCT00498628)
Timeframe: Study Weeks 3-11

InterventionParticipants (Count of Participants)
Quetiapine Fumerate Plus Medical Management12
Sugar Pill Plus Medical Management12

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Quality of Life SF-12 - Physical Aggregate Score

The SF-12 will be used to assess overall health status. The SF-12 is a 12-item questionnaire developed in 1994 as a shorter alternative to the SF-36 to reproduce the physical and mental health summary measures with at least 90% accuracy. We calculated the physical and mental component summary scores which were both converted to T-scores (min=0, max=100) normed to the general population such that a T=50 is the average score in the general population. Higher scores are indicative of better health status. (NCT00498628)
Timeframe: Week 12

Interventionscore on a scale (Least Squares Mean)
Quetiapine51.0
Placebo50.6

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Percent Subjects With no Heavy Drinking Day

Timeline Follow Back data used to calculate the % of subjects that didn't have a heavy drinking day during study weeks 3-11. (NCT00498628)
Timeframe: Study Weeks 3-11

InterventionParticipants (Count of Participants)
Quetiapine Fumerate Plus Medical Management17
Sugar Pill Plus Medical Management24

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Quality of Life SF - 12 - Mental Aggregate Score

The SF-12 will be used to assess overall health status. The SF-12 is a 12-item questionnaire developed in 1994 as a shorter alternative to the SF-36 to reproduce the physical and mental health summary measures with at least 90% accuracy. We calculated the physical and mental component summary scores which were both converted to T-scores (min=0, max=100) normed to the general population such that a T=50 is the average score in the general population. Higher scores are indicative of better health status. (NCT00498628)
Timeframe: Week 12

Interventionscore on a scale (Least Squares Mean)
Quetiapine Fumerate Plus Medical Management51.5
Sugar Pill Plus Medical Management50.7

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Percent Very Heavy Drinking Day

Timeline Follow Back data used to calculate the % of very heavy drinking days per week. Heavy drinking is 10+ drinks per day for females and 12+ drinks per day for males (NCT00498628)
Timeframe: Study Weeks 3-11

Interventionpercentage heavy drinking days (Least Squares Mean)
Quetiapine Fumerate Plus Medical Management16.5
Sugar Pill Plus Medical Management18.8

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Pittsburgh Sleep Quality Score

"The PSQI is a 19-item questionnaire assessing the subject's overall sleep experience in the past 30 days (Buysse et al-1989). The lower the overall score, the better the person sleeps. The tool has an adequate internal reliability, validity and consistency for clinical and community samples of the various populations. Range is (0-21); >6 indicative of poor sleep quality. The PSQI was assessed at study weeks 4,8, and 12. Analyses averaged across these weeks." (NCT00498628)
Timeframe: Weeks 4, 8, 12

Interventionscore (Least Squares Mean)
Quetiapine Fumerate Plus Medical Management4.1
Sugar Pill Plus Medical Management5.1

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Percent Heavy Drinking Days

A heavy drinking day is defined as 5 or more drinks for men and 4 or more drinks for women during a 24 hour period. (NCT00498628)
Timeframe: Weeks 3 - 11

Interventionpercentage of heavy drinking days (Least Squares Mean)
Quetiapine Fumerate Plus Medical Management37.1
Sugar Pill Plus Medical Management37.9

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Percent Days Abstinent

Timeline Follow-back drinking data is used to calculate the % of days abstinent per week during Weeks 3-11 (NCT00498628)
Timeframe: Weeks 3-11

Interventionpercentage of days abstinent (Least Squares Mean)
Quetiapine Fumerate Plus Medical Management49.5
Sugar Pill Plus Medical Management47.1

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Penn Alcohol Craving Score (PACS_

The Penn Alcohol Craving Scale (PACS) is a five-item, self-report measure that includes questions about the frequency, intensity, and duration of craving, the ability to resist drinking, and asks for an overall rating of craving for alcohol for the previous week (Flannery et al., 1999). The summed total score of the 5 items was used in the analysis (min=0, max=30) with higher scores indicative of higher craving for alcohol (a poor outcome). Based on clinical study results, the PACS has been shown to be a reliable and valid measure of alcohol craving and can predict subjects at risk for subsequent relapse. The PACS was assessed at study weeks 4, 6, 8, 10, and 12. Analyses averaged across these weeks. (NCT00498628)
Timeframe: Weeks 4, 6, 8, 10, and 12

Interventionscore on a scale (Mean)
Quetiapine Fumerate Plus Medical Management12.1
Sugar Pill Plus Medical Management12.8

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Montgomery-Asberg Depression Rating Scale (MADRS)

The MADRS is an observer rating scale that has proven to be an efficient and practical measure of depression (Montgomery and Asberg, 1979). The scale was constructed to be sensitive to changes in treatment effects. Its capacity to differentiate between responders and non-responders to antidepressant treatment has been shown to be comparable to the Hamilton Rating Scale for Depression, another established measure of depressive symptomatology, but the MADRS has greater sensitivity to change during the course of a depressive phase. It has exhibited high inter-rater reliability and appears to be oriented more towards psychic as opposed to somatic aspects of depression. The MADRS is the sum of the 10-item in a checklist where items are rated on a scale of 0 to 6 with anchors at 2-point intervals. Scores range from 0 to 60. Higher scores are indicative of greater depressive symptoms (a poor outcome). The MADRS was assessed at weeks 4, 6, 8, 10, and 12. Analyses averaged across these weeks. (NCT00498628)
Timeframe: Weeks 3-11

Interventionscore on a scale (Least Squares Mean)
Quetiapine Fumerate Plus Medical Management2.8
Sugar Pill Plus Medical Management4.1

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Number of Participants Remaining on Metabolic Syndrome at Week 16

Metabolic syndrome is defined as the presence of at least 3 out of the following Adult Treatment Panel III-A (ATP III-A) criteria (all of which are to be assessed at the same visit): waist >102 cm in males, >88 cm in females; blood pressure (BP) systolic BP ≥130 or diastolic BP ≥85 mm Hg; fasting HDL <40 mg/dL in males, <50 mg/dL in females; fasting triglycerides ≥150 mg/dL; fasting glucose ≥100 mg/dL, and/or the start of a treatment for any of the parameters of metabolic syndrome during the course of the study. (NCT00508157)
Timeframe: Week 16

Interventionparticipants (Number)
Control Group22
Aripiprazole16

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Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (HDL) Cholesterol at Week 16

Non-HDL cholesterol was calculated as fasting Total Cholesterol minus fasting HDL Cholesterol. (NCT00508157)
Timeframe: Baseline, Week 16

Interventionpercent change (Mean)
Control Group10.06
Aripiprazole-2.3

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Clinical Global Impression

The score for each subject was the mean rating on the severity item. The score of the item ranged from 1 (normal) to 7 (among most severely ill). (NCT00509067)
Timeframe: Measured at Baseline and Weeks 4, 8, 12, and 16

,
Interventionunits on a scale (Mean)
BaselineWeek 4Week 8Week 12Week 16
Galantamine and CDP-choline Group4.3243.673.873.8
Placebo Group4.383.924.0443.68

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MATRICS Verbal Learning and Memory

The measure of verbal learning and memory is the Hopkins Verbal Learning Test. The score for each subject is the sum of the total number of words recalled correctly for Trials 1, 2, and 3. The measure is the mean of these scores at baseline, Week 8, and Week 16. (NCT00509067)
Timeframe: Measured at Baseline and Weeks 8 and 16

,
Interventionraw scores (Mean)
BaselineWeek 8Week 16
Galantamine and CDP-choline Group20.521.823.0
Placebo Group20.621.220.4

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Negative Symptoms Measured on Positive and Negative Syndrome Scale (PANSS)

The score for each subject was the sum of the ratings for five items on the negative-symptom subscale of the PANSS: 1) blunted affect, 2) emotional withdrawal, 3) poor rapport, 4) passive/apathetic social withdrawal, and 5) lack of spontaneity and flow of conversation. Each item (symptom) is rated on a scale from 1 = absence of negative symptom to 7 = extreme negative symptom. The sum of the ratings for the five items range from 5 to 35, with higher scores indicating more severe symptoms. The primary outcome measure is the mean of the sum of these ratings across subjects. (NCT00509067)
Timeframe: Measured at Baseline and Weeks 4, 8, 12, and 16

,
Interventionunits on a scale (Mean)
BaselineWeek 4Week 8Week 12Week 16
Galantamine/CDP Choline17.6317.0613.9314.9313.93
Placebos for Galantamine/CDP Choline18.2917.0817.2617.3216.05

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DEXA Total Fat

This study hypothesized that antipsychotic treatment would increase total body fat, as measured by whole body dual energy x-ray absorptiometry (DEXA), with larger adverse effects for olanzapine. (NCT00515723)
Timeframe: The relevant time points include baseline, week 6 and week 12.

,,,,
Interventionkilograms of body fat (Mean)
Baseline6 Weeks12 Weeks
Olanzapine32.2434.3835.45
Quetiapine28.8329.6030.10
Risperidone27.6628.2929.23
Total30.2531.0531.52
Ziprasidone31.6031.1830.66

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Clamp Derived Insulin Sensitivity (mg/kg/Min)

This study hypothesized that antipsychotic treatment would decrease insulin sensitivity, with larger adverse effects for olanzapine. Insulin sensitivity describes how sensitive the body is to the effects of insulin. (NCT00515723)
Timeframe: The relevant time points include baseline and week 12.

,,,,
Interventionmg/kg/min (Mean)
BaselineWeek 12
Olanzapine4.393.62
Quetiapine5.285.08
Risperidone5.535.01
Total4.824.50
Ziprasidone4.334.45

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Differences in Scores on the HAM-D (Hamilton Depression Rating Scale)

Hamilton Depression Rating Scale (HAM-D) form lists 21 items, the scoring is based on the first 17. It generally takes 15-20 minutes to complete the interview and score the results. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. (NCT00518973)
Timeframe: Day 1 to LOCF (up to 8 weeks)

InterventionUnits on the scale (Mean)
PlaceboNA
QuetiapineNA

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Difference in Scores on the STAI (State-Trait Anxiety Inventory)

The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety. (NCT00518973)
Timeframe: Day 1 to LOCF (up to 8 weeks)

,
InterventionUnits on the scale (Mean)
TraitState
PlaceboNANA
QuetiapineNANA

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Differences in Scores on the PANNSS (The Positive and Negative Syndrome Scale)

The Positive and Negative Syndrome Scale (PANSS) is a medical scale used for measuring symptom severity of patients with schizophrenia. A clinical interview is conducted and patient is rated from 1 to 7 on 30 different symptoms based on the interview. (NCT00518973)
Timeframe: Day 1 to LOCF (up to 8 weeks)

,
InterventionUnits on the scale (Mean)
Positive ScaleNegative ScaleGeneral Scale
PlaceboNANANA
QuetiapineNANANA

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Hours Occupied by Preoccupations and Rituals Assessed by Yale-Brown-Cornell Eating Disorder Scale (YBC-EDS)

The YBC-EDS is an eight-item scale assessing severity of preoccupations and rituals. (NCT00518973)
Timeframe: Day 1 to LOCF (up to 8 weeks)

,
InterventionHours (Mean)
Hours occupied by preoccupationsHours occupied by rituals
PlaceboNANA
QuetiapineNANA

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Difference in Scores on the EDI-2 (Eating Disorders Inventory)

The EDI consists of 8 subscales measuring drive for thinness, bulimia, body dissatisfaction, ineffectiveness, perfectionism, interpersonal distrust, interoceptive awareness, and maturity fears (NCT00518973)
Timeframe: Day 1 to LOCF (up to 8 weeks)

InterventionUnits on the scale (Mean)
PlaceboNA
QuetiapineNA

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Change in the Quality of Life Questionnaire EQ5D Index From Baseline to End of the Study.

Total possible index score is 0-1(0=The worsen quality of life; 1=The best Quality of life). (NCT00521365)
Timeframe: Baseline and 3 weeks

InterventionScores on a scale (Mean)
Quetiapine 600 mg0.31

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Change in the Clinical Global Impression (CGI) Total Score From Baseline (CGI-S) to Final Visit or Last Observation Carried Forward (LOCF)(CGI-I).

Clinical Global Impression-Severity(CGI-S)is a measurement of illness severity evaluated at baseline. Clinical Global Impression-Improvement(CGI-I)is a measurement of improvement taken at Final Visit (FV) or Last Observation Carried Forward(LOCF).Change CGI Total score is assessed with next equation: CGI-I total score at FV or LOCF - CGI-S score. CGI-S Questionnaire has a scale range 0-7. 0=patients who are not assessed, 1=Normal 7=the most extremely ill patients. CGI-I Questionnaire has a scale range 0-7. 0=patients who are not assessed, 1=Very much improved; 4= No change; 7=Very much worse. (NCT00521365)
Timeframe: Baseline and 3 weeks

InterventionScores on a scale (Mean)
Quetiapine 600 mg-3.95

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Change in the Clinical Global Impression - Improvement (CGI-I) at Final Visit or Last Observation Carried Forward (LOCF).

Change in the CGI- I at Final Visit or Last Observation Carried Forward (LOCF). CGI I Questionnaire has a one item with scale range 0 to 7. 0=patients who ere not assessed, 1=Very much improved; 4= No change; 7=Very much worse. (NCT00521365)
Timeframe: Baseline and 3 weeks

InterventionScores on a scale (Mean)
Quetiapine 600 mg1.67

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Change in the Barnes Akathisia Rating Scale (BARS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF).

Change in the BARS total score from baseline to Final Visit or Last Observation Carried Forward (LOCF). BARS Questionnaire has 4 items with scale range 0 to 3 for 3 items and 0 to 5 for 1 item. 0=Normal; 3 or 5=Most abnormal. Total possible score is 0-14. (NCT00521365)
Timeframe: Baseline and 3 weeks

InterventionScores on a scale (Mean)
Quetiapine 600 mg1.78

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Change in Weight From Baseline to Final Visit or Last Observation Carried Forward (LOCF).

(NCT00521365)
Timeframe: Baseline and 3 weeks

InterventionKg (Mean)
Quetiapine 600 mg0.27

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Change in Waist Circumference From Baseline to Final Visit or Last Observation Carried Forward (LOCF).

(NCT00521365)
Timeframe: Baseline and 3 weeks

Interventioncm (Mean)
Quetiapine 600 mg-0.29

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Number of Participants With Young Mania Rating Scale (YMRS) Response at Final Visit or Last Observation Carried Forward (LOCF)

"Number of participants that had Young Mania Rating Scale (YMRS) response at Final Visit or Last Observation Carried Forward (LOCF). A patient is scored as responder if the change from inclusion shows a reduction of 6 points in the YMRS total score.~YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60." (NCT00521365)
Timeframe: 21 days ± 2 days or Last Observation Carried Forward

InterventionParticipants (Number)
Quetiapine 600 mg81

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Number of Participants With Young Mania Rating Scale (YMRS) Remission at Final Visit or Last Observation Carried Forward (LOCF).

"Number of participants that had Young Mania Rating Scale (YMRS) remission at Final Visit or Last Observation Carried Forward (LOCF). A patient is classified in remission if his/her final YMRS total score was ≤11.~YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60." (NCT00521365)
Timeframe: 21 days ± 2 days or Last Observation Carried Forward

InterventionParticipants (Number)
Quetiapine 600 mg49

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Number of Participants With >7% Increase in Weight

Number of participants with >7% increase in weight from baseline to end of study. (NCT00521365)
Timeframe: Baseline and 3 weeks

InterventionParticipants (Number)
Quetiapine 600 mg1

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Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 3

Change in the YMRS total score from baseline to visit 3(2 weeks). YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0-60. (NCT00521365)
Timeframe: Baseline and 2 weeks

InterventionScores on a scale (Mean)
Quetiapine 600 mg-18.01

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Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 2.

Change in the YMRS total score from baseline to visit 2 (1 week) ,. YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0-60. (NCT00521365)
Timeframe: Baseline and 1 week

InterventionScores on a scale (Mean)
Quetiapine 600 mg-11.5

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Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to End of Treatment (Day 21)

Change in the YMRS total score from baseline to Final Visit or Last Observation Carried Forward (LOCF), modified intention to treat (mITT) population. YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60. (NCT00521365)
Timeframe: Baseline and 3 weeks

InterventionScores on a scale (Mean)
Quetiapine 600 mg-20.72

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Change in the Simpson-Angus Scale (SAS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF).

"Change in the Simpson-Angus Scale (SAS) total score from baseline to Final Visit or Last Observation Carried Forward (LOCF).~SAS Questionnaire has a 6 items with scale range 0 to 3 for each item.0=Normal; 3=Most abnormal. Total possible score is 0-18." (NCT00521365)
Timeframe: Baseline and 3 weeks

InterventionScores on a scale (Mean)
Quetiapine 600 mg1.16

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Change in the Quality of Life Questionnaire EQ5D Visual Analogue Scale (VAS) From Baseline to Final Visit or Last Observation Carried Forward (LOCF).

Change from baseline to Final Visit or Last Observation Carried Forward (LOCF). Quality of Life Questionnaire (EQ5D) part 2 has 1 item with continuous scale range 0 to 100. 0=The worsen Quality of Life; 100=The best Quality of life. (NCT00521365)
Timeframe: Baseline and 3 weeks

InterventionScores on a scale (Mean)
Quetiapine 600 mg27.73

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Least Square Mean Change From Randomization to Week 8 in Hamilton Rating Scale for Anxiety (HAM-A) Total Score

"Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).~Results based on MITT population with available data for this outcome measure. Least square mean of each treatment was adjusted for baseline value." (NCT00534599)
Timeframe: Baseline (randomization) and then 8 weeks

Interventionunits on scale (Least Squares Mean)
Quetiapine XR-10.74
Placebo-9.61

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Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 8

Hamilton Rating Scale for Anxiety (HAM-A) response is derived from the HAM-A total score and is defined as a decrease from baseline total HAM-A score of at least 50%. (1=Yes, 0=No) Results based on MITT population with available data for this outcome measure. (NCT00534599)
Timeframe: Baseline (randomization) and then 8 weeks

InterventionParticipants (Number)
Quetiapine XR84
Placebo72

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Number of Patients With HAM-A Response (≥50% Score Reduction From Randomization) at Week 1

"Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).~Results based on MITT population with available data for this outcome measure." (NCT00534599)
Timeframe: Baseline (randomization) and then 8 weeks

InterventionParticipants (Number)
Quetiapine XR33
Placebo22

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Number of Patients With HAM-A Remission (Total Score ≤7) at Week 8

Hamilton Rating Scale for Anxiety (HAM-A) remission is derived from the HAM-A total score and is defined as a HAM-A total score of ≤7. 1=Yes, 0=No Results based on MITT population with available data for this outcome measure. (NCT00534599)
Timeframe: Baseline (randomization) and then 8 weeks

InterventionParticipants (Number)
Quetiapine XR48
Placebo34

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"Number of Patients With Clinical Global Impression-Global Improvement (CGI-I) Score of Much/Very Much Improved at Week 8"

"This pertains to the CGI-I scale which rates improvement of anxiety on a scale from 1-7, with '1' showing the best improvement(Very Much Improved) and '7' showing the worst improvement (Very Much Worse) as compared to the baseline visit. A rating of '2' indicates 'Much Improved'.~Results based on MITT population with available data for this outcome measure." (NCT00534599)
Timeframe: Baseline (randomization) and then 8 weeks

InterventionParticipants (Number)
Quetiapine XR114
Placebo97

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Least Square Mean Change From Randomization to Week 1 in CGI-S Score

Results based on MITT population with available data for this outcome measure. (NCT00534599)
Timeframe: Baseline (randomization) and then 8 weeks

InterventionLS mean change from randomization (Least Squares Mean)
Quetiapine XR-0.56
Placebo-0.35

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Least Square Mean Change From Randomization to Week 1 in HAM-A Psychic Anxiety Subscale Score

Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).Results based on MITT population with available data for this outcome measure. (NCT00534599)
Timeframe: Baseline (randomization) and then 8 weeks

InterventionLS mean change from randomization (Least Squares Mean)
Quetiapine XR-3.70
Placebo-2.46

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Mean Change From Randomization to Week 8 in Q-LES-Q Item 15 (Satisfaction With Medication) Score

Results based on MITT population with available data for this outcome measure. (NCT00534599)
Timeframe: Baseline (randomization) and then 8 weeks

InterventionMean change from randomization (Mean)
Quetiapine XR0.30
Placebo0.40

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Least Square Mean Change From Randomization to Week 1 in HAM-A Somatic Anxiety Subscale Score

"Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).~Results based on MITT population with available data for this outcome measure." (NCT00534599)
Timeframe: Baseline (randomization) and then 8 weeks

InterventionLS mean change from randomization (Least Squares Mean)
Quetiapine XR-2.74
Placebo-2.0

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Least Square Mean Change From Randomization to Week 8 in Clinical Global Impression-Severity of Illness (CGI-S) Score

"The CGI-S is assessed on a seven-point scale ranging from most extremely ill/very much worse (7) to normal/very much improved (1).~Results based on MITT population with available data for this outcome measure." (NCT00534599)
Timeframe: Baseline (randomization) and then 8 weeks

InterventionLS mean change from randomization (Least Squares Mean)
Quetiapine XR-1.36
Placebo-1.13

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Least Square Mean Change From Randomization to Week 8 in HAM-A Psychic Anxiety Subscale Score

The HAM-A psychic anxiety factor subscale is defined as the sum of the following 7 HAM-A factors: anxious mood, tension, fears, insomnia, intellectual, depressed mood and behavior at the interview (i.e.items 1-6 and 14, respectively) Results based on MITT population with available data for this outcome measure. (NCT00534599)
Timeframe: Baseline (randomization) and then 8 weeks

InterventionLS mean change from randomization (Least Squares Mean)
Quetiapine XR-6.09
Placebo-5.21

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Least Square Mean Change From Randomization to Week 8 in Quality of Life Enjoyment and Satisfaction Questionaire (Q-LES-Q) Percent Maximum Total Score

"The Q-LES-Q score is the sum of the first 14 items, larger values indicating a higher perceived quality of life enjoyment and satisfaction. This total score was converted to a % maximum score using the following scoring conversion: %Maximum score = (Total score-14)*(100/560)rounded to an integer.~Results based on MITT population with available data for this outcome measure." (NCT00534599)
Timeframe: Baseline (randomization) and then 8 weeks

InterventionLS mean change from randomization (Least Squares Mean)
Quetiapine XR7.33
Placebo6.43

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Least Square Mean Change From Randomization to Week 8 in HAM-A Somatic Anxiety Subscale Score

"The HAM-A Somatic cluster subscale is defined as the sum of the following 7 HAM-A items: somatic (muscular), somatic (sensory), cardiovascular symptoms, respiratory symptoms, gastrointestinal symptoms, genitourinary symptoms and autonomic system (i.e. items 7-13 respectively).~Results based on MITT population with available data for this outcome measure." (NCT00534599)
Timeframe: Baseline (randomization) and then 8 weeks

InterventionLS mean change from randomization (Least Squares Mean)
Quetiapine XR-4.63
Placebo-4.38

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Least Square Mean Change From Randomization to Week 1 in HAM-A Total Score

"Hamilton Rating Scale for Anxiety (HAM-A) consists of 14 items to evaluate anxiety. Each item is rated on a scale from 0-4, with '0' showing no anxiety (not present) and '4' showing the worst (very severe).~Results based on MITT population with available data for this outcome measure." (NCT00534599)
Timeframe: Baseline (randomization) and then 8 weeks

InterventionLS mean change from randomization (Least Squares Mean)
Quetiapine XR-6.45
Placebo-4.47

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Mean Change From Randomization to Week 8 in Q-LES-Q Item 16 (Overall Quality of Life) Score

Results based on MITT population with available data for this outcome measure. (NCT00534599)
Timeframe: Baseline (randomization) and then 8 weeks

InterventionMean change from randomization (Mean)
Quetiapine XR0.30
Placebo0.20

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Swanson, Nolan and Pelham IV (SNAP-IV) Oppositional-Defiant Disorder Subscale

The Swanson, Nolan and Pelham (SNAP-IV) is a 90-item, parent-completed questionnaire consisting of symptoms of ADHD, aggression, depression, and mania. Parents rate each item from 0(not at all) to 3 (very much) based on their child's behavior during the past week. The scores from the Oppositional-Defiant Disorder section of this questionnaire will be used as secondary efficacy measures of parent-reported aggressive behavior. These scores range from 0-24. (NCT00550147)
Timeframe: See arm/group - repeated measures analysis

Interventionunits on a scale (Mean)
Baseline19.0
Visit 5 - MPH Monotherapy - Week 414.5
Visit 10 - MPH+Quetiapine - Week 1310.3

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CGI-S: Clinical Global Improvement Scale

"The CGI-S is a 1-7 investigator rating of overall severity of target behavioral symptoms, which will be completed at each visit as a secondary efficacy measure of global behavioral functioning. A score of 1 indicates normal, not ill at all and a score of 7 indicates among the most extremely ill patients." (NCT00550147)
Timeframe: See Arm/Group - Repeated Measures

Interventionunits on a scale (Mean)
Baseline5.3
Visit 5 - MPH Monotherapy - Week 44.1
Visit 10 - MPH + Quetiapine - Week 132.8

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RAAPP: Rating of Aggression Against People and/or Property Scale

The RAAPP is a global rating scale of aggression that is completed by a clinician based on interview and observation data. It is scored from 1 (no aggression reported) to 5 (intolerable behavior). (NCT00550147)
Timeframe: See Arm/Group - Repeated Measures

Interventionunits on a scale (Mean)
Baseline4.3
Visit 5 - MPH Monotherapy - Week 43.2
Visit 10 - MPH+Quetiapine - Week 132.0

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Attention Deficit/Hyperactivity Disorder Rating Scale -IV- Parent Version (ADHDRS-IV-Parent Version)

The Attention Deficit/Hyperactivity Disorder Rating Scale -IV- Parent Version (ADHDRS-IV-Parent:Inv) (Faries, Yalcin, Harder, & Heiligenstein, 2001) is an interviewer-administered semi structured interview with the parent, focusing on the 18 DSM-IV symptoms. Ratings are made on a 0 (never or rarely) to 3 (very often) scale. The range of the ADHDRS-IV is 0-54. A zero (0) scores indicates no ADHD symptoms and 54 indicates most severe ADHD symptoms. The ADHDRS-IV-Parent:Inv provides an overall severity score, symptom count, and ADHD diagnosis for the child. (NCT00550147)
Timeframe: See Arm/Group - repeated measures

Interventionunits on a scale (Mean)
Baseline45.7
Visit 5 - MPH Monotherapy - Week 432.7
Visit 10 - MPH+Quetiapine - Week 1319.4

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Modified Overt Aggression Scale (MOAS)

"The Modified Overt Aggression Scale (MOAS) is a clinician-rated scale of aggressive outbursts experienced in the past week. Weightings are assigned for severity and frequency of aggression. MOAS total severity score will be completed as a secondary efficacy measure of aggressive behavior. The range for the MOAS is 0-235. A score of 0 indicates no aggression and a score of 235 indicates the most severe and frequent aggressive outbursts." (NCT00550147)
Timeframe: See arm/group - repeated measures

Interventionunits on a scale (Mean)
Baseline229.0
Visit 5 - MPH Monotherapy - Week 473.7
Visit 10 - MPH + Quetiapine - Week 1326.3

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Drinks Per Day

Change in self-reported drinks/day (drinks consumed divided by the number of days during that study period). (NCT00550394)
Timeframe: baseline to 12 weeks or endpoint (up to 11 weeks)

InterventionDrinks per day (Mean)
Quetiapine + Placebo-1.4
Quetiapine + Topiramate-2.4

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Drinks Per Drinking Day

Change in drinks/drinking day (number of drinks consumed divided by the number of days during which alcohol was consumed during that study period) (NCT00550394)
Timeframe: baseline to 12 weeks or endpoint (up to 11 weeks)

InterventionDrinks per drinking day (Mean)
Quetiapine and Placebo-7.2
Quetiapine and Topiramate-7.3

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Percent Heavy Drinking Days

Change in percent heavy drinking days (number of days of > 4 drinks/day divided by number of days in that study period). (NCT00550394)
Timeframe: baseline to 12 weeks or endpoint (up to 11 weeks)

InterventionPercent heavy drinking days (Mean)
Quetiapine and Placebo-10
Quetiapine and Topiramate-14

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Percentage of Days Abstinent

Change in percent days abstinent (the number of non-drinking days divided by the number of days in that study period). (NCT00550394)
Timeframe: baseline to 12 weeks or endpoint (up to 11 weeks)

InterventionPercentage of days abstinent (Mean)
Quetiapine and Placebo15
Quetiapine and Topiramate14

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Change From Baseline on Sheehan- Suicidality Tracking Scale S-STS (2008 Version With 8 Items)

"Sheehan - Suicidality Tracking Scale S-STS (2008 version with 8 items) measures severity of a range of suicidality symptoms. Range of scores: 0-32. A higher score represents more severe suicidality. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA) in which baseline and each of the 8 weekly assessments were the within subject factors (time) and treatment group (treatment) was the between-subjects factor with 3 levels. Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANCOVA. Outcome results with a minus score indicate that patients did better, i.e. had a reduction in symptoms on this scale.." (NCT00579280)
Timeframe: 8 weeks

Interventionscore on a scale (Mean)
Quetiapine SR-.95
Divalproex Sodium ER-.07
Placebo-.3

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Change From Baseline in Hamilton Anxiety Scale (HAM-A) Scores

"Hamilton Anxiety Scale (HAM-A) measures severity of anxiety symptoms - range of scores is 0-56. A higher score means worse anxiety. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA) in which baseline and each of the 8 weekly assessments were the within subject factors (labeled time) and treatment group (labeled treatment) was the between-subjects factor with 3 levels. The focus was on the treatment-by-time effect showing whether the trajectory of response differed over time by treatment group. Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANCOVA. Outcome results with a minus score indicate that patients did better, i.e. had a reduction in symptoms on this scale." (NCT00579280)
Timeframe: 8 weeks

Interventionscore on a scale (Least Squares Mean)
Quetiapine SR-11.7
Divalproex Sodium ER-6.4
Placebo-8.4

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Change From Baseline on Patient Global Improvement Scale (PGI-21) for Anxiety Symptoms

"The PGI-21 Anxiety is a 21-point patient-rated global improvement for anxiety symptoms. Response range: -10 to +10. The higher the score the more improvement. At Baseline all patients have a score of 0 (zero), against which any subsequent improvements or deterioration is assessed. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA). The focus was on the treatment-by-time effect showing whether the trajectory of response differed over time by treatment group. Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANOVA. Outcomes showing scores above zero indicate that patients did better, i.e. showed improvement on this scale." (NCT00579280)
Timeframe: 8 weeks

Interventionscore on a scale (Least Squares Mean)
Quetiapine SR3.9
Divalproex Sodium ER1.9
Placebo2.3

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Change From Baseline on Montgomery Asberg Depression Rating Scale (MADRS)

"Montgomery Asberg Depression Rating Scale (MADRS) measures severity of depressive symptoms. Range of scores: 0-60. A higher score shows greater severity of depressive symptoms. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA) in which baseline and each of the 8 weekly assessments were the within subject factors (time) and treatment group (treatment) was the between-subjects factor with 3 levels. The central focus was on the treatment-by-time effect showing whether the trajectory of response differed over time by treatment group. Also, group differences in baseline-to-endpoint changes in efficacy were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANCOVA. Outcome results with a minus score indicate that patients did better, i.e had a reduction in symptoms on this scale." (NCT00579280)
Timeframe: 8 weeks

Interventionscore on a scale (Least Squares Mean)
Quetiapine SR-11.5
Divalproex Sodium ER-5.5
Placebo-7.3

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Change From Baseline on Sheehan Disability Scale (SDS) - Total

"Sheehan Disability Scale (SDS) measures severity of functional impairment or disability. There are 4 scores: 1) Work Disability 2) Social Disability 3) Family Life Disability. Each of these domains is scored 0-10, with a higher score representing greater disability or functional impairment. These 3 domain scores are added to give a Total Disability scale score. Range of response for Total Disability: 0 to 30. A higher score shows greater disability/functional impairment. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA). Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANCOVA. Outcome results with a minus score indicate that patients did better, i.e. had a reduction in symptoms on this scale." (NCT00579280)
Timeframe: 8 weeks

Interventionscore on a scale (Least Squares Mean)
Quetiapine SR-6.5
Divalproex Sodium ER-3
Placebo-5.3

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Change From Baseline on Clinician Global Impression Scale for Bipolar Disorder (CGI-BP) (Overall Severity)

"Clinician Global Impression Scale for Bipolar Disorder (CGI-BP) measures the severity of bipolar disorder symptoms overall. Range of response: i1. normal, not ill to 7. very severely ill. A higher score represents greater severity. A last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA) in which baseline and each of the 8 weekly assessments were the within subject factors (time) and treatment group (treatment) was the between-subjects factor with 3 levels was used. The focus was on the treatment-by-time effect and whether the trajectory of response differed over time by treatment. Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANCOVA. Outcome results with a minus score indicate that patients did better, i.e. had a reduction in symptoms on this scale." (NCT00579280)
Timeframe: 8 weeks

Interventionscore on a scale (Least Squares Mean)
Quetiapine SR-1.2
Divalproex Sodium ER-.5
Placebo-1.0

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Change From Baseline on Rapid Ideas Scale (RISc)

"Rapid ideas Scale (RISc) measures severity of rapid thoughts. Range of scores is 0-100. A higher score means more severe rapidity of thinking. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA) in which baseline and each of the 8 weekly assessments were the within subject factors (time) and treatment group (treatment) was the between-subjects factor with 3 levels. The focus was on the treatment-by-time effect showing whether the trajectory of response differed over time by treatment group. Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANCOVA. Outcome results with a minus score indicate that patients did better, i.e. had a reduction in symptoms on this scale." (NCT00579280)
Timeframe: 8 weeks

Interventionscore on a scale (Mean)
Quetiapine SR-28.9
Divalproex Sodium ER-19.7
Placebo-23.1

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Change From Baseline in Young Mania Rating Scale (YMRS)

"Young Mania Rating Scale (YMRS) measures severity of mania / hypomania symptoms. Range of scores: 0-60. A higher score shows worse mania / hypomania. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA) in which baseline and each of the 8 weekly assessments were the within subject factors (time) and treatment group (treatment) was the between-subjects factor with 3 levels. The focus was on the treatment-by-time effect showing whether the trajectory of response differed over time by treatment group. Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANCOVA. Outcome results with a minus score indicate that patients did better, i.e. had a reduction in symptoms on this scale." (NCT00579280)
Timeframe: 8 weeks

Interventionscore on a scale (Least Squares Mean)
Quetiapine SR-5.4
Divalproex Sodium ER-4.4
Placebo-4.3

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Change From Baseline in the CGI-21 Anxiety

"The CGI-21 Anxiety is a 21-point clinician-rated global improvement for anxiety symptoms. Response range: -10 to +10. The higher the score the more improvement. At Baseline all patients have a score of 0 (zero), against which any subsequent improvements or deterioration is assessed. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA). The focus was on the treatment-by-time effect showing whether the trajectory of response differed over time by treatment group. Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANOVA. Outcomes showing scores above zero indicate that patients did better, i.e. showed improvement on this scale." (NCT00579280)
Timeframe: 8 weeks (using LOCF Repeated Measures ANOVA)

Interventionscore on a scale (Least Squares Mean)
Quetiapine SR4.9
Divalproex Sodium ER2.9
Placebo3.4

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Change From Baseline in Sheehan Panic Disorder Scale (SPS)

"Sheehan Panic Disorder Scale (SPS). Range of scores: 0-140. Higher scores indicate greater severity of symptoms. The relative efficacy of quetiapine SR vs. divalproex ER and placebo was tested using a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA) in which baseline and each of the 8 weekly assessments for the efficacy variables were the within subject factors (time) and treatment group (treatment) was the between-subjects factor with 3 levels. The focus in this analysis was on the treatment-by-time effect showing whether the trajectory of response differed over time by treatment group. Also, group differences in baseline-to-endpoint changes in efficacy measures were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the baseline-to-endpoint LOCF ANCOVA. Outcome results with a minus indicate that patients did better, i.e. had a reduction in symptoms on this scale." (NCT00579280)
Timeframe: 8 weeks

Interventionscore on a scale (Least Squares Mean)
Quetiapine SR-24.4
Divalproex Sodium ER-14.8
Placebo-18.3

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Change From Baseline in Sheehan Irritability Scale (SIS)

"Sheehan Irritability Scale (SIS) measures severity of anxiety symptoms. Range of scores: 0-70. A higher score shows worse irritability. The relative efficacy of the 3 treatments was tested with a last-observation-carried forward (LOCF) repeated-measures analysis of variance (ANOVA) in which baseline and each of the 8 weekly assessments were the within subject factors (time) and treatment group (treatment) was the between-subjects factor with 3 levels. The focus was on the treatment-by-time effect showing whether the trajectory of response differed over time by treatment group. Also, group differences in baseline-to-endpoint changes in the efficacy measure were tested using LOCF ANCOVA followed by pairwise planned comparisons (t-tests). The least square means shown here are from the LOCF baseline-to-endpoint ANCOVA. Outcome results with a minus score indicate that patients did better, i.e. had a reduction in symptoms on this scale." (NCT00579280)
Timeframe: 8 weeks

Interventionscore on a scale (Least Squares Mean)
Quetiapine SR-29.8
Divalproex Sodium ER-22.6
Placebo-19.4

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The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Extra-pyramidal Events at Month 12 in the Safety Population

Extra-pyramidal events include tremor, hypokinesia, muscle rigidity, hyperkinesia, and extrapyramidal disorder. (NCT00600756)
Timeframe: 12 months

InterventionEvents (Number)
Quetiapine XR51
Risperidone112

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The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants at Month 12 in the Safety Population With Individual Symptoms Assessed by the Modified UKU: Hyperprolactinaemia in Women

Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). Hyperprolactinaemia in women is defined as number of women who show the individual adverse event (AE) hyperprolactinaemia. An individual AE Hyperprolactinaemia is defined as an AE with a worse degree of hyperprolactinaemia compared with baseline and with a possible or probable relationship to study drug. (NCT00600756)
Timeframe: Month 12

InterventionParticipants (Number)
Quetiapine XR0
Risperidone10

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The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants at Month 12 in the Safety Population With Individual Symptoms Assessed by the Modified UKU: Sexual Dysfunction in Men

Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). Sexual dysfunction in men is defined as number of men who show the individual adverse event (AE) sexual dysfunction. An individual AE sexual dysfunction is defined as an AE with a worse degree of sexual dysfunction compared with baseline and with a possible or probable relationship to study drug. (NCT00600756)
Timeframe: Month 12

InterventionParticipants (Number)
Quetiapine XR9
Risperidone13

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The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Discontinued the Study Because of an TEAE at Month 12 in the Safety Population

Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day). (NCT00600756)
Timeframe: 12 months

InterventionParticipants (Number)
Quetiapine XR57
Risperidone48

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The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Had at Least 1 Cardiac TEAE at Month 12 in the Safety Population

Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day). (NCT00600756)
Timeframe: 12 months

InterventionParticipants (Number)
Quetiapine XR22
Risperidone17

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The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants Who Had at Least 1 Extra-pyramidal TEAE at Month 12 in the Safety Population

Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day). (NCT00600756)
Timeframe: 12 months

InterventionParticipants (Number)
Quetiapine XR38
Risperidone83

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The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Number of Participants With a Treatment-emergent Adverse Event (TEAEs) at Month 12 in the Safety Population

Treatment-emergent adverse events are defined as adverse events that occurred after the first intake of the study medication (or on the same day). (NCT00600756)
Timeframe: 12 months

InterventionParticipants (Number)
Quetiapine XR238
Risperidone258

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The Safety and Tolerability of Quetiapine XR vs Risperidone by Evaluating the Number of Participants at Month 12 in Safety Population With Individual Symptoms Assessed by the Modified Udvalg for Kliniske Undersogelser, Side Effect Rating Scale: Neurologic

Symptoms are graded according to degree (not present to severe) and causal relationship (improbable, possible, probable). An individual AE is defined as an AE with a worse degree compared with Baseline and with a possible or probable relationship to study drug. (NCT00600756)
Timeframe: 12 months

InterventionParticipants (Number)
Quetiapine XR4
Risperidone20

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To Evaluate the Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population Regarding Health Economics Outcomes by Evaluating the Functional Improvement Rate of the Modified Vocational Status Index/ Location Code Index: Stable State

Stable State was defined as having the same status in occupational and residential status as at Baseline. (NCT00600756)
Timeframe: 12 months

InterventionParticipants with stable state (Number)
Quetiapine XR160
Risperidone171

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Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Intent-to-Treat (ITT) Population

The SWN-K is comprised of 20 questions, each of which is rated using a 6-point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20 to 120, with higher scores implying higher subjective well-being. (NCT00600756)
Timeframe: Baseline and Month 12

InterventionScores on a scale (Least Squares Mean)
Quetiapine XR22.7
Risperidone19.4

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Change From Baseline in Mean Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Total Score at Month 12 in the Per Protocol Population

The SWN-K is comprised of 20 questions, each of which is rated using a 6-point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20 to 120, with higher scores implying higher subjective well-being. (NCT00600756)
Timeframe: Baseline and Month 12

InterventionScores on a scale (Least Squares Mean)
Quetiapine XR23.2
Risperidone21.1

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Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Emotional Regulation at Month 12 in the ITT Population.

The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24. (NCT00600756)
Timeframe: Baseline and 12 months

InterventionScores on a scale (Least Squares Mean)
Quetiapine XR4.5
Risperidone3.9

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Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Mental Functioning at Month 12 in the ITT Population.

The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24. (NCT00600756)
Timeframe: Baseline and 12 months

InterventionScores on a scale (Least Squares Mean)
Quetiapine XR4.9
Risperidone3.9

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Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Physical Functioning at Month 12 in the ITT Population.

The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24. (NCT00600756)
Timeframe: Baseline and 12 months

InterventionScores on a scale (Least Squares Mean)
Quetiapine XR4.9
Risperidone4.0

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Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Self-control at Month 12 in the ITT Population.

The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24. (NCT00600756)
Timeframe: Baseline and 12 months

InterventionScores on a scale (Least Squares Mean)
Quetiapine XR4.1
Risperidone3.8

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Change From Baseline in the Subjective Well-Being Under Neuroleptic Treatment Scale (SWN-K) Subscale Score: Social Integration at Month 12 in the ITT Population.

The SWN-K total score is the sum of 5 subscores (4 questions each): physical functioning, social integration, mental functioning, self-control, and emotional regulation. The subscores are rated using a 6-point scale (the higher the grade, the better the response). Possible subscores range from 4 to 24. (NCT00600756)
Timeframe: Baseline and 12 months

InterventionScores on a scale (Least Squares Mean)
Quetiapine XR4.6
Risperidone4.0

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Number of Participants Using Antidepressants at Month 12 in the ITT Population

"The number of participants who were taking at least 1 antidepressant at Month 12. Antidepressants are all concomitant medications classified in the Anatomical Therapeutic Chemical(ATC)Subgroup N06-Antidepressants." (NCT00600756)
Timeframe: 12 months

InterventionParticipants (Number)
Quetiapine XR72
Risperidone63

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Number of Subjects Who Had an Unscheduled Visits Due to Worsening of Schizophrenia, Dose Change, or Adverse Event at Month 12 in the ITT Population

Unscheduled visits due to worsening of schizophrenia, dose change or adverse event including the hospitalizations due to psychiatric disorders during the study (i.e. from Visit 1 to Termination date + 30 days) in inpatients units, in emergency wards and in day clinics. (NCT00600756)
Timeframe: Month 12

InterventionParticipants (Number)
Quetiapine XR94
Risperidone70

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Responder Rate at Month 6 in the Per Protocol Population Using the Subjective Well-being Under Neuroleptics Scale, Short Version (SWN-K) Total Score

The SWN-K is comprised of 20 questions, rated on a 6-point scale from 1 (not at all) to 6 (very much). Scores range from 20 to 120, with higher scores implying higher subjective well-being. A responder is defined as a subject with an increase of 10 points or 20% from baseline in SWN-K total score (non-inferiority limit of -9.7% in responder rate) (NCT00600756)
Timeframe: 6 months

InterventionParticipants (Number)
Quetiapine XR136
Risperidone158

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The Compliance of Patients Taking Quetiapine XR Versus Risperidone at Month 12 by Evaluating the Number of Participants Who Returned Study Drug at Month 12 in the ITT Population

(NCT00600756)
Timeframe: 12 months

InterventionParticipants (Number)
Quetiapine XR270
Risperidone249

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The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in CGI-SCH Overall Severity Score

For the CGI-SCH (Clinical Global Impression-Schizophrenia severity of illness scale) overall severity of illness, the score ranged from 1 (normal, not ill) to 7 (among the most severely ill). Change from baseline in CGI-SCH score was divided into 3 classes: worsening (change score>0), stable (change score=0) and improved (change score<0). (NCT00600756)
Timeframe: 12 months

InterventionScores on a scale (Mean)
Quetiapine XR3.8
Risperidone3.9

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The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in CGI-SCH Overall Severity Score (Improved).

For the CGI-SCH overall severity of illness, the score ranged from 1 (normal, not ill) to 7 (among the most severely ill). CGI-SCH score was divided into 3 classes: worsening (change score>0), stable (change score=0) and improved (change score<0). Change from baseline in CGI-SCH overall severity of illness in number of participants with CGI-SCH overall severity score improvement. (NCT00600756)
Timeframe: 12 months

InterventionParticipants (Number)
Quetiapine XR176
Risperidone178

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The Effect of Quetiapine XR Versus Risperidone at Month 12 in the ITT Population on Core Schizophrenic and Depressive Symptoms by Evaluating the Change From Baseline in the Calgary Depression Scale for Schizophrenia (CDSS) Total Score

The CDSS total score is the sum of 9 questions and ranges from 0 to 27. The higher the score, the more severe are the symptoms. (NCT00600756)
Timeframe: 12 months

InterventionScores on a scale (Least Squares Mean)
Quetiapine XR-4.7
Risperidone-3.7

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The Effect of Quetiapine XR Versus Risperidone by Evaluating the Relapse Rate at Month 12 in the ITT Population

Relapse is defined as at least one increase of greater than or equal to 2 points on the CGI-SCH overall severity score during the treatment period or at least one hospitalization due to psychiatric disorders during the treatment period. (NCT00600756)
Timeframe: 12 months

InterventionParticipants (Number)
Quetiapine XR43
Risperidone31

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The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Mean Number of Lost School/Work Days at Month 12 in the ITT Population

"Workers and students are defined from the modified vocational status index excluding subjects Retired or Unemployed, whether or not expected to work." (NCT00600756)
Timeframe: 12 months

InterventionDays (Mean)
Quetiapine XR10
Risperidone6.7

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The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Number of Participants Using Other Psychotropic Medications at Month 12 in the ITT Population

Other psychotropic medications include antiepileptics, anti-parkinson drugs, antipsychotics, and antidepressants. (NCT00600756)
Timeframe: 12 months

InterventionParticipants (Number)
Quetiapine XR138
Risperidone141

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The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Participants With at Least 1 Hospitalization Due to Psychiatric Disorders at Month 12 in the ITT Population

All hospitalizations due to psychiatric disorders during the study (i.e. from Visit 1 to Termination date + 30 days) in inpatients units, in emergency wards, and in day clinics. (NCT00600756)
Timeframe: 12 months

InterventionParticipants (Number)
Quetiapine XR37
Risperidone21

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The Effect of Quetiapine XR Versus Risperidone Regarding Health Economics Outcomes by Evaluating the Time Between First Study Drug Intake and First Hospitalization for Patients With 1 Hospitalization in the ITT Population

(NCT00600756)
Timeframe: 12 months

InterventionDays (Mean)
Quetiapine XR144.3
Risperidone152.8

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The Remission Rate in Both the Quetiapine XR Group and the Risperidone Group at Month 12 in the ITT Population

Remission was defined as a SWN-K total score greater than or equal to 80. The reported population is participants who showed remission over, time from baseline to Month 12 (NCT00600756)
Timeframe: 12 months

InterventionParticipants (Number)
Quetiapine XR139
Risperidone128

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The Safety and Tolerability of Quetiapine XR Versus Risperidone by Evaluating the Mean Change From Baseline to Month 12 in Prolactin Levels in the Safety Population

The normal range for men is 0 to 14, and for women is 0 to 24. (NCT00600756)
Timeframe: 12 months

Interventionng/mL (Mean)
Quetiapine XR-7.735
Risperidone15.990

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Adequate Relief in Pain Score During Treatment

"Biweekly relief in pain Biweekly subjects were asked whether they had adequate relief of pain. It was binary questionnaire i.e.- Did you have adequate relief of pain in last two weeks? 1) yes 2) no The measure is percentage of subjects who said yes who had adequate relief of pain." (NCT00617396)
Timeframe: 8 weeks

Interventionpercentage of subjects (Number)
Quetiapine ( 50mg/Day -100mg/Day)52.6

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Change in Scores in Measurements of Depressive Symptoms (Hamilton Depression Rating Scale, HAM-D), Generalized Anxiety Symptoms (Hamilton Anxiety Rating Scale, HAM-A) and the Sleep Quality Item of the Pittsburgh Sleep Quality Index (PSQI).

Subjects scores on secondary efficacy measures were measured, comparing baseline and the end of 8 weeks of treatment, including the Hamilton Depression Rating Scale, HAM-D, which has 21 items, with scores ranging from 0-66; the Hamilton Anxiety Rating Scale, HAM-A, which has 14 items, with scores ranging from 0-56; and the sleep quality item of the PSQI, a four-point scale rating sleep quality as very good, fairly good, fairly bad or very bad. (NCT00619892)
Timeframe: Comparing baseline and the end of 8 weeks of treatment

,
Interventionunits on a scale (Mean)
Decrease in HAM-D scoresDecrease in HAM-A scoresIncrease in PSQI sleep quality scores
Placebo3.85.51.3
Quetiapine XR5.06.81.3

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Change in Mean Total Panic Disorder Severity Scale (PDSS) Scores

Possible total scores on the PDSS range from 0-28. The outcome measure represents the change, between baseline and the end of 8 weeks of treatment, in the the total PDSS scores. Lower scores indicate less severe panic disorder symptoms. A negative mean change in the scores at the end of 8 weeks represents a decrease in severity of panic disorder symptoms. (NCT00619892)
Timeframe: Baseline and the end of 8 weeks of treatment

Interventionunits on a scale (Mean)
Quetiapine SR-5.3
Placebo-5.6

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Percentage of Participants Attaining Abstinence for Three Weeks

Abstinence was defined as a negative urine drug screen (UDS) (for cocaine) for three consecutive weeks of the trial measure at either time point Week 6 or Week 12 (NCT00631748)
Timeframe: Abstinence defined as negative UDS for 3 consecutive weeks of the trial

InterventionPercentage of Participants (Number)
Study Drug45.5
Placebo44.4

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Timeline Followback Interview (TLFB)

The primary outcome measure was the self-report of cocaine use in the past week, as assessed with a Timeline Followback Interview (TLFB). The TLFB is a questionnaire in which the subject is asked to self-report how much cocaine was used and how much money was spent on cocaine every day for the past 1-2 weeks. (NCT00631748)
Timeframe: Grams of cocaine used at end of study (12-weeks)

Interventiongrams of cocaine used (Mean)
Study Drug0.11
Placebo0.63

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Change From Baseline to Week 12 of PANSS Score

30-item scale where each symptom is rated on a severity ranging from 1-7. Symptoms are categorized into 7 items referring to positive, 7 items referring to negative and 16 general psychotic. Total score range 30- 210, higher values represent worse outcome. Number of participants analyzed refers to valid for efficacy per protocol population. (NCT00640562)
Timeframe: 12 weeks from baseline to last visit

Interventionscore on scale (Mean)
Seroquel XR102.26
Risperidone100.51

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Change From Screening Visit to Week 12 of Prolactin Live

Plasma prolactin live was drawn prior to morning meal at the screening visit at the last visit (NCT00640562)
Timeframe: 12 week from screening visit to last visit

InterventionKG (Least Squares Mean)
Seroquel XR61.20
Risperidone90.80

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Concomitant Use of Antidepressive Drugs From Baseline to Week 12

Number of concomitant users of antidepressive drugs during the study; the number of participants analyzed refers to ITT/safety population, that is to overall participants excluding the 6 participants who did not assume any study drug administration (NCT00640562)
Timeframe: Change of drug use from baseline to last visi

InterventionParticipants (Number)
Seroquel XR14
Risperidone17

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Concomitant Use of Antidepressive Drugs From Baseline to Week 12

Number of concomitant users of antidepressive drugs during the study; the number of participants analyzed refers to safety population, that is to overall participants excluding 6 participants who did not assume any study drug administration (NCT00640562)
Timeframe: 12 week from baseline to last visi

InterventionParticipants (Number)
Seroquel XR12
Risperidone11

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Change From Baseline to Week 12 of HAM-D Score

21-item scale for depression. Symptoms are rated finely (on a 5-point scale: absent; doubtful or trivial; mild: moderate severe) or coarsely (on a 3- point scale: absent; doubtful or mild; obvious, distinct, or severe).Total score range 0- 66, higher values represent worse outcome.Number of participants refers to valid for efficacy per protocol. Change:total score at week 12 minus total score at baseline. (NCT00640562)
Timeframe: 12 weeks from baseline to last visit

InterventionScore on scale (Mean)
Seroquel XR-29.83
Risperidone-23.02

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- Change From Baseline to Week 12 of Clinical Global Impression (CGI- Severity of Illness) Score

"The CGI-S subset ranges from 1 to 7 such that a score of 1 indicates normal, not at all ill, while a score of 7 indicates among the most extremely ill of patients. The change from start of treatment (baseline V2) in the Severity of Illness will be calculated by subtracting the score at start of treatment (baseline V2) from the following visits" (NCT00640562)
Timeframe: 12 weeks from baseline to last visit

InterventionScore on scale (Least Squares Mean)
Seroquel XR-1.50
Risperidone-1.04

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Body Mass Index (BMI) at Week 12

Patient weight and height have been be collected in order to assess the Body Mass Index (BMI). The mean BMI values reported are assessed after 12 weeks of treatment. (NCT00640562)
Timeframe: 12 week

InterventionKg/m^2 (Mean)
Seroquel XR29.07
Risperidone28.80

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CGI- Global Improvement Mean Score at Week 12

"The CGI-S subset ranges from 1 to 7 such that a score of 1 indicates normal, not at all ill, while a score of 7 indicates among the most extremely ill of patients. The change from start of treatment (baseline V2) in the Severity of Illness will be calculated by subtracting the score at start of treatment (baseline V2) from the following visits" (NCT00640562)
Timeframe: 12week: descriptive statistic of CGI by visit and treatment

Interventionscore on a scale (Mean)
Seroquel XR91
Risperidone88

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Change From Baseline in the Simpson Angus Scale (SAS) Total Score to Week 12 as an Indication of Neurological Side Effects Section

"Extrapyramidal Side Effects (EPS) will be assessed using the Simpson-Angus Scale (SAS; Simpson GN et al 1970) . The CRF is source data for these assessments and day 0 is considered as baseline.~The SAS scale, containing 10 items, will be rated on a five-point scale where 0 is normal and 4 are severe symptoms. Min score =0, max score 40~Change from start of treatment (day 0) will be calculated as the visit score minus the score at start of treatment for each of the neurological assessments." (NCT00640562)
Timeframe: 12 weeks from baseline to last visit

Interventionscore on scale (Mean)
Seroquel XR2.74
Risperidone3.88

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Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score.

"The CDSS scale is used to assess the level of depression in schizophrenia and to estimate the severity of depressive symptoms.~CDSS has 9 items rated on four-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Anchor point descriptions are provided to aid differentiation between each item score. The first eight items are rated on basis of patients' responses to questions; the 9 item is based on clinician's assessment.~The sum score is derived by adding the point score of all items (from 0 to 27 points); total score 4-5 is considered for minor depression and 6-7 score for major depression." (NCT00640562)
Timeframe: 12 week from baseline to last visit

InterventionScore on a scale (Least Squares Mean)
Seroquel XR7.31
Risperidone5.53

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Change From Baseline to Week 12 of Drug Attitude Inventory 10 Item Scale (DAI 10) Score

These items are presented as self-report statements with which the patient agrees or disagrees. Each response is scored as +1 if correct or -1 if incorrect. The final score is the grand total of the positive and negative points. A positive score means a positive subjective response. A negative total score means a negative subjective response (NCT00640562)
Timeframe: 12 week from baseline to last visit

Interventionscore on scale (Least Squares Mean)
Seroquel XR86.38
Risperidone76.64

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Change in Social and Occupational Functioning Assessment Scale (SOFAS)

Change in SOFAS score. The SOFAS is a 100 point single item scale that rates functioning of a patient. The scale values range from 1=most impaired to 100=healthiest individual. The scale also includes a rating point of 0=missing information. (NCT00640601)
Timeframe: Baseline to 24 weeks

Interventionunits on a scale (Mean)
Seroquel XR6.45

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Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Negative Scale Score

Change in negative subscale of PANSS. This subscale calculates the sum of the scores in PANSS items N1-N7. (1=absent symptoms, 7=extreme symptoms). Maximum total score: 49, minimum total score: 7. (NCT00640601)
Timeframe: Baseline to 24 weeks

Interventionunits on a scale (Mean)
Seroquel XR3.67

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Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Positive Scale Score

Change in positive subscale of PANSS. This subscale calculates the sum of the scores in PANSS items P1-P7. (1=absent symptoms, 7=extreme symptoms). Maximum total score: 49, minimum total score: 7. (NCT00640601)
Timeframe: Baseline to 24 weeks

Interventionunits on a scale (Mean)
Seroquel XR2.36

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Change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score

Change in PANSS total score which includes Positive, Negative and General psychopathology. The PANSS is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7, where 1=absent, 7=extreme). Maximum total score: 210, minimum total score is 30. Seven items are referring to positive symptoms (P1-7), seven items to negative symptoms (N1-7) and 16 items to general psychopathology (G1-16). The assessment prior to start of treatment is considered the baseline assessment. (NCT00640601)
Timeframe: Baseline to 24 weeks

Interventionunits on a scale (Mean)
Seroquel XR10.95

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Change in Clinical Global Impression-Improvement (CGI-I) Scale

Change in CGI-I scale. This scale is the second part of the CGI scale that is scored at Visit 3 to week 24 to observe the patient's change from start of treatment. The scores for the CGI-I subset ranges from 1 to 7 (1=very much improved, 7=very much worse and a score of 4 indicates no change.) (NCT00640601)
Timeframe: Day 7 - week 24

Interventionunits on a scale (Mean)
Seroquel XR0.55

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Percentage of Subjects With Improved Clinical Benefit From Assessment of Clinical Global Impression-Clinical Benefit (CGI-CB) Scale From Baseline to Week 24 or End of Study

Proportional change in CGI-CB score The CGI-CB scale is used to evaluate investigator's global weighted impression of efficacy and interference of adverse events (AEs) from enrolment to every visit. The score ranges from 1 to 10. The lower the score the better the outcome, e.g.: a score of 1 means that there is marked therapeutic effect with no burden of AEs. A score of 10 signifies that the burden of AEs outweighs the therapeutic effect, or no therapeutic effect with high burden of AEs. A change score for each subject will be calculated by subtracting the baseline score from the visit score. (NCT00640601)
Timeframe: Baseline to 24 weeks (or end of study)

InterventionPercentage of Participants (Mean)
Seroquel XR56.88

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Change in Barnes Akathisia Rating Scale (BARS)

The Percentage of patients with change in BARS score was calculated. The BARS is a 4 item scale that is rating Extrapyramidal symptoms (EPS) on a 4-point scale for the first three questions and on a 6-point scale for the last question. 0=normal and a higher value represents more pronounced symptoms of EPS. BARS has a focus on the akathisia symptoms of EPS. (NCT00640601)
Timeframe: Baseline to 24 weeks

Interventionpercentage of subjects (Number)
ImprovedUnchangedWorsened
Seroquel XR28.163.78.2

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Change in Safety Measure: Simpson-Angus Scale (SAS)

The Percentage of patients with change in Simpson-Angus Scale (SAS)was calculated. This is a 10 item scale that is rated on a five-point scale where 0=normal and 4=severe symptoms of Extrapyramidal symptoms (EPS) with a focus on parkinsonian symptoms of EPS. (NCT00640601)
Timeframe: Baseline to 24 weeks

InterventionPercentage of subjects (Number)
ImprovedUnchangedWorsened
Seroquel XR46.143.510.4

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Change in Global Assessment Scale (GAS)

Change in GAS score. The GAS is a 100-point single item scale that rates patient's functioning on a hypothetical continuum of mental health to mental illness. The scale values range from 1 to 100 (1=most impaired, 100=healthiest). (NCT00640601)
Timeframe: Baseline to 24 weeks

Interventionunits on a scale (Mean)
Seroquel XR5.54

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Change in Clinical Global Impression-Severity (CGI-S) Scale

The CGI-S assesses severity of illness which is scored to rate the patient's current clinical state at start of treatment. The scores range from 1 to 7, where 1= normal, not at all ill, while a score of 7=among the most extremely ill of subjects. The change from start of treatment in the severity of illness is calculated by subtracting the score at start of treatment from the visit score. Alleviation of symptom severity will be indicated by a negative change score. (NCT00640601)
Timeframe: Baseline to 24 weeks

Interventionunits on a scale (Mean)
Seroquel XR0.51

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Change in Clinical Global Impression-Clinical Benefit (CGI-CB) Score

Numerical change in CGI-CB score. The CGI-CB scale is used to evaluate investigator's global weighted impression of efficacy and interference of adverse events (AEs) from enrolment to every visit. The score ranges from 1 to 10. The lower the score the better the outcome, e.g.: a score of 1 means that there is marked therapeutic effect with no burden of AEs. A score of 10 signifies that the burden of AEs outweighs the therapeutic effect, or no therapeutic effect with high burden of AEs. A change score for each subject will be calculated by subtracting the baseline score from the visit score. (NCT00640601)
Timeframe: Baseline to 24 weeks

Interventionunits on a scale (Mean)
Seroquel XR1.41

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Percentage of Slow Wave Sleep

The primary variable is the change of percentage of slow wave sleep (SWS) from baseline to the 28th day (LOCF). (NCT00642369)
Timeframe: 28 days

,
Interventionpercentage of slow wave sleep (Mean)
percentage at baselinepercentage on the 28th daypercentage change from baseline to the 28th day
Haloperidol8.66.3-2.3
Quetiapine Fumarate10.59.2-1.4

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Percentage of Rapid Eye Movement Sleep

The primary variable is the change of the percentage of rapid eye movement (REM)sleep from baseline to the 28th day (LOCF). (NCT00642369)
Timeframe: 28 days

,
Interventionpercentage of rapid eye movement sleep (Mean)
percentage at baselinepercentage on the 28th daypercentage change from baseline to the 28th day
Haloperidol13.210.4-2.7
Quetiapine Fumarate12.616.43.9

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Change in Clinical Global Impressions of Improvement or Severity (CGI-I or S) Score

"The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment.~1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill." (NCT00671853)
Timeframe: Week 0 - Week 8

Interventionunits on a scale (Mean)
Quetiapine XR-1.10
Placebo for Quetiapine XR-0.8

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Change in Hamilton Rating Scale for Anxiety (HAM-A)

The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe (NCT00671853)
Timeframe: Week 0 - Week 8

Interventionunits on a scale (Mean)
Quetiapine XR-9.54
Placebo for Quetiapine XR-8.25

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Change in the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Score

This assessment degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning. The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70 with a higher score indicating less enjoyment and satisfaction. (NCT00671853)
Timeframe: Week 0 - Week 8

Interventionunits on a scale (Mean)
Quetiapine XR0.11
Placebo for Quetiapine XR-0.06

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Change in the 17 Item Hamilton Rating Scale for Depression (HAM-D-17) Score

A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression. (NCT00671853)
Timeframe: Week 0 - Week 8

Interventionunits on a scale (Mean)
Quetiapine XR-9.91
Placebo for Quetiapine XR-7.41

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Response Rate (≥ 50% Improvement) on Hamilton Rating Scale for Depression (HAM-D-17)

A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression. (NCT00671853)
Timeframe: Week 0 - Week 8

Interventionparticipants (Number)
Quetiapine XR12
Placebo for Quetiapine XR11

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Remission Rate (≤ 7) on Hamilton Rating Scale for Depression (HAM-D-17)

A score of 0-7 is considered to be normal. Hamilton Rating Scale total score ranges from 0-57 where higher scores are indicative of more depression. Remission is defined by the number of participants with Hamilton Rating Scale for Depression score equal to or less than 7. (NCT00671853)
Timeframe: Week 0 - Week 8

InterventionParticipants (Number)
Quetiapine XR6
Placebo for Quetiapine XR6

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Change From Baseline in the Young Mania Rating Scale (YMRS) Item 4 Score to Each Assessment

The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 4 (sleep) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. (NCT00672490)
Timeframe: Baseline and 4 weeks

Interventionscore on a scale (Mean)
Quetiapine Fumarate Used as Mono-Therapy-2.0
Quetiapine Fumarate Used as Adjunct Therapy-2.1

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Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 28)

The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania). (NCT00672490)
Timeframe: Baseline and 4 weeks

Interventionscore on a scale (Mean)
Quetiapine Fumarate Used as Mono-Therapy-25.7
Quetiapine Fumarate Used as Adjunct Therapy-26.1

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Remission Rate (Number of Patients With Clinically Significant Remission)

"The number of patients with clinically significant remission (defined as YMRS total score ≤12) at Day 28 was calculated.~The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania. Total score ≤12 indicates remission." (NCT00672490)
Timeframe: From Baseline to 4 weeks

InterventionParticipants (Number)
Quetiapine Fumarate Used as Mono-Therapy117
Quetiapine Fumarate Used as Adjunct Therapy123

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Response Rate (Number of Patients With Clinically Response)

The number of patients with clinically response (defined as ≥50% reduction in the YMRS total score from baseline to Day 28) was calculated. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or 50% reduction) from baseline indicates a reduction (or improvement) in manic symptoms. (NCT00672490)
Timeframe: From Baseline to 4 weeks

InterventionParticipants (Number)
Quetiapine Fumarate Used as Mono-Therapy139
Quetiapine Fumarate Used as Adjunct Therapy153

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Change From Baseline in the Clinical Global Impressions for Bipolar Disorder Severity of Illness (CGI-BP-S) Score to Each Assessment (Day 28)

The CGI-BP-S scale rates the severity of the patient's illness at the time of assessment and is scored from 1 to 7 (1=normal, not ill to 7=very severely ill). Higher CGI-BP-S scores indicate greater illness severity (NCT00672490)
Timeframe: Baseline and 4 weeks

Interventionscore on a scale (Mean)
Quetiapine Fumarate Used as Mono-Therapy-2.65
Quetiapine Fumarate Used as Adjunct Therapy-0.17

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Treatment of Agitation (Change From Baseline in the PANSS Activation Subscale Score to Day 28)

The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS activation subscale score for effect on agitation and aggression is the sum of 6 PANSS individual items (ie, hostility, poor impulse control, excitement, uncooperativeness, poor rapport and tension) and ranges from 6 to 42. (NCT00672490)
Timeframe: Baseline and 4 weeks

Interventionscore on a scale (Mean)
Quetiapine Fumarate Used as Mono-Therapy-5.4
Quetiapine Fumarate Used as Adjunct Therapy-5.8

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Treatment of Aggression Risk (Change From Baseline in the PANSS Supplement Aggression Risk Subscale Score to Day 28)

"The PANSS Supplemental Aggression Risk subscale score is the sum of 3 standard PANSS items - Excitement, Hostility and Depression - and 3 supplemental PANSS items related to anger - Anger, Difficulty in Delaying Gratification and Affective Lability and ranges from 6 to 42, where 6 is the best and 42 the worst score for the combined scale." (NCT00672490)
Timeframe: Baseline and 4 weeks

Interventionscore on a scale (Mean)
Quetiapine Fumarate Used as Mono-Therapy-6.8
Quetiapine Fumarate Used as Adjunct Therapy-7.3

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Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score to Each Assessment(Day 28)

The MADRS is a 10-item scale that evaluates depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. Higher MADRS scores indicate higher levels of depressive symptoms. The MADRS total score is the sum of all 10 individual-item scores and ranges from 0 to 60. (NCT00672490)
Timeframe: Baseline and 4 weeks

Interventionscore on a scale (Mean)
Quetiapine Fumarate Used as Mono-Therapy-2.99
Quetiapine Fumarate Used as Adjunct Therapy-3.02

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Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score to Each Assessment (Day 28)

The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 individual-item scores and ranges from 30 to 210 (NCT00672490)
Timeframe: Baseline and 4 weeks

Interventionunits on a scale (Mean)
Quetiapine Fumarate Used as Mono-Therapy-16.12
Quetiapine Fumarate Used as Adjunct Therapy-16.44

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TimeLine Follow Back (TLFB) to Measure Percent Heavy Drinking Days During the Medication/Placebo Phase

The total number of heavy drinking days per Arm was divided by total number of days, multiplied by 100%, to report the percent days of heavy drinking per Arm. (NCT00674765)
Timeframe: 12 weeks

Interventionpercent days of heavy drinking (Number)
Seroquel (Quetiapine)20
Placebo Sugar Pill24

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The Change in the Hamilton Rating Scale for Depression (HAM-D)

HAM-D is a 17-21 item observer-rated scale to assess presence and severity of depressive states. 9 items are scored 0-4, whereas the further 8 are scored 0-2, as these represent variables which do not lend themselves to quantitative rating (0=absent; 1=doubtful or slislight; 2=clearly present). Higher scores indicate higer depressive state (NCT00681668)
Timeframe: Baseline Day 1 to final visit 28 weeks

Interventionscores on a HAM-D scale (Mean)
Quetiapine Fumarate21

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Measure of Relapse: Change in Puffs Chosen Between Baseline and Relapse Phase

"This is a measure of marijuana self-administration and relapse since each initial puff costs $10 and is a burden to overcome just to smoke.~Over each 3 day period, the puffs chosen by each participant is averaged for a single value." (NCT00743366)
Timeframe: Days 1-3 (Baseline) and Days 6-8 (Relapse Phase)

InterventionPuffs (Mean)
Quetiapine, Marijuana2.5
Placebo, Marijuana1.5

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Brief Assessment of Cognition for Affective Disorders (BAC-A)

This is a series of neurocognitive tests and includes brief assessments of attention, motor speed, working memory, verbal memory, reasoning and problem solving, verbal fluency, affective interference, and emotion inhibition. The total BAC-A score is represented by a composite T-score which is dimensionless. This is computed by adding up the scores for each trial of a test domain (e.g. verbal memory) within the cognitive battery. Each test domain total is then inputted into a proprietary BAC-A calculator which determines the composite T-scores. A higher score indicates better performance. A study of 404 healthy adults demonstrated a mean composite score of 50 with a standard deviation of 10 (Keefe et al. Schizophrenia Bulletin. 2008; 102: 108-115). (NCT00746421)
Timeframe: 6 weeks

Interventionunits on a scale (composite t-score) (Mean)
Quetiapine XR Group49.6
Placebo Group47.8

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The Continuous Performance Test-Identical Pairs Version

The Continuous Performance Test, Identical Pairs version (CPT-IP) is a cognitive test that requires a subject to respond whenever two identical stimuli appear in a row within a sequence of 150 rapidly flashed trials. The outcome is measured as d' (detection signal) and is dimensionless. Among healthy adult men and women, d' scores ranged from 3.07-4.57 (Chen et al. Schizophrenia Bulletin, 1998; 24(1):163-174). The higher the value the better the performance. The d' is calculated by averaging the d' scores from three trials. (NCT00746421)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Quetiapine XR Group2.5
Placebo Group2.8

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The Change in Positive and Negative Syndrome Scale(PANSS)Total Score

"PANSS, a 30-item scale where each symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme), total score is 30 - 210.~Description of the reporting Groups: Evaluate the efficacy of Quetiapine XR with daily dose 400 mg - 800 mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline to Day 57 in total score of PANSS using the last observation carried forward (LOCF) method" (NCT00779506)
Timeframe: From baseline to Day 57

Interventionscore on a scale (Mean)
Quetiapine XR-26.8

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Positive and Negative Syndrome Scale (PANSS) Positive Score

To evaluate the change of positive symptoms from baseline to Day 57 in PANSS positive score, a 7-item scale where eash symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme) (NCT00779506)
Timeframe: From baseline to Day 57

Interventionscore on a scale (Mean)
Quetiapine XR-7.4

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Positive and Negative Syndrome Scale (PANSS) Negative Score

To evaluate the change of negative symptoms from baseline to Day 57 in PANSS negative score, a 7-item scale where each symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme) (NCT00779506)
Timeframe: From baseline to Day 57

Interventionscore on a scale (Mean)
Quetiapine XR-6.2

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Positive and Negative Syndrome Scale (PANSS) General Psychopathology Score

To evaluate the change of general psychopathology symptoms from baseline to Day 57 in PANSS general score, a 16-item scale where each symptom is rated on a severity scale ranging from 1 (absent) to - 7 (extreme) (NCT00779506)
Timeframe: From baseline to Day 57

Interventionscore on a scale (Mean)
Quetiapine XR-13.2

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Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

To treat depressive symptoms in acute schizophrenic patients by evaluation of the change from baseline to day 67 in MADRS total score, a 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0-6 scale, higher MADRS scores indicate higher levels of depressive symptoms. (NCT00779506)
Timeframe: From baseline to Day 57

Interventionscore on a scale (Mean)
Quetiapine XR-9.44

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Global Assessment of Functioning (GAF) Score

To improve functional capability in acute schizophrenic patients by evaluation of the change from baseline to Day 57 in GAF scale score, a single-item rating scale for evaluating the overall functioning on a continuum from psychologic or psychiatric sickness to health. (NCT00779506)
Timeframe: From baseline to Day 57

Interventionscore on a scale (Mean)
Quetiapine XR17.9

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Clinical Global Impression (CGI) Score

The Clinical Global Impression - Severity (CGI-S) and - illness (CGI-I) is used in this study. The CGI-S is scored to rate the patient's current clinical state. The CGI-I is scored to rate the patient's change from baseline CGI. Each CGI item is scored on a scale from 1 to 7 (CGI-S: 1 = Normal, not ill, 7= Among the most extremely ill patients/ CGI-I: 1= very much improved, 7= very much worse). CGI-I scores greater than 4 indicate worsening, while scores less than 4 indicate improvement (NCT00779506)
Timeframe: From baseline to Day 57

Interventionscore on a scale (Mean)
Quetiapine XR-1.46

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Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Positive and Negative Syndrome Scale (PANSS)

The PANSS is an interview-based measure of psychopathology severity in adults with psychotic disorders. Thirty items are rated using a Likert scale, from 1 - 7. The PANSS total score is the sum of thirty items ranging from 30 to 210 (higher score representing a worsening in psychosis). (NCT00789698)
Timeframe: Baseline and 12 months

Interventionunits on a scale (Least Squares Mean)
Lurasidone-Lurasidone-34.6
Quetiapine-Quetiapine-25.7

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Change From the Acute Phase Baseline to Month 6 of the Double-blind Treatment in the CogState Computerized Cognitive Scores.

The battery has seven outcome measures that measure the cognitive constructs. The seven domains are: detection, identification, one back task, international shopping list task, one card learning task, Groton maze learning task and social emotional matching. The standardized scores for each subject at each assessment will then be averaged to yield a composite score. There are no maximum or minimum values, however a higher score indicates improved performance on the cognitive constructs. The change score is change from baseline to month 6. (NCT00789698)
Timeframe: Baseline and 6 Months

Interventionunits on a scale (Least Squares Mean)
Lurasidone-Lurasidone0.22
Quetiapine-Quetiapine-0.03

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Change From the Acute Phase Baseline to the End (Month 12) of the Double-blind Treatment in the Clinical Global Impression Severity Scale (CGI-S) Scores

The CGI-S is a clinician-rated assessment of the subject's current illness state on a scale ranging from 1-7, where a higher score is associated with greater illness severity. (NCT00789698)
Timeframe: Baseline and 12 months

Interventionunits on a scale (Least Squares Mean)
Lurasidone-Lurasidone-1.9
Quetiapine-Quetiapine-1.6

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Relapse of Psychotic Symptoms

"Time to relapse will be defined as the earliest occurrence of any of the following:~Worsening of >= 30% positive and negative syndrome scale total score from NCT00790192 and clinical global impression-severity sub-scale >=3~rehospitalization for worsening of psychosis~emergence of suicidal ideation, homicidal ideation and/or risk of harm to self or others Comparison of time to relapse of psychotic symptoms between lurasidone and quetiapine XR after 1 year as analyzed using the Cox proportional hazard model with country as a covariate." (NCT00789698)
Timeframe: 12 Months

Interventionparticipants (Number)
Lurasidone-Lurasidone29
Quetiapine-Quetiapine21

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Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, All Patients

Response rate at end of study measured as number of patients with Montgomery Asberg Depression Rating Scale (MADRS) with total score reduction ≥ 50% compared to baseline, the higher number of patients the better (NCT00789854)
Timeframe: 6 week of treatments

InterventionParticipants (Number)
Quetiapine XR Mono114
Add-on Quetiapine XR120
Add-on Lithium102

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Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, All Patients

The physician has evaluated the therapeutic effect and the side effect combined at end of study. Patients with a 'marked/moderate' therapeutic effect and 'None/Do Not Significantly Interfere' side effect has been added. The higher values show more patients with a treatment effect without any side-effect. The range is from 0 patients to the maximum number of patients in the treatment arm (225, 229 or 221). (NCT00789854)
Timeframe: 6 weeks of treatment

InterventionParticipants (Number)
Quetiapine XR Mono135
Add-on Quetiapine XR146
Add-on Lithium131

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Change in Anxiety Measured by STAI, Trait Anxiety Inventory

Self-rating assessment of anxiety measured by State-Trait Anxiety Inventory (STAI), trait anxiety inventory (Scale 20-80, where a lower value shows a larger improvement) (NCT00789854)
Timeframe: 6 weeks of treatment

InterventionScores on a scale (Least Squares Mean)
Quetiapine XR Mono-1.01
Add-on Quetiapine XR-1.36
Add-on Lithium-1.39

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Change in Anxiety Measured by State-Trait Anxiety Inventory (STAI), State Anxiety Inventory

Self-rating assessment of anxiety measured by STAI, state anxiety inventory (Scale 20-80, where a lower value shows a larger improvement) (NCT00789854)
Timeframe: 6 weeks of treatment

InterventionScores on a scale (Least Squares Mean)
Quetiapine XR Mono-0.62
Add-on Quetiapine XR0.014
Add-on Lithium-0.87

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Change in Anxiety Measured by Visual Analog Scale (VAS)

Self-rating assessment of anxiety using a visual analogue scale (VAS). Scale from 0-100, where a lower value shows a larger improvement. (NCT00789854)
Timeframe: 6 weeks of treatment

Interventionscores on a scale (Least Squares Mean)
Quetiapine XR Mono-21.2
Add-on Quetiapine XR-23.4
Add-on Lithium-20.6

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Change in Beck Depression Inventory (BDI)

Self-rating assessment of depressive symptoms using Beck Depression Inventory (BDI). Scale from 0-63, where a lower value shows a larger improvement. (NCT00789854)
Timeframe: 6 weeks of treatment

Interventionscores on a scale (Least Squares Mean)
Quetiapine XR Mono-11.7
Add-on Quetiapine XR-13.5
Add-on Lithium-12.2

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Change in Clinical Global Impression Scale (CGI-S), All Patients

Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale form 1-7, where a lower value shows a larger improvement. (NCT00789854)
Timeframe: 6 weeks of treatment

Interventionscores on a scale (Least Squares Mean)
Quetiapine XR Mono-1.43
Add-on Quetiapine XR-1.65
Add-on Lithium-1.49

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Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Modified Intention to Treat Analysis Set)

Change in LS mean total Montgomery Asberg Depression Rating Scale (MADRS) score from randomisation to end-of-treatment (week 6) (Scale 0-60), lower score indicates a better health status. (NCT00789854)
Timeframe: 6 weeks of treatment

Interventionscores on a scale (Least Squares Mean)
Quetiapine XR Mono-13.9
Add-on Quetiapine XR-15.1
Add-on Lithium-13.3

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Change in Depressive Symptoms Between Randomisation and Week 6 Measured by Change in Montgomery Asberg Depression Rating Scale (MADRS) Total Score (Per Protocol Analysis Set)

Change in LS mean total Montgomery Asberg Depression Rating Scale (MADRS) score from randomisation to end-of-treatment (week 6) (Scale 0-60), lower score indicates a better health status. (NCT00789854)
Timeframe: 6 weeks treatment

Interventionscores on a scale (Least Squares Mean)
Quetiapine XR Mono-16.2
Add-on Quetiapine XR-17.2
Add-on Lithium-14.9

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Change in Pain, Measured by Visual Analog Scale (VAS)

Self-rating assessment of pain using a visual analogue scale (VAS). Scale from 0-100, where a lower value shows a larger improvement. (NCT00789854)
Timeframe: 6 weeks of treatment

Interventionscores on a scale (Least Squares Mean)
Quetiapine XR Mono-9.47
Add-on Quetiapine XR-8.03
Add-on Lithium-8.3

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Change in Quality of Life Measured by Health Questionnaire EQ-5D as Utility

Self rating assessment of quality in life using EQ-5D utility (Scale 0-100, where a higher value shows a larger improvement) (NCT00789854)
Timeframe: 6 weeks of treatment

InterventionScores on a scale (Least Squares Mean)
Quetiapine XR Mono0.184
Add-on Quetiapine XR0.224
Add-on Lithium0.208

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Change in Quality of Life Measured by Short-form Health Survey (SF-36), Mental Component

Self rating assessment of quality in life using SF-36, mental component (Scale 0-100, where a higher value shows a larger improvement) (NCT00789854)
Timeframe: 6 weeks of treatment

InterventionScores on a scale (Least Squares Mean)
Quetiapine XR Mono9.59
Add-on Quetiapine XR10.77
Add-on Lithium9.66

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Change in Quality of Life Measured by Short-form Health Survey (SF-36), Physical Component

Self rating assessment of quality in life using SF-36, physical component (Scale 0-100, where a higher value shows a larger improvement) (NCT00789854)
Timeframe: 6 weeks of treatment

InterventionScores on a scale (Least Squares Mean)
Quetiapine XR Mono5.224
Add-on Quetiapine XR5.065
Add-on Lithium4.566

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Change in Sleep Quality Measured by Montgomery Asberg Depression Rating Scale (MADRS), Item 4

Sleeping quality measured by Montgomery-Asberg Depression Rating Scale (MADRS) item 4 (reduced sleep) (Scale 0-6, where a lower value shows a larger improvement) (NCT00789854)
Timeframe: 6 weeks of treatment

InterventionMADRS item 4 score (Least Squares Mean)
Quetiapine XR Mono-2.2
Add-on Quetiapine XR-2.4
Add-on Lithium-1.63

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Change in Sleep Quality Measured by Pittsburgh Sleep Quality Index (PSQI)

Self-rated sleeping quality measured by PSQI (Scale 0-21, subscales 0-3, 18 questions, where a lower value shows a larger improvement) (NCT00789854)
Timeframe: 6 weeks of treatment

InterventionScores on a scale (Least Squares Mean)
Quetiapine XR Mono-4.77
Add-on Quetiapine XR-4.96
Add-on Lithium-3.51

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Change in Work Productivity and Activity Impairment: General Health (WPAI:GH)

Self rating assessment of working productivity using WPAI:GH (Scale 0 to number of hours worked during a week multiplied with the salary in Euro, a lower value shows a larger improvement) (NCT00789854)
Timeframe: 6 weeks of treatment

InterventionScores on a scale (Least Squares Mean)
Quetiapine XR Mono-233
Add-on Quetiapine XR-185
Add-on Lithium-299

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Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤12

Number of patients in remission with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤12. MADRS scale has range from 0 to 60, where the lower score indicates the better health status. (NCT00789854)
Timeframe: 6 weeks of treatment

InterventionParticipants (Number)
Quetiapine XR Mono67
Add-on Quetiapine XR89
Add-on Lithium73

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Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤8

Number of patients in remission with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤8. MADRS scale has range from 0 to 60, where the lower score indicates the better health status. (NCT00789854)
Timeframe: 6 weeks of treatment

InterventionParticipants (Number)
Quetiapine XR Mono35
Add-on Quetiapine XR58
Add-on Lithium45

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Depression Remission; Montgomery-Asberg Depression Rating Scale MADRS ≤10, All Patients

Number of patients in remission, with total Montgomery Asberg Depression Rating Scale (MADRS) score ≤10. MADRS scale has range from 0 to 60, where the lower score indicates the better health status. (NCT00789854)
Timeframe: 6 weeks of treatment

InterventionParticipants (Number)
Quetiapine XR Mono53
Add-on Quetiapine XR73
Add-on Lithium60

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Responder: Clinical Global Impression Improvement (CGI-I) Item 2, All Patients

Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where lower value shows a larger improvement. (NCT00789854)
Timeframe: 6 weeks of treatment

Interventionscores on a scale (Mean)
Quetiapine XR Mono-1.54
Add-on Quetiapine XR-1.85
Add-on Lithium-1.58

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Secondary Outcome: CGI-S From Baseline to the End of the Double-blind Treatment

Clinical Global Impression of Severity is a clinician-rated assessment of the subject's current illness state on a 7 point scale, where a higher score is associated with greater illness severity. The scale has a single item measured on a 7 point scale from 1 ('normal', not ill) to 7 (extremely ill). (NCT00790192)
Timeframe: 6-Weeks

Interventionscores on a scale (Least Squares Mean)
Lurasidone 80 mg-1.5
Lurasidone 160 mg-1.7
Quetiapine XR 600mg-1.7
Placebo-0.9

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Primary Efficacy Endpoint: Mean Change in Total PANSS Score From Baseline to the End of the Double Blind Phase

The PANSS (Positive and Negative Syndrome Scale) is a 30-item scale (range 30-210) designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items. Higher scores indicate worsening. (NCT00790192)
Timeframe: Week 6

Interventionscores on a scale (Least Squares Mean)
Lurasidone 80 mg-22.2
Lurasidone 160 mg-26.5
Quetiapine XR 600mg-27.8
Placebo-10.3

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Triglyceride Levels

(NCT00806234)
Timeframe: Change from baseline to 24 weeks

Interventionmg/dL (Least Squares Mean)
Healthy Lifestyle Information0.2
Switch Treatment + Healthy Lifestyle Instruction16.6
Metformin Treatment + Healthy Lifestyle Instruction14.7

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Body Mass Index (BMI) Z-score Change

(NCT00806234)
Timeframe: Change from baseline to 24 weeks

InterventionZ Score (Least Squares Mean)
Healthy Lifestyle Information0.040
Switch Treatment + Healthy Lifestyle Instruction-0.112
Metformin Treatment + Healthy Lifestyle Instruction-0.088

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Change in Low Density Lipoprotein (LDL) Cholesterol Level

(NCT00806234)
Timeframe: From Baseline to Week 24

Interventionmg/dL (Least Squares Mean)
Healthy Lifestyle Information3.6
Switch Treatment + Healthy Lifestyle Instruction-8.1
Metformin Treatment + Healthy Lifestyle Instruction-4.1

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Change in Whole Body Insulin Sensitivity Index

(NCT00806234)
Timeframe: Change from baseline to 24 weeks

InterventionmU/L (Least Squares Mean)
Healthy Lifestyle Information0.74
Switch Treatment + Healthy Lifestyle Instruction0.42
Metformin Treatment + Healthy Lifestyle Instruction-0.34

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The Number of Patients With the Response, Where Response is Defined as ≥50% Reduction From Baseline to Final Assessment (Day 57) in CDRS-R Total Score

The number of patients reaching response from Days 8 to 57 was calculated. The CDRS-R is a 17-item scale with 3 items scored from 1-5 and 14 items scored from 1-7, where higher scores indicating more severe depression. The 17 item scores are summed to give the total score (total score range 17-113). (NCT00811473)
Timeframe: Days 8 to 57

Interventionparticipants (Number)
Quetiapine XR58
Placebo55

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The Proportion of Patients at Final Assessment (Day 57) With Improvement of Overall Bipolar Illness

"The proportion of patients with improvement of overall bipolar illness at Day 57 was calculated. Improvement defined as a CGI-BP-C of Much or Very much improved in overall bipolar illness assessment." (NCT00811473)
Timeframe: Day 57

InterventionProportions (Number)
Quetiapine XR0.522
Placebo0.40

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Change From Baseline to Final Assessment (Day 57) in the CGI-BP-S

The CGI-BP-S scale rates the severity of the patient's illness at the time of assessment and is scored from 1 to 7 (1=normal, not ill to 7=very severely ill). Higher CGI-BP-S scores indicate greater illness severity. (NCT00811473)
Timeframe: Change from Baseline to Day 57

InterventionScores on a Scale (Least Squares Mean)
Quetiapine XR-17.2
Placebo-1.35

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Number of Patients Reaching Remission Where Remission is Defined as CDRS-R Total Score ≤28 at Final Assessment (Day 57).

The number of patients with remission from Days 8 to 57 was calculated. The CDRS-R is a 17-item scale with 3 items scored from 1-5 and 14 items scored from 1-7, where higher scores indicating more severe depression. The 17 item scores are summed to give the total score (total score range 17-113). (NCT00811473)
Timeframe: Days 8 to 57

Interventionparticipants (Number)
Quetiapine XR42
Placebo34

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Change in the Children Depression Rating Scale, Revised (CDRS-R) Total Score From Baseline to Final Assessment (Day 57)

Severity of depression in children and adolescents was calculated based on the 17-item CDRS-R scale (3 items scored from 1-5 and 14 items scored from 1-7, with higher scores indicating more severe depression). The 17 item scores are summed to give the total score (total score range 17-113). (NCT00811473)
Timeframe: Will be scored at all visits. the analysis is the change from baseline to the final assessment at day 57

InterventionScores on a scale (Least Squares Mean)
Quetiapine XR-29.6
Placebo-27.3

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CGI-BP-C Score at Final Assessment (Day 57)

The CGI-BP-C scale rates how much the patient's illness has improved or worsened compared to the phase immediately preceding treatment and is scored on a scale from 1 to 8 (1=very much improved to 7=very much worse; 8=not applicable). CGI-BP-C scores >4 indicate worsening, while scores <4 indicate improvement. (NCT00811473)
Timeframe: Change from Baseline to day 57

InterventionScores on a scale (Least Squares Mean)
Quetiapine XR2.4
Placebo2.6

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Clinical Global Impression - Severity of Illness (CGI-S) Score

Clinical Global Impression - Severity of Illness. Maximum possible value is 7 (worst outcome), the minimum is 1 (best outcome). Values are considered better outcome: decrease from baseline > 1 score. (NCT00852631)
Timeframe: Day 14

InterventionScores on a scale (Mean)
Seroquel XR3.2

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Change in Clinical Global Impression - Severity of Illness (CGI-S) Score

Clinical Global Impression - Severity of Illness. Maximum possible value is 7 (worst outcome), the minimum is 1 (best outcome). Values are considered better outcome: decrease from baseline > 1 score. (NCT00852631)
Timeframe: From Day 1 (Baseline) to Day 42

InterventionScores on a scale (Mean)
Day 1 (Baseline) (n= 28)Day 42 (n= 17)
Seroquel XR4.62.7

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Change in Positive and Negative Syndrome Scale (PANSS) Total Score

"Change in Positive and Negative Syndrome Scale Total Score from Day 1 (baseline) to Day 42 (final visit) or withdrawal. Minimum value of total PANSS is 30 , Maximum is 210.~Minimum value considered better is score decreased from baseline at least 30%." (NCT00852631)
Timeframe: From Day 1 (baseline) to Day 42

InterventionScores on a scale (Mean)
Day 1 (Baseline) (n= 28)Day 42 (n= 17)
Seroquel XR85.348.5

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The Mean Change From Baseline to Week 8 in the Hamilton Anxiety Rating Scale (HARS) Total Score

HARS assesses severity of anxiety symptoms. It ranges from a minimum of 0 to a maximum of 56 (higher scores indicating a greater severity of anxiety symptoms) (NCT00857584)
Timeframe: baseline, week 8

Interventionscore on a scale (Mean)
Quetiapine Extended Release-13.1
Setraline-10.6

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The Mean Change From Baseline to Week 8 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score

MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms) (NCT00857584)
Timeframe: baseline. week 8

Interventionscore on a scale (Mean)
Quetiapine Extended Release-19.4
Setraline-18.2

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Number of Patients Response at Week 1

"Number of patients responded to the treatment at week 1, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 1.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms." (NCT00857584)
Timeframe: week 1

InterventionParticipants (Number)
Quetiapine Extended Release4
Setraline4

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Number of Patients With Remission at Week 1.

"Number of patients who achieved remission at week 1, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms." (NCT00857584)
Timeframe: week 1

InterventionParticipants (Number)
Quetiapine Extended Release6
Setraline5

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Number of Patients With Remission at Week 2.

"Number of patients who achieved remission at week 2, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms." (NCT00857584)
Timeframe: week 2

InterventionParticipants (Number)
Quetiapine Extended Release6
Setraline5

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Number of Patients With Remission at Week 4.

"Number of patients who achieved remission at week 4, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms." (NCT00857584)
Timeframe: week 4

InterventionParticipants (Number)
Quetiapine Extended Release3
Setraline3

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Number of Patients With Remission at Week 8.

"Number of patients who achieved remission at week 8, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms." (NCT00857584)
Timeframe: week 8

InterventionParticipants (Number)
Quetiapine Extended Release3
Setraline4

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Number of Patients With Response at Week 2

"Number of patients responded to the treatment at week 2, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 2.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms." (NCT00857584)
Timeframe: week 2

InterventionParticipants (Number)
Quetiapine Extended Release8
Setraline2

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Number of Patients With Response at Week 4.

"Number of patients responded to the treatment at week 4, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 4.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms." (NCT00857584)
Timeframe: week 4

InterventionParticipants (Number)
Quetiapine Extended Release8
Setraline6

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Number of Patients With Response at Week 8.

"Number of patients responded to the treatment at week 8, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 8.~MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms." (NCT00857584)
Timeframe: week 8

InterventionParticipants (Number)
Quetiapine Extended Release8
Setraline5

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The Mean Change From Baseline to Week 1 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score

CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity) (NCT00857584)
Timeframe: baseline, week 1

Interventionscore on a scale (Mean)
Quetiapine Extended Release-0.79
Setraline-1.08

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The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score

MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms) (NCT00857584)
Timeframe: baseline, week 2

Interventionscore on a scale (Mean)
Quetiapine Extended Release-13.1
Setraline-6.6

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The Mean Change From Baseline to Week 1 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score

MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms) (NCT00857584)
Timeframe: baseline, week 1

Interventionscore on a scale (Mean)
Quetiapine Extended Release-9.5
Setraline-8.6

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The Mean Change From Baseline to Week 2 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score

CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity) (NCT00857584)
Timeframe: baseline, week 2

Interventionscore on a scale (Mean)
Quetiapine Extended Release-1.36
Setraline-1.00

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The Mean Change From Baseline to Week 4 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score

CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity) (NCT00857584)
Timeframe: baseline, week 4

Interventionscore on a scale (Mean)
Quetiapine Extended Release-2.09
Setraline-2.56

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The Mean Change From Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HARS) Total Score

HARS assesses severity of anxiety symptoms. It ranges from a minimum of 0 to a maximum of 56 (higher scores indicating a greater severity of anxiety symptoms) (NCT00857584)
Timeframe: baseline, week 4

Interventionscore on a scale (Mean)
Quetiapine Extended Release-13.4
Setraline-8.9

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The Mean Change From Baseline to Week 4 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score

MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms) (NCT00857584)
Timeframe: baseline, week 4

Interventionscore on a scale (Mean)
Quetiapine Extended Release-16.1
Setraline-17.7

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The Mean Change From Baseline to Week 8 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score

CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 (higher scores indicating a greater clinical severity) (NCT00857584)
Timeframe: baseline, week 8

Interventionscore on a scale (Mean)
Quetiapine Extended Release-2.9
Setraline-2.88

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Mean Baseline Fasting Non-HDL Levels

(NCT00857818)
Timeframe: At baseline (Day 1)

Interventionmg/dL (Mean)
Aripiprazole176.07
Control Group (Olanzapine, Risperidone, or Quetiapine)167.14

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Mean Percent Change From Baseline in Fasting Non-high Density Lipoprotein (Non-HDL) Cholesterol Levels

Based on Last Observation Carried Forward data. Non-HDL cholesterol is defined as the difference between total cholesterol and high-density lipoprotein (HDL) cholesterol levels. Fasting non-HDL cholesterol is defined as the measured fasting HDL cholesterol level subtracted from the measured fasting total cholesterol level. (NCT00857818)
Timeframe: Baseline to Weeks 4, 8, and 16

,
InterventionPercentage of change (Mean)
Week 4Week 8Week 16
Aripiprazole-7.54-18.45-14.72
Control Group (Olanzapine, Risperidone, or Quetiapine)0.19-4.44-2.47

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Number of Participants With Death, Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and 1 or More AEs

AE=any new untoward medical event or worsening of a preexisting medical condition that may or may not be causally related to treatment. SAE=any untoward medical occurrence that at any dose results in death; is life-threatening, a congenital anomaly/birth defect, or an important medical event; requires or prolongs inpatient hospitalization, or results in persistent or significant incapacity or drug dependency or abuse. (NCT00857818)
Timeframe: Baseline to Week 16, continuously

,
InterventionParticipants (Number)
DeathsSAEsAEs leading to discontinuation1 or more AEs
Aripiprazole02311
Control Group (Olanzapine, Risperidone, or Quetiapine)0006

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Change in 17 Item Hamilton Rating Scale for Depression (HAM-D-17)

The Hamilton Rating Scale for Depression (HAM-D-17) is a 17-item clinician-rated measure that queries symptoms of depression, with a possible total score ranging for 0 to 52. A total score of 0-7 indicates no depression, a total score of 8-12 indicates doubtful depression, a total score of 13-17 indicates mild depression, a total score of 18-24 indicates moderate depression and a total score of 25-52 indicates severe depression. (NCT00868374)
Timeframe: Week 0 - Week 8

Interventionunits on a scale (Mean)
Quetiapine XR-0.5
Placebo3.9

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Global Assessment of Functioning Scale (GAF)

Numeric scale (1 through 100) used by mental health clinicians and physicians to rate subjectively the social, occupational, and psychological functioning of adults. 100 is the highest level of functioning. O is the least functional (NCT00880919)
Timeframe: Change in Global Assessment of Functioning from Baseline to 8 weeks

Interventionunits on a scale (Mean)
Quetiapine XR 150 mg/Day (n=33),1.05
Quetiapine XR 300 mg/Day (n=33),1.04
Placebo (n=29).0.62

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Montgomery-Åsberg Depression Rating Scale (MADRS)

"Nine criteria rated on a six-point anchored rating scale of 0 to 6, yielding a total score of 0 to 60. O is the least and 6 is the highest~0 to 6 - normal /symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression >34 - severe depression." (NCT00880919)
Timeframe: baseline to 8 weeks

Interventionunits on a scale (Mean)
Quetiapine XR 150 mg/Day (n=33)-0.85
Quetiapine XR 300 mg/Day (n=33)-1.05
Placebo (n=29)-0.59

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Sheehan Disability Scale (SDS)

Three self-rated items, on a scale of 0-10. 0 is unimpaired 10 is highly impaired This measures functional impairment (NCT00880919)
Timeframe: Change in functional impairment from Baseline to 8 weeks

Interventionunits on a scale (Mean)
Quetiapine XR 150 mg/Day (n=33),-0.85
Quetiapine XR 300 mg/Day (n=33),-1.11
Placebo (n=29).0.58

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Symptom Checklist -90-Revised (SCL-90-R)

90 items measured on a Likert scale via self-report. Scale is 0-5 stating 0= strongly disagree and 5 is Strongly agree Measures psychological problems and symptoms (NCT00880919)
Timeframe: Change in psychological problems and symptoms from Baseline to 8 weeks

Interventionunits on a scale (Mean)
Quetiapine XR 150 mg/Day (n=33),-0.11
Quetiapine XR 300 mg/Day (n=33),-0.12
Placebo (n=29).-0.07

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Young Mania Rating Scale (YMS)

Eleven-item multiple choice diagnostic questionnaire, yielding total scores of 0-60. 0-4 rating 0-being least likely and 4 being most likely This scale assess manic symptoms (NCT00880919)
Timeframe: Change in manic symptoms from Baseline to 8 weeks

Interventionunits on a scale (Mean)
Quetiapine XR 150 mg/Day (n=33),-0.26
Quetiapine XR 300 mg/Day (n=33),-0.30
Placebo (n=29).0.11

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Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD)

This is an assessment of change in DSM-IV borderline psychopathology. Consisting of nine criteria rated on a five-point anchored rating scale of 0 to 4, yielding a total score of 0 to 36. 0 being the best and 4 meaning the worse. (NCT00880919)
Timeframe: baseline, weekly until week 8

Interventionunits on a scale (Mean)
Quetiapine XR 150 mg/Day (n=33),-1.22
Quetiapine XR 300 mg/Day (n=33),-0.99
Placebo (n=29).-0.75

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Overt Aggression Scale - Modified (OAS-M)

Four part behavior rating scale designed to measure four types of aggressive behavior as witnessed in the past week. Each section consists of five questions. Total scores on the MOAS range from 0-40. 0 is the best and 40 is the worst of symptoms Reduction in scores shows a change of symptoms. (NCT00880919)
Timeframe: Change from Baseline Overt Aggression Scale - Modified to 8 weeks

Interventionunits on a scale (Mean)
Quetiapine XR 150 mg/Day (n=33),-1.92
Quetiapine XR 300 mg/Day (n=33),-1.82
Placebo (n=29).-0.37

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Barratt Impulsiveness Scale (BIS)

30-item self-report questionnaire, that is scored to yield a total score, three second-order factors, and six first-order factors. patients rate the questions 1-4 1 being the least and 4 being the most. (NCT00880919)
Timeframe: Change in Impulsiveness from Baseline to 8 weeks

Interventionunits on a scale (Mean)
Quetiapine XR 150 mg/Day (n=33),-0.73
Quetiapine XR 300 mg/Day (n=33),-0.83
Placebo (n=29).-.59

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Borderline Evaluation of Severity Over Time (BEST)

Scale including 15 items and three subscales. All items are rated on a Likert-like scale. A correction factor of 15 is added to yield the final score which can range from 12 (best) to 72 (worst). (NCT00880919)
Timeframe: Baseline to 8 weeks

Interventionunits on a scale (Mean)
Quetiapine XR 150 mg/Day (n=33),-2.10
Quetiapine XR 300 mg/Day (n=33),-1.97
Placebo (n=29).-0.91

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Change From Baseline in PANSS Aggression, Hostility Clusters Score at the End of Treatment at Day 42

"6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7 (better to worse).~1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme" (NCT00882518)
Timeframe: Baseline and 6 weeks

Interventionscores on a scale (Least Squares Mean)
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)-4.8
Chlorpromazine-5.4

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Change From Baseline in PANSS Depression Clusters Score at the End of Treatment at Day 42

"6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7 (better to worse).~1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme" (NCT00882518)
Timeframe: Baseline and 6 weeks

Interventionscores on a scale (Least Squares Mean)
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)-1.8
Chlorpromazine-1.7

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Percentage of Patients With Clinical Global Impression (CGI) Global Improvement Rating Less Than or Equal to 3 at the End of Treatment at Day 42

"6 weeks minus baseline. The number of patients with CGI Global Improvement (CGI-I) rating at least minimally improved at the end of treatment at Day 42 was counted, and then got the proportion among all the patients.CGI-I is scored to rate the patient's change from baseline CGI on a seven-point scale (1=Very much improved, 7=Very much worse.)" (NCT00882518)
Timeframe: Baseline and 6 weeks

Interventionpercentage of participants (Number)
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)87.6
Chlorpromazine88.9

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Number of Patients Achieving a Reduction of at Least 30% From Baseline PANSS Total Score at the End of Treatment at Day 42

"6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7 (better to worse).Total scores range 30-210 from better to worse.~1 =Absent,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme." (NCT00882518)
Timeframe: Baseline and 6 weeks

InterventionPercentage of participants (Number)
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)57.7
Chlorpromazine66.3

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Change in the CGI Severity of Illness Score From Baseline at the End of Treatment at Day 42

6 weeks minus baseline The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale rating the severity of the patient's illness. The patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill. (NCT00882518)
Timeframe: Baseline and 6 weeks

Interventionscores on a scale (Least Squares Mean)
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)-1.8
Chlorpromazine-2.1

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Change From Baseline of the Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment at Day 42

6 weeks minus baseline.PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. Total scores range 30-210 from better to worse. (NCT00882518)
Timeframe: Baseline and 6 weeks

Interventionscores on a scale (Least Squares Mean)
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)-33.4
Chlorpromazine-35.9

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Change From Baseline in PANSS Positive Subscale Score at the End of Treatment at Day 42

6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. 1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme The PANSS positive subscale score is the sum of the 7 positive item scores (ie, delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility) and ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. (NCT00882518)
Timeframe: Baseline and 6 weeks

Interventionscores on a scale (Least Squares Mean)
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)-9.9
Chlorpromazine-11.1

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Change From Baseline in PANSS General Psychopathological Subscale Score at the End of Treatment at Day 42

The PANSS psychopathological subscale score is the sum of 16 item scores(somatic concern, anxiety, guilt feelings, tension, mannerisms and posturing, depression, motor retardation, uncooperativeness, unusual thought content, disorientation, poor attention, lack of judgment and insight, disturbance of volition, poor impulse control, preoccupation, active social avoidance), ranges from 16 to 112. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. (NCT00882518)
Timeframe: Baseline and 6 weeks

Interventionscores on a scale (Least Squares Mean)
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)-12.9
Chlorpromazine-13.9

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Change From Baseline in PANSS Negative Subscale Score at the End of Treatment at Day 42

6 weeks minus baseline PANSS scale is a 30-item scale where each symptom is rated on a severity scale ranging from 1-7. 1 =Absent ,2 =Minimal, 3 =Mild, 4 =Moderate, 5 =Moderate severe, 6 =Severe, 7= Extreme The PANSS negative subscale score is the sum of the 7 item scores (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, stereotyped thinking), ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. (NCT00882518)
Timeframe: Baseline and 6 weeks

Interventionscores on a scale (Least Squares Mean)
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)-5.9
Chlorpromazine-6.7

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Change in Young Mania Rating Scale (YMRS) Total Score.

"The YMRS is a rating scale to assess manic symptoms. The scale has 11 items and is based upon patient's subjective report of his or hers clinical condition over the previous 48 hours.~The mean change in YMRS Total score reported was calculated as baseline - week 8.~The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania)." (NCT00883493)
Timeframe: baseline, 8 weeks

Interventionscores on a scale (Mean)
Quetiapine XR2.3
Quatiapine XR + Lithium2.2

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Change in the Pittsburgh Sleep Quality Index (PSQI)Total Score.

"The mean change in PSQI score from baseline to final assessment at week 8 was calculated as baseline - week 8.~PSQI evaluates 7 areas of quality and pattern of sleep: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence). Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality." (NCT00883493)
Timeframe: Baseline, 8 weeks

InterventionScores on a scale (Mean)
Quetiapine XR3.7
Quatiapine XR + Lithium5.0

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Change in the Clinical Global Impression Severity (CGI-S) Score.

"The reported mean change in the CGI-S score was calculated as baseline - week 8.~CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. A patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill." (NCT00883493)
Timeframe: baseline, 8 weeks

Interventionscores on a scale (Mean)
Quetiapine XR3.1
Quatiapine XR + Lithium3.3

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Response Rate for MADRS.

"Response rate defined as the percentage of patients with a ≥50% reduction from baseline in the MADRS total score to the final assessment at week 8.~The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms." (NCT00883493)
Timeframe: baseline, week 8

Interventionpercentage of participants (Number)
Quetiapine XR93.2
Quatiapine XR + Lithium92.9

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Treatment Satisfaction Questionnaire (TSQ) Scores.

"The 14-item TAQ questionnaire evaluates the patient's overall level of satisfaction with the study medication, the effectiveness, side effects and convenience of the medication.~Effectiveness, side effects, convenience and global satisfaction is rated on a scale of 0 being the worst and 100 being very effective, no side effects or very convenient or very satisfied. Overall satisfaction is rated over a score of 5 and 5 being the best overall satisfaction." (NCT00883493)
Timeframe: baseline, 8 weeks

,
InterventionScores on a scale (Mean)
Effectivenes, baselineEffectivenes, week 8Side effects, baselineSide effects, week 8Convenience, baselineConvenience, week 8Global satisfaction, baselineGlobal satisfaction, week 8
Quatiapine XR + Lithium36.766.744.450.452.872.935.070.7
Quetiapine XR42.768.741.758.253.873.637.469.4

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Change in Hamilton Rating Scale for Anxiety (HAM-A) Total Score

"The mean change in HAM-A total score from baseline to final assessment was calculated by subtracting the HAM-A Total score assessed at week 8 from the total score assessed at the baseline (baseline - week 8).~The HAM-A is a 14-item scale that assesses anxiety symptoms of anxiety such as anxious mood, tension or fears. Each item is scored on a 5-point scale, ranging from 0=not present to 4=severe. Sum the scores from all 14 parameters gives the HAM-A Total Score which may range from 0 (min) to 56 (max)." (NCT00883493)
Timeframe: baseline, 8 weeks

Interventionscores on a scale (Mean)
Quetiapine XR17.5
Quatiapine XR + Lithium17.7

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Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.

"The change of MADRS Total Score from baseline to the end of treatment was calculated by subtracting the MADRS Total Score assessed at week 8 from the baseline one (Baseline - 8 weeks).~The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms." (NCT00883493)
Timeframe: Baseline, 8 weeks

Interventionscores on a scale (Mean)
Quetiapine XR23.7
Quatiapine XR + Lithium24.3

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Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Score.

"The mean change in (Q-LES-Q-Short Form) Total Score from baseline to week 8 was calculated by subtracting the 8 week value from baseline value (baseline - week 8).~The Q-LES-Q-SF is a patient self assessment questionnaire consisting of 16 self-rated questions (1 being very poor - 5 very good); the first 14 will be incorporated into a total score. Higher scores indicate better quality of life." (NCT00883493)
Timeframe: baseline, 8 weeks

Interventionscores on a scale (Mean)
Quetiapine XR-17.9
Quatiapine XR + Lithium-18.8

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Hamilton Rating Scale for Depression (HAM-D) Total Score.

"The mean change of HAM-D Total Score from baseline to the end of treatment was calculated by subtracting the HAM-D Total Score assessed at week 8 from the baseline one (Baseline - week 8).~HAM-D is a multiple choice questionnaire used to rate the severity of a patient's major depression. It consists of 17 different items with possible scores from 0 to 4 or 0 to 2 or 0 to 6 depending on the items. Sum the total of all seventeen items gives the HAM-D Total Score, which may range from 0 (min) to 53 (max). The higher the score, the more severe the depression." (NCT00883493)
Timeframe: Baseline, 8 Weeks

Interventionscores on a scale (Mean)
Quetiapine XR20.5
Quatiapine XR + Lithium21.0

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Change in the Sheehan Disability Scale (SDS) Total Score.

"The mean change in the SDS Total score from baseline to week 8 (baseline- week 8).~Sheehan Disability Scale is a 5 item scale, with a visual analog scale evaluating work/school work, social life and family life ranging from 0 to a maximum score of 30. Each one of the 3 domains is rated from 0-10 (no impairment to most severe impairment) with evaluation of not at all (0), mild (1-3), moderate (4-6), marked (7-9) and extreme (10) disability. A total score will be calculated. A score of 30 indicates most severe impairment." (NCT00883493)
Timeframe: baseline, 8 weeks

Interventionscores on a scale (Mean)
Quetiapine XR14.4
Quatiapine XR + Lithium14.3

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Area Under the Modified Bond-Lader Visual Analog Scale-time Curve

Area under the Modified Bond-Lader VAS-time curve is calculated by the linear trapezoidal formula which equals sum of (Ck+Ck+1)/2 multiplied by the time interval between k and k+1 observations, where Ck and Ck+1 are the corresponding the intensity of sedation evaluations measured by the Modified Bond-Lader VAS from 1 to 14 hours post-dose (NCT00926393)
Timeframe: During Day 2 (50 mg)

Interventionmm * hour (Least Squares Mean)
Quetiapine IR1061.12
Quetiapine XR988.842

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Change in Abnormal Involuntary Movement Scale (AIMS) Total Score

AIMS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4. Change : total score at day 7 minus total score at randomization. Increase in Change of total score indicates an increase in abnormal voluntary movements. (NCT00926393)
Timeframe: Randomization to Day 7

Interventionunits on scale (Mean)
Quetiapine IR-0.01
Quetiapine XR-0.04

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Change in Barnes Akathisia Rating Scale (BARS) Global Score

BARS global score is the 4th individual-item score on the BARS scale,the Global Assessment of Akathisia, with the score ranging from 0 to 5. Change : score at day 7 minus score at randomization. Increase in Change of BARS global score indicates an increase in akathisia. (NCT00926393)
Timeframe: Randomization to Day 7

Interventionunits on scale (Mean)
Quetiapine IR-0.07
Quetiapine XR-0.09

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Change in Simpson-Angus Scale (SAS) Total Score

SAS total score is the sum of the 10 individual-item scores (range:0-40), with the score for each item ranging from 0 to 4, higher scores indicate greater severity of Parkinsonian symptoms. Change : total score at day 7 minus total score at randomization. Increase in Change of total score indicates an increase in extrapyramidal motor symptoms. (NCT00926393)
Timeframe: Randomization to Day 7

Interventionunits on scale (Mean)
Quetiapine IR-0.1
Quetiapine XR0.1

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Maximum Intensity Modified Bond-Lader Visual Analog Scale Score

The Maximum Intensity Modified Bond-Lader VAS after dose (MaxIntVAS) is calculated as maximum possible value of VAS during that day at any from 1, 2, 3, 4, 5, 12, 13, 14 hours post-dose assessments (NCT00926393)
Timeframe: During Day 2 (50 mg)

Interventionunits on scale (Least Squares Mean)
Quetiapine IR99.929
Quetiapine XR96.937

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Modified Bond-Lader Visual Analog Scale Score After 100-mg Dose (Day 3)

The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100. (NCT00926393)
Timeframe: At 1 hour post-dose, Day 3 (100 mg)

Interventionunits on scale (Least Squares Mean)
Quetiapine IR51.521
Quetiapine XR29.146

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Modified Bond-Lader Visual Analog Scale Score After 200-mg Dose (Day 4)

The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100. (NCT00926393)
Timeframe: At 1 hour post-dose, Day 4 (200 mg)

Interventionunits on scale (Least Squares Mean)
Quetiapine IR48.336
Quetiapine XR30.130

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Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 5)

The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100. (NCT00926393)
Timeframe: At 1 hour post-dose, Day 5 (300 mg)

Interventionunits on scale (Least Squares Mean)
Quetiapine IR49.414
Quetiapine XR32.626

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Modified Bond-Lader Visual Analog Scale Score After 300-mg Dose (Day 6)

The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100. (NCT00926393)
Timeframe: At 1 hour post-dose, Day 6 (300 mg)

Interventionunits on scale (Least Squares Mean)
Quetiapine IR48.959
Quetiapine XR30.144

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Modified Bond-Lader Visual Analog Scale Score After 50-mg Dose (Day 2)

The Modified Bond-Lader Visual Analog Scale (VAS) uses a 100 mm line, each with a set of opposing adjectives at either end:Alert (=0) - Drowsy (=100); If patient is sleeping the Bond-Lader VAS will be assign a score of 100. (NCT00926393)
Timeframe: At 1 hour post-dose, Day 2 (50 mg)

Interventionunits on scale (Least Squares Mean)
Quetiapine IR45.022
Quetiapine XR32.472

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Number of Patients With Potential Extrapyramidal Symptoms (EPS)

Number of patients with adverse events potentially associated with EPS collected by MedDRA Preferred Terms as akathisia, extrapyramidal disorder, restlessness (NCT00926393)
Timeframe: From start of the study treatment to last dose plus 30 days

InterventionPatients (Number)
Quetiapine IR8
Quetiapine XR2

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Number of Patients With Potential Somnolence

Number of patients with adverse events potentially associated with somnolence collected by MedDRA Preferred Terms as lethargy, sedation, somnolence (NCT00926393)
Timeframe: From start of the study treatment to last dose plus 30 days

InterventionPatients (Number)
Quetiapine IR11
Quetiapine XR12

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Time to Maximum Intensity Modified Bond-Lader Visual Analog Scale Score

Time (Tmax) to Maximum Intensity Modified Bond-Lader VAS after dose is corresponding assessment time (one from 1, 2, 3, 4, 5, 12, 13, 14 hours post-dose) of MaxIntVas (NCT00926393)
Timeframe: During Day 2 (50 mg)

InterventionHours (Least Squares Mean)
Quetiapine IR3.685
Quetiapine XR4.254

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Change From Baseline to Day 43 in Each YMRS Item Score No. 9

The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. . This analysis is for Item 9 (disruptive-aggressive behavior) which ranges from 0 to 8 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. (NCT00931723)
Timeframe: Change from baseline to Day 43

InterventionScores on a scale (Least Squares Mean)
Lithium+Quetiapine XR-2.5
Placebo+Quetiapine XR-2.1

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Change From Baseline to Day 43 in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score

The MADRS is a 10-item scale that evaluates depressive symptoms. Each MADRS item is rated on a 0 to 6 scale. Higher MADRS scores indicate higher levels of depressive symptoms. (NCT00931723)
Timeframe: Change from baseline to Day 43.

InterventionScores on a scale (Least Squares Mean)
Lithium+Quetiapine XR-4.8
Placebo+Quetiapine XR-4.1

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Change From Baseline to Day 43 in PANSS Activation Subscale Score

The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS activation subscale score for effect on agitation and aggression is the sum of 6 PANSS individual items (ie, hostility, poor impulse control, excitement, uncooperativeness, poor rapport and tension) and ranges from 6 to 42. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. (NCT00931723)
Timeframe: Change from baseline to Day 43

InterventionScores on a scale (Least Squares Mean)
Lithium+Quetiapine XR-7.1
Placebo+Quetiapine XR-5.9

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Change From Baseline to Day 43 in PANSS Positive Subscale Score

The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS positive subscale score is the sum of the 7 positive item scores (ie, delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution and hostility) and ranges from 7 to 49. A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. (NCT00931723)
Timeframe: Change from baseline to Day 43

InterventionScores on a scale (Least Squares Mean)
Lithium+Quetiapine XR-8.1
Placebo+Quetiapine XR-7.0

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Change From Baseline to Day 43 in Positive and Negative Syndrome Scale (PANSS) Total Score

The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia and are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score is the sum of all 30 individual-item scores and ranges from 30 to 210.A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. (NCT00931723)
Timeframe: Change from baseline to Day 43

InterventionScores on a scale (Least Squares Mean)
Lithium+Quetiapine XR-19.2
Placebo+Quetiapine XR-15.6

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Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Final Assessment (Day 43)

The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania). (NCT00931723)
Timeframe: Change in YMRS total score from baseline to Day 43.

InterventionScores on a scale (Least Squares Mean)
Lithium+Quetiapine XR-22.8
Placebo+Quetiapine XR-20.1

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Improvement of Overall Bipolar Illness

"The number of patients with a CGI-BP-C of Much or Very much improved in overall bipolar illness assessment at Day 43 was calculated.~The CGI-BP-C scale rates how much the patient's illness has improved or worsened compared to the phase immediately preceding treatment and is scored on a scale from 1 to 8 (1=very much improved to 7=very much worse; 8=not applicable). A missing score will be used when a scale scored as 8 (not applicable). CGI-BP-C scores >4 indicate worsening, while scores <4 indicate improvement." (NCT00931723)
Timeframe: Day 43.

InterventionParticipants (Number)
Lithium+Quetiapine XR134
Placebo+Quetiapine XR125

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Remission

"The number of patients with clinically significant remission (defined as YMRS total score ≤12) from Days 8 to 43) was calculated.~The Young Mania Rating Scale total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or 50% reduction) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania)." (NCT00931723)
Timeframe: Days 8 to 43

InterventionParticipants (Number)
Lithium+Quetiapine XR125
Placebo+Quetiapine XR105

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The Number of Patients With Clinically Significant Response.

The number of patients with clinically significant response (defined as ≥50% reduction from baseline to Day 43 in the YMRS total score) was calculated. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or 50% reduction) from baseline indicates a reduction (or improvement) in manic symptoms. (NCT00931723)
Timeframe: 43 days (from baseline to Day 43)

InterventionParticipants (Number)
Lithium+Quetiapine XR137
Placebo+Quetiapine XR120

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Change From Baseline to Day 43 in Each YMRS Item Score No. 5

The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 5 (Irritability) which ranges from 0 to 8 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. (NCT00931723)
Timeframe: Change from baseline to Day 43

InterventionScores on a scale (Least Squares Mean)
Lithium+Quetiapine XR-3.1
Placebo+Quetiapine XR-2.8

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Change From Baseline to Day 43 in CGI-BP-C (Clinical Global Impressions for Bipolar Disorder-Change From Preceding Phase)

The CGI-BP-C scale rates how much the patient's illness has improved or worsened compared to the phase immediately preceding treatment and is scored on a scale from 1 to 8 (1=very much improved to 7=very much worse; 8=not applicable). A missing score will be used when a scale scored as 8 (not applicable). CGI-BP-C scores >4 indicate worsening, while scores <4 indicate improvement. (NCT00931723)
Timeframe: Change from baseline to Day 43

InterventionScores on a scale (Least Squares Mean)
Lithium+Quetiapine XR1.7
Placebo+Quetiapine XR1.9

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Change From Baseline to Day 43 in CGI-BP-S (Clinical Global Impressions for Bipolar Disorder-Severity of Illness)

The CGI-BP-S scale rates the severity of the patient's illness at the time of assessment and is scored from 1 to 7 (1=normal, not ill to 7=very severely ill). Higher CGI-BP-S scores indicate greater illness severity. (NCT00931723)
Timeframe: Change from baseline to Day 43.

InterventionScores on a scale (Least Squares Mean)
Lithium+Quetiapine XR-2.5
Placebo+Quetiapine XR-2.2

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Change From Baseline to Day 43 in Each YMRS Item Score No. 1

The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 1 (Elevated mood) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. (NCT00931723)
Timeframe: Change from baseline to Day 43

InterventionScores on a scale (Least Squares Mean)
Lithium+Quetiapine XR-1.8
Placebo+Quetiapine XR-1.6

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Change From Baseline to Day 43 in Each YMRS Item Score No. 10

The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. This analysis is for Item 10 (appearance) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. (NCT00931723)
Timeframe: Change from baseline to Day 43

InterventionScores on a scale (Least Squares Mean)
Lithium+Quetiapine XR-1.1
Placebo+Quetiapine XR-1.0

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Change From Baseline to Day 43 in Each YMRS Item Score No. 11

The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. This analysis is for Item 11 (insight) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. (NCT00931723)
Timeframe: Change from baseline to Day 43

InterventionScores on a scale (Least Squares Mean)
Lithium+Quetiapine XR-1.4
Placebo+Quetiapine XR-1.2

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Change From Baseline to Day 43 in Each YMRS Item Score No. 2

The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 2 (increased motor activity-energy) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. (NCT00931723)
Timeframe: Change from baseline to Day 43

InterventionScores on a scale (Least Squares Mean)
Lithium+Quetiapine XR-1.9
Placebo+Quetiapine XR-1.7

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Change From Baseline to Day 43 in Each YMRS Item Score No. 3

The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 3 (sexual interest) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. (NCT00931723)
Timeframe: Change from baseline to Day 43

InterventionScores on a scale (Least Squares Mean)
Lithium+Quetiapine XR-1.3
Placebo+Quetiapine XR-1.1

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Change From Baseline to Day 43 in Each YMRS Item Score No. 4

The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 4 (sleep) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. (NCT00931723)
Timeframe: Change from baseline to Day 43

InterventionScores on a scale (Least Squares Mean)
Lithium+Quetiapine XR-2.0
Placebo+Quetiapine XR-1.8

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Change From Baseline to Day 43 in Each YMRS Item Score No. 6

The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4 (0=normal). This analysis is for Item 6 (speech-rate and amount) which ranges from 0 to 8 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. (NCT00931723)
Timeframe: Change from baseline to Day 43

InterventionScores on a scale (Least Squares Mean)
Lithium+Quetiapine XR-3.1
Placebo+Quetiapine XR-2.9

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Change From Baseline to Day 43 in Each YMRS Item Score No. 7

The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. This analysis is for Item 7 (language-thought disorder) which ranges from 0 to 4 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. (NCT00931723)
Timeframe: Change from baseline to Day 43

InterventionScores on a scale (Least Squares Mean)
Lithium+Quetiapine XR-1.5
Placebo+Quetiapine XR-1.4

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Change From Baseline to Day 43 in Each YMRS Item Score No. 8

The YMRS assesses severity of mania in bipolar disorder. It rates 4 core items from 0 to 8 (0=normal); the other 7 items are rated from 0 to 4. This analysis is for Item 8 (content) which ranges from 0 to 8 where higher scores indicate more severe symptoms, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. (NCT00931723)
Timeframe: Change from baseline to Day 43

InterventionScores on a scale (Least Squares Mean)
Lithium+Quetiapine XR-3.1
Placebo+Quetiapine XR-2.9

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Change in Hamilton Rating Scale for Anxiety (HAM-A)

The 14-item Hamilton Rating Scale for Anxiety (HAM-A) is an objective assessment of anxiety administered by a trained rater. This version allows scores to range from 0 to 56, where higher scores indicate worsening anxiety. (NCT00951483)
Timeframe: Baseline and 12 weeks

Interventionunits on a scale (Median)
Intervention Cohort Baseline22.00
Intervention Cohort End of Treatment6.00

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Change in Hamilton Rating Scale for Depression With 21 Items (HAMD-21)

The 21-item Hamilton Rating Scale for Depression (HAMD-21) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 52, where higher scores indicate worsening mood. (NCT00951483)
Timeframe: Baseline and 12 weeks

Interventionunits on a scale (Median)
Intervention Cohort Baseline26.50
Intervention Cohort End of Treatment6.50

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Change in Hamilton Rating Scale for Depression With Seven Items (HAM-D-7)

The seven item Hamilton Rating Scale for Depression (HAMD-7) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 22, where higher scores indicate worsening mood. (NCT00951483)
Timeframe: Baseline and 12 weeks

Interventionunits on a scale (Median)
Intervention Cohort Baseline15.00
Intervention Cohort End of Treatment3.00

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Change in Hamilton Rating Scale for Depression With 17 Items (HAM-D-17)

The 17-item Hamilton Rating Scale for Depression (HAMD-17) is an objective assessment of depression administered by a trained rater. This version allows scores to range from 0 to 52, where higher scores indicate worsening mood. (NCT00951483)
Timeframe: Baseline and 12 weeks

Interventionunits on a scale (Median)
Intervention Cohort Baseline24.00
Intervention Cohort End of Treatment5.50

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Change in Beck Depression Inventory (BDI)

The 21-item Beck Depression Inventory (BDI) is a subjective self-report assessment of depression. This version allows scores to range from 0 to 63, where higher scores indicate worsening mood. (NCT00951483)
Timeframe: Baseline and 12 weeks

Interventionunits on a scale (Median)
Intervention Cohort Baseline25.00
Intervention Cohort End of Treatment6.00

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Change in 14-item Perceived Stress Scale (PSS-14)

The 14-item Perceived Stress Scale (PSS-14) is a subjective self-report assessment of stress. Each item is rated on a five point frequency scale ranging from 0 = never experiencing the stress symptom to 4 = Very often experiencing the stress symptom. Scores range from 0 to 56, where higher scores indicate higher stress. (NCT00951483)
Timeframe: Baseline and 12 weeks

Interventionunits on a scale (Median)
Intervention Cohort Baseline50.00
Intervention Cohort End of Treatment35.00

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C-Reactive Protein at 12 Weeks

To compare C-Reactive Protein between the treatment and healthy control groups at 12 weeks post treatment. (NCT00951483)
Timeframe: 12 weeks

Interventionmg/L (Median)
Experimental Cohort3.31
Healthy Control0.50

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Change From Baseline to Final Visit at Day 21 in PANSS Negative, General Psychopathological Scores

Negative scale includes 7 items (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking)and is calculated by adding the negative subscale item scores. Minimum score is 7, maximum score is 49. General Psychopathology scale includes 16 Items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). Minimum score is 16, maximum score is 112. The higher score- the worse outcome. Measure includes PANSS-Negative (range 8-37), PANSS-General Psychopathological (PANSS-G)(range 17-70), total PANSS score (range 37-143), PANSS aggression, hostility and depression cluster scores (range 4-19). (NCT00954122)
Timeframe: Baseline and Day 21

InterventionScores on a scale (Mean)
Quetiapine Fumarate XR-5.7

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Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S)

"Clinical Global Impression, Severity (CGI-S) is a single-item (7-point) scale that evaluates the overall severity of the subject's mental illness. A reduction in score indicates an improvement in the subject's condition. The CGI-S assessment should be based upon the subject's symptoms during the previous week.~Change from baseline in CGI-S score is calculated by subtracting the CGI-S score at baseline from the CGI-S score at the relevant time point." (NCT00954122)
Timeframe: Baseline and Day 21

Interventionscores on a scale (Mean)
Quetiapine Fumarate XR-1.2

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Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score

Positive and Negative Syndrome Scale (PANSS) total score is a medical scale used for measuring symptom severity of patients with schizophrenia. It is calculated by adding together PANSS-Positive (minimum score = 7, maximum score = 49, PANSS-Negative (minimum score = 7, maximum score = 49), PANSS-General Psychopathological (PANSS-G) subscale scores (minimum score = 16, maximum score = 112), supplementary subscale item scores. The minimum is 30, maximum is 210. Total PANSS score classification: Mildly ill 58- 74, Moderately ill 75-94, Markly ill 95- 115, Severely ill >116. (NCT00954122)
Timeframe: Baseline and Day 21

InterventionScores on a scale (Mean)
Quetiapine Fumarate XR-33.2

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Change From Baseline in Absolute Clinical Global Impression-Improvement (CGI-I) Scale

"Clinical Global Impression, Improvement (CGI-I) is a single-item (7-point) scale that evaluates the overall improvement in the subject's mental. A reduction in score indicates an improvement in the subject's condition. This assessment is based on the improvement since initiation of the study treatment.~Change in CGI-I score is analyzed by comparing CSI-score at the relevant time point to the baseline CGI-I score." (NCT00954122)
Timeframe: Baseline and Day 21

InterventionScores on a scale (Mean)
BaselineDay 21
Quetiapine Fumarate XR3.92.4

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Change of the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score Compared From Baseline to Day 21.

"Excited Component was used to evaluate the control of agitation and aggression in patients with schizophrenia.~Difference in mean score at baseline and day 21 is used to assess the improvement. It is shown by reduction in mean score and confirmed by p value lower than 0,05.~Positive and Negative Syndrome Scale Excited Component (PANSS-EC) is a subscale score which is calculated by adding together the following item scores: excitement (positive subscale item 4); hostility (positive subscale item 7); tension (general subscale item 4); uncooperativeness (general subscale item 8); poor impulse control (general subscale item 14).~This is rated on a 7-point Likert scale from 'absent' to 'extremely severe' (score range 5 to 35 points; mean scores = 20 points clinically corresponds to severe agitation)." (NCT00954122)
Timeframe: Baseline and Day 21

InterventionScores on a scale (Mean)
Quetiapine Fumarate XR-33.2

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Change From Baseline to Final Visit at Day 21 in PANSS Positive, General Psychopathological Scores.

"Positive scale includes 7 Items (Delusions, Conceptual disorganization, Hallucinations, Hyperactivity, Grandiosity, Suspiciousness/persecution, Hostility)and is calculated by adding the positive subscale item scores. Minimum score is 7, maximum score is 49. General Psychopathology scale:16 items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). Minimum score is 16, maximum score is 112. The higher score- the worse outcome. The biggest reduction of score from baseline- a better efficacy.~Measure includes PANSS-Positive (range 8-30), PANSS-General Psychopathological (PANSS-G)(range 17-70), total PANSS score (range 37-143), PANSS aggression, hostility and depression cluster scores (range 4-19)." (NCT00954122)
Timeframe: Baseline and Day 21

InterventionScores on a scale (Mean)
Quetiapine Fumarate XR-9.3

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Change From Baseline in Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score

PANSS- Excited Component (EC) subscale score will be calculated by adding together the following item scores: excitement (positive subscale item 4); hostility (positive subscale item 7); tension (general subscale item 4); uncooperativeness (general subscale item 8); poor impulse control (general subscale item 14). This is rated on a 7-point Likert scale from 'absent' to 'extremely severe' (score range 5 to 35 points; mean scores = 20 points clinically corresponds to severe agitation). Lower value gives the better outcome. (NCT00954122)
Timeframe: Baseline and Day 21

InterventionScores on a scale (Mean)
Quetiapine Fumarate XR-7.5

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Maximum Tolerated Dose of Quetiapine

Mean maximum tolerated dose of quetiapine (NCT00954681)
Timeframe: assesssed daily during 8 weeks of study, mean maximum tolerated dose reported

Interventionmilligrams (Mean)
Open-Label Quetiapine Treatment197

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RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Attention Sub-scale Scores at Baseline and Week 8.

RBANS Attention sub-scale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. (NCT00955474)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
BaselineWeek 8
Quetiapine95.8104.6
Quetiapine With SSRI85.486.1

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Psychosis

Psychosis measured by Brief Psychosis Rating Scale (BPRS) at baseline and 8 weeks. Scores range from 24-168, with 168 bring the most severe. (NCT00955474)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
BaselineLast visit
Quetiapine56.0934.25
Quetiapine With SSRI60.4532.83

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LDL Blood Levels at Baseline and Week 8.

LDL levels at Baseline and Week 8. Normal range < 100 mg/dl. (NCT00955474)
Timeframe: 8 weeks

,
Interventionmg/dl (Mean)
BaselineWeek 8
Quetiapine109121.1
Quetiapine With SSRI94.6123.3

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HDL Blood Levels at Baseline and Week 8.

HDL levels at Baseline and Week 8. Normal range: 35-100 mg/dl. (NCT00955474)
Timeframe: 8 weeks

,
Interventionmg/dl (Mean)
BaselineWeek 8
Quetiapine47.740.8
Quetiapine With SSRI45.340.5

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Blood Level of Triglycerides at Baseline and Week 8.

Level of triglycerides at Baseline and Week 8. Normal range: 40-150mg/dl. (NCT00955474)
Timeframe: 8 weeks

,
Interventionmg/dl (Mean)
BaselineWeek 8
Quetiapine144.9170.6
Quetiapine With SSRI154.25190.5

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RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Language Sub-scale Score.

RBANS Language sub-scale scores at Baseline and Week 8 of study. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. (NCT00955474)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
BaselineWeek 8
Quetiapine80.487.9
Quetiapine With SSRI77.691.1

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Fasting Blood Glucose

Fasting glucose levels collected at Baseline and Week 8. Normal range for fasting glucose is 70-110 mg/dl. (NCT00955474)
Timeframe: 8 weeks

,
Interventionml/dl (Mean)
BaselineWeek 8
Quetiapine91.689.1
Quetiapine and SSRI89.496.8

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Depression

Depression measured with Hamilton Rating Scale for Depression 17 (HAM-D) at baseline and 8 weeks. Ham D 17 scores range from 0-52, 52 being the most severe. (NCT00955474)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
BaselineLast visit
Quetiapine279.57
Quetiapine With SSRI26.7310.14

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CPFQ (Cognitive and Psychological Functioning Questionnaire)

Score on the Cognitive and Psychological Functioning Questionnaire (CPFQ). Scores range from 7-42 with 42 referring to the worst functioning. CPFQ measured at baseline and 8 weeks. (NCT00955474)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
BaselineLast visit
Quetiapine30.823.56
Quetiapine With SSRI29.321.00

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Blood Level of Total Cholesterol Levels Were Collected at Baseline and Week 8.

Cholesterol levels were collected at Baseline and Week 8. Normal cholesterol levels should be <200mg/dl. (NCT00955474)
Timeframe: 8 weeks

,
Interventionmg/dl (Mean)
BaselineWeek 8
Quetiapine184.2188
Quetiapine With SSRI171.8201.7

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Blood Hemoglobin A1C at Baseline and Week 8.

Blood hemoglobin A1C at Baseline and Week 8. Normal range: 3.8%-6.4%. (NCT00955474)
Timeframe: 8 weeks

,
Intervention% glycated hemoglobin (Mean)
BaselineWeek 8
Quetiapine5.65.4
Quetiapine With SSRI5.75.8

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RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Immediate Memory Sub-scale Score

RBANS Immediate Memory sub-scale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. (NCT00955474)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
BaselineWeek 8
Quetiapine83.382.8
Quetiapine With SSRI71.177.9

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RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Total Score

Neuropsychological Assessment. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. RBANS measured at baseline and 8 weeks. (NCT00955474)
Timeframe: 8

,
Interventionunits on a scale (Mean)
BaselineLast visit
Quetiapine77.3877.25
Quetiapine With SSRI70.0078.29

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RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Visuospatial/Constructional Sub-scale.

RBANS Visuospatial/Constructional sub-scales at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. (NCT00955474)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
BaselineWeek 8
Quetiapine70.670.5
Quetiapine With SSRI75.678.3

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RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Delayed Memory Subscale Scores at Baseline and Week 8.

RBANS Delayed Memory subscale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. (NCT00955474)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
BaselineWeek 8
Quetiapine82.472.9
Quetiapine With SSRI69.674.7

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17-item Hamilton Depression Rating Scale (HDRS)

Standard 17-item rating scale for depression used in clinical trials. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate, severe, or very severe depression, and are usually required for entry into a clinical trial. Range of score: 0 - 50. (NCT00982345)
Timeframe: Started: March 2009 Ending March 2011

Interventionunits on a scale (Mean)
Baseline 17-item HDRSPost-treatment at 8 weeks 17-item HDRS
Quetiapine208

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Change From Baseline in GAD Symptomatology at the Week 12 Timepoint.

Changes in anxiety symptomatolgy (NCT01066143)
Timeframe: 12 week

Intervention ()
Seroquel XR0

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Change From Baseline in PTSD Symptomatology at the Week 8 Timepoint.

"We will compare patients' symptomatology at baseline vs. at 8 week timepoint~Specify Full Scale Name and Construct (i.e., indicate what the scale measures if not clear from name): Clinician-Administered PTSD Scale (CAPS)~Include all scale ranges (i.e., minimum and maximum scores) required to interpret any values in the data table: 0-136~For each scale range provided, specify which values are considered to be a better or worse outcome: 0-best, 136 worst~If subscales are combined to compute a total score, consider indicating how subscales are combined (summed, averaged, etc.): summed" (NCT01066156)
Timeframe: 8 weeks

Interventionunits on a scale (Mean)
Seroquel7.3

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Remission

Number of Remitted Participants (defined as 3 consecutive weeks with HRSD-17≤8 and YMRS≤8) (NCT01133821)
Timeframe: 20 weeks

InterventionParticipants (Count of Participants)
IPSRT Plus Quetiapine16
Placebo13

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Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ)-Short Form

Quality of Life Enjoyment and Satisfaction Questionnaire (QLESQ-SF; Total Scores) describes difference in Quality of Life Scores from Baseline to Week 20; The QLESQ-SF is a self-report measure of life satisfaction, with 16 items rated from 1 (very poor) to 5 (very good) to produce a score from 0 to 80 with higher scores indicating better quality of life. In this report, we record change in scores from baseline to follow up (NCT01133821)
Timeframe: 20 weeks

Interventionunits on a scale (Mean)
IPSRT Plus Quetiapine10.6
Placebo4.7

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Time to First Psychiatric Hospitalization

"A time-to parameter looking only at 1 component event of treatment failure: psychiatric hospitalization. Time to first psychiatric hospitalization was admission date of the psychiatric hospitalization recorded in the Assessment of Treatment Failure - Psychiatric Hospitalization." (NCT01157351)
Timeframe: From date of randomization up to Month 15

InterventionDays (Median)
Paliperidone PalmitateNA
Oral AntipsychoticsNA

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Change From Baseline in Personal and Social Performance (PSP) Total Score During Overall Treatment Duration

The PSP score assesses the degree of difficulty a participant exhibit over a 1 month period within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. The investigators rate participants' degree of difficulty in each of the 4 domains using a 6-point Likert scale (from 0=absent to 5=very severe). The domain ratings were then transformed to PSP total score ranging from 1 to 100. Higher PSP total scores denote better functioning. A score between 71 and 100 represents normal to mild degree of dysfunction; a score between 31 and 70 represents varying degree of difficulty; and a score <=30 represents poor function that requires intensive supervision. (NCT01157351)
Timeframe: Baseline up to Month 15

InterventionUnits on a scale (Least Squares Mean)
Paliperidone Palmitate5.75
Oral Antipsychotics5.36

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Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Overall Treatment Duration

The CGI-S rating scale was a 7-point global assessment of symptom severity with scores determined by clinician as follows: 1=Not ill, 2=Very Mild, 3= Mild, 4= Moderate, 5= Marked, 6= Severe, and 7= Extremely Severe. The higher the score the worse the illness. (NCT01157351)
Timeframe: Baseline up to Month 15

InterventionUnits on a scale (Least Squares Mean)
Paliperidone Palmitate-0.48
Oral Antipsychotics-0.43

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Percentage of Participants in Each Event Category of First Treatment Failure

First treatment failure was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation (D/C) of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event. Percentage of participants who experienced treatment failure due to any event and for each specific category of event were assessed. (NCT01157351)
Timeframe: From date of randomization up to Month 15

,
Interventionpercentage of participants (Number)
Treatment Failure Due to Any EventArrest/incarcerationPsychiatric hospitalizationD/C due to safety/tolerabilityTreatment supplementationD/C due to inadequate efficacyIncrease in level of psychiatric servicesSuicide
Oral Antipsychotics53.729.411.93.72.84.11.80
Paliperidone Palmitate39.821.28.06.62.20.41.30

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Time to First Psychiatric Hospitalization or Arrest/Incarceration

A time to parameter looking only at 2 component events of treatment failure: arrest or incarceration, and psychiatric hospitalization. An arrest was defined as the taking of a participant into custody by legal authority, for any reason. Incarceration was defined as involuntary confinement by an officer of the law. Psychiatric hospitalization was an inpatient psychiatric hospitalization that occurred due to the participant's clinically significant worsening of symptoms of schizophrenia. (NCT01157351)
Timeframe: From date of randomization up to Month 15

InterventionDays (Median)
Paliperidone PalmitateNA
Oral Antipsychotics274

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Time to First Treatment Failure

Time to first treatment failure was the time from participant randomization to the first treatment failure, which was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event. (NCT01157351)
Timeframe: From date of randomization up to Month 15

InterventionDays (Median)
Paliperidone Palmitate416
Oral Antipsychotics226

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Number of Very Heavy Drinking Days Per Week

"The number of very heavy drinking days (8 or more drinks per drinking day for men or 6 or more drinks per drinking day for women) per week" (NCT01165541)
Timeframe: 14 Weeks

Interventiondays (Mean)
Quetiapine Fumarate Extended Release (Quetiapine XR)2.1
Quetiapine XR Plus Mirtazapine1.3

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Number of Patients Whose Mood Improved According to MADRS and YMRS Scale Scores.

The primary outcome measure was assessed by 50% reduction in: 1. depression scores on the Montgomery Asberg Depression Rating Scale (MADRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms 2. mania scores on the Young Mania Rating Scale (YMRS), which ranges from 0 indicating no symptoms to 60 indicating most symptoms. (NCT01195363)
Timeframe: Baseline visit to week 24

,
Interventionparticipants (Number)
MADRSYMRS
Active Quetiapine S.R., 200-600mg, po, qd44
Placebo Quetiapine S.R. 200-600mg, po, qd44

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Mean Treatment Satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM)

"TSQM is a 14-item questionnaire with 4 sub-scales: effectiveness of the medication; treatment side effects; convenience of the medication; global satisfaction with the medication. Scale range 0-100 for each sub-scale, higher=greater satisfaction/milder side effects/greater convenience/greater overall satisfaction.~There are 2 measurement, (after the start of taking study drug) one at end of period 1 and one at end of period 2. That is one measurement per patient per treatment. The mean of all the patients is presented, one mean value per treatment group." (NCT01213836)
Timeframe: Before taking study drug, end of Period 1 and end of Period 2

,
Interventionunits on a scale (Mean)
Side EffectsEffectivenessConvenienceOverall Satisfaction
Seroquel IR81.562.263.658.9
Seroquel XR87.965.466.263.0

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Number of Dropouts.

The number of patients who dropped out was counted. (NCT01213836)
Timeframe: Period 1 and Period 2

,
Interventionparticipants (Number)
Period 1Period 2
Seroquel IR20
Seroquel XR30

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Mean for Attentional Standardised Composite Score Based on Performance Scores From the CogState Test Battery Domains Detection (Speed of Processing)and Identification (Attention/Vigilance)

Attentional standardised composite score: Standardised speed of performance score. Higher Score=better performance. Score range minus infinity to plus infinity. Measured at baseline (before study drug administration) and in Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. (Last test day not earlier than after 10 days of randomised)and in Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Last test day not earlier than after 10 days of crossover treatment. (NCT01213836)
Timeframe: Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.

,
Interventionstandardised units (Mean)
Post 1Post 2Post 3
Seroquel IR-0.098-0.131-0.120
Seroquel XR0.002-0.201-0.194

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Mean Overall Sedation as Measured by the Modified Bond-Lader Visual Analogue Scale (VAS) When Administered According to Label

"The modified Bond-Lader VAS: The degree of sedation was marked by the patient on a 100 mm VAS ranging between Alert (=0 mm) and Drowsy (=100 mm). The marked length in millimetres.~There are 3 assessments made in each period (post 1, 2 and 3 for each period). That is three measurements per patient per treatment. The mean is an overall mean of all the recordings in all patients, one mean value per treatment group." (NCT01213836)
Timeframe: Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.

Interventionunits on a scale (Mean)
Seroquel XR23.5
Seroquel IR28.6

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Mean Overall Sedation as Measured by the Stanford Sleepiness Scale When Administered According to Label

"Stanford Sleepiness Scale: The sleepiness was assessed by the patient on a 7 item rating scale ranging from 1 (Feeling active and vital) to 7 (Almost in reverie).~There are 3 assessments made in each period (post 1, 2 and 3 for each period). That is three measurements per patient per treatment. The mean is an overall mean of all the recordings in all patients, one mean value per treatment group." (NCT01213836)
Timeframe: Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.

Interventionunits on a scale (Mean)
Seroquel XR2.4
Seroquel IR2.6

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Mean Ratio of Morning Plasma Concentration of Quetiapine and Nor-quetiapine for Quetiapine IR and Quetiapine XR, at Steady-state Conditions in the End of Each Treatment Period 1 and 2.

The ratio was derived as individual plasma concentration of quetiapine divided by the plasma concentration of nor-quetiapine. The mean ratio was derived for each treatment, XR and IR, respectively. (NCT01213836)
Timeframe: End of Period 1, end of Period 2

InterventionRatio (Mean)
Seroquel XR1.941
Seroquel IR2.128

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Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving

International Shopping List Task (ISLT): measures reasoning and problem solving. Min=minus infinity, max=plus infinity, higher score=better performance. Groton Maze Learning Test (GMLT): measures reasoning and problem solving. Min=minus infinity, max=plus infinity, lower score=better performance. Lower=better performance. One Back memory task (ONB: measures working memory, min=minus infinity, max=plus infinity, lower score=better performance. (NCT01213836)
Timeframe: Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.

,
InterventionUnits on a scale (Mean)
ISLT post 1ISLT post 2ISLT post 3GMLT post 1GMLT post 2GMLT post 3ONB post 1ONB post 2ONB post 3
Seroquel IR23.58823.15222.92061.04056.95657.3002.8972.8962.893
Seroquel XR24.02023.55123.21664.18059.02157.2292.8752.8962.894

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Montgomery Asberg Depression Rating Scale (MADRS)

For MDD: The primary efficacy measures will be change from baseline to endpoint in the MADRS and the change in mean daily benzodiazepine dose in diazepam equivalents during the past week. Range is 0 (least severe) to 50 (most severe). (NCT01244711)
Timeframe: 12 weeks

Interventionunits on a scale (Number)
Quetiapine-12

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The Changes From Baseline in Young Mania Rating Scale (YMRS) Total Score to Day 29

The Young Mania Rating Scale (YMRS) is an eleven-item, multiple-choice diagnostic questionnaire which psychiatrists use to measure the severity of manic episodes. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. Total score is summed of 11items. Total score rage is from 0 to 60 and the higher score represent a worse oucome. (NCT01254721)
Timeframe: From Baseline to Day 29

Interventionscores on the scale (Mean)
Seroquel XR-13.7
Seroquel XR + Lithium-15.5

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The Change From Baseline up to Day 29 and Final Assessment in the Clinical Global Impression-Severity of Illness Scale (CGI-S)

"The Severity of Illness scale (CGI-S) is scored to rate the patient's current clinical state. The score range is form 0 to 7. A CGI-S score of 1 indicates that a patient is Normal, not at all ill and a score of 7 indicates that a patient is Among the most extremely ill patients." (NCT01254721)
Timeframe: From Baseline to Day 29

Interventionscores on the scale (Mean)
Seroquel XR-1.37
Seroquel XR + Lithium-1.58

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"The Proportion of Patients at Week 8 With a Clinical Global Impression - Bipolar - Change (CGI-BP-C) of Much or Very Much Improved"

"Clinical Global Impression - Bipolar - Change (CGI-BP-C) of much or Very much improved is defined as a change in CGI-BP overall bipolar illness score ≤ 2 where 1 = very much improved, 2 = much improved." (NCT01256177)
Timeframe: After 8 weeks of start of treatment

InterventionParticipants (Number)
Placebo65
Quetiapine XR91

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Incidence of Treatment-emergent Mania (AE of Mania or Hypomania, Defined as Young Mania Rating Scale [YMRS] Score ≥16 on 2 Consecutive Assessments or Final Assessment)

The incidence of treatment-emergent mania is defined as ≥16 of YMRS total score on 2 consecutive assessments or at final assessment, YMRS total score range: 0-60, the higher is the total score the more severe is the disease. (NCT01256177)
Timeframe: After 8 weeks of start of treatment

InterventionParticipants (Number)
Placebo4
Quetiapine XR1

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Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment)

Montgomery-Asberg Depression Rating Scale (MADRS) total score range: 0 to 60, the higher the score, the more severe, Remission was defined as MADRS total score ≤12 (NCT01256177)
Timeframe: After 8 week of start of treatment

InterventionParticipants (Number)
Placebo59
Quetiapine XR88

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Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Response (Subjects With ≥50% Reduction From Baseline to Week 8 in MADRS Total Score)

Montgomery-Asberg Depression Rating Scale (MADRS) total score range: 0 to 60, the higher the score, the more severe, Response was defined as ≥50% reduction in MADRS total score from baseline (NCT01256177)
Timeframe: 8 weeks from baseline

InterventionParticipants (Number)
Placebo62
Quetiapine XR93

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Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

MADRS total score range: 0 to 60, the higher the score, the more severe, Change : Total MADRS score at week 8 minus score at baseline (NCT01256177)
Timeframe: Baseline to Week 8

,
InterventionScores on a scale (Least Squares Mean)
Change from Baseline to End of StudyBaseline
Placebo-15.2728.8
Quetiapine XR-18.4828.5

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Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar - Severity (CGI-BP-S)

CGI-BP severity of illness-Overall bipolar range = 1-7, the higher is the total score,the more severe is the disease. CGI-BP severity of illness-Depression range: 1-7, the higher is the total score, the more severe is the disease (NCT01256177)
Timeframe: Baseline to Week 8

,
InterventionScores on a scale (Least Squares Mean)
CGI-BP-S score for Overall Bipolar (BP) IllnessCGI-BP-S score of depressionCGI-BP-S overall score BaselineCGI-BP-S score for depression Baseline
Placebo-1.73-1.814.54.5
Quetiapine XR-2.24-2.284.64.6

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Change From Baseline to Week 8 in HAM-D Total Scores

HAM-D total score range: 0 to 53, the higher the score, the more severe. Change : Total HAM-D score at week 8 minus score at baseline (NCT01256177)
Timeframe: Baseline to Week 8

,
InterventionScores on a scale (Least Squares Mean)
Change from Baseline to Week 8Baseline
Placebo-12.9223.2
Quetiapine XR-15.1623.5

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Change From Baseline to Week 8 in Item 10 of Montgomery-Asberg Depression Rating Scale (MADRS) for Suicidal Ideation

MADRS item 10 (suicidal ideation) score range: 0 to 6, the higher the score, the more severe, Change: MADRS item 10 score at week 8 minus score at baseline (NCT01256177)
Timeframe: Baseline to Week 8

,
InterventionScores on a scale (Least Squares Mean)
Change from Baseline to Week 8Baseline
Placebo-0.761.2
Quetiapine XR-0.981.0

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Change From Baseline to Each Assessment in MADRS Total Score

MADRS total score range: 0 to 60, the higher the score, the more severe. (NCT01256177)
Timeframe: Baseline to Week 8

,
InterventionScores on a scale (Least Squares Mean)
Change from Baseline to Week 1Change from Baseline to Week 2Change from Baseline to Week 4Change from Baseline to Week 6Change from Baseline to Week 8Baseline
Placebo-4.14-7.70-11.05-13.96-15.2728.8
Quetiapine XR-5.62-10.13-14.18-16.04-18.4828.5

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Necessary Clinical Adjustments

Necessary Clinical Adjustment (NCA): The Medication Recommendation Tracking Form was developed and successfully implemented in a previous study to capture recommended medication changes at each study visit 17. Clinicians record dosage changes, missed doses, new medications added or discontinued, and specify the reason for each change. Any change in psychotropic medications, or medications used to treat side effects, is coded along with the reason for the change. NCAs include those changes made for lack of effectiveness or intolerance, but not changes for planned dose titrations. (NCT01331304)
Timeframe: 6 Months

InterventionMean NCAs per month (Mean)
Li + APT.8
QTP + APT.9

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Longitudinal Interval Follow up Evaluation Range of Impaired Functioning Tool (LIFE-RIFT)

The LIFE-RIFT asses the extent to which psychopathology has impacted current functioning in work, household chores, interpersonal relationships with partner, family, and friends, recreational activities, and life, satisfaction, leisure activities and social relationships. Summary scores can range from 4 to 20, with higher scores indicating greater functional impairment. (NCT01331304)
Timeframe: Average baseline score minus Average 6-month score

Interventionunits on a scale (Mean)
Li + APT-3.74
QTP + APT-3.61

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Clinical Global Impression-Efficacy Index (CGI-EI)

The CGI-EI integrates benefits and harms and yields a score that can be compared across interventions. It is made up of 2 subscales: therapeutic effects and side effects. Each rating is on a scale from 1 to 4. To combine these two subscales into the CGI-EI we report as our primary outcome, we subtracted the side effects subscale from the therapeutic effects subscale. Thus, the CGI-EI we report ranges the integers from -3 to +3 (i.e. possible scores are -3,-2,-1,0,1,2,3). A score of -3 is the most burdensome side effect score (4) and the least therapeutic effect score (1) and a score of +3 is the least burdensome side effect score (1) and the highest therapeutic effect score (4). Higher CGI-EI signifies better outcome (minimal side effects, maximal therapeutic effect). Lower CGI-EI signifies worse outcome (maximal side effects, minimal therapeutic effect).To compute CGI-EI score, we subtract the side effect score from the therapeutic effect score. (NCT01331304)
Timeframe: Average 6 month score minus Average baseline score

InterventionUnits on the scale (Mean)
Li + APT1.58
QTP + APT1.52

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Risk of Cardiovascular Disease - Framingham Risk Score

The Framingham risk score captures the classic risk factors for cardiovascular disease, including age, sex, systolic blood pressure, total and high density lipoprotein cholesterol, diabetes mellitus, and smoking. The Framingham risk score is used as a simple predictive tool to determine 10-year (short term) risk for developing cardiovascular disease (CHD), with higher scores indicating higher risk. Established benchmarks exist for scores from 0 to 25--though it can exceed this value--that are meant to translate to the probability of developing heart disease. (NCT01331304)
Timeframe: Average baseline score minus Average 6 month score

Interventionunits on a scale (Mean)
Li + APT-0.26
QTP + APT0.17

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Time to Study Discontinuation

The time, as measured in number of days, for discontinuation due to all causes will be measured and used as the primary outcome measure (NCT01526148)
Timeframe: Week 16

Interventiondays (Mean)
Lithium41
Quetiapine77

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Lithium vs. Quetiapine Effects on General Cardiovascular Disease Risk as Measured by Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

Change in homeostatic model assessment for insulin resistance (HOMA-IR) from screening to end of study. Insulin resistance is a condition in which cells fail to respond to the normal actions of the hormone in the body. The HOMA-IR is calculated using a subject's fasting plasma insulin and glucose levels. The higher the score, the higher the level of insulin resistance. (NCT01526148)
Timeframe: Screening and Week 16

InterventionIR Score (Mean)
Lithium-5.5
Quetiapine0.2

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Demographic in Randomization 1 Group

Baseline demographic percentages of subject randomized to either Divalproex or Lithium at the first randomization (NCT01588457)
Timeframe: Baseline

,
Interventionpercentage of subjects (Number)
Single never marriedMarriedDisrupted Marriage
Divalproex27.155.917.0
Lithium33.337.029.6

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Baseline Randomization Percentage of Bipolar Types

Percentages of Type I and Type II Bipolar Disorder included in Randomization groups (NCT01588457)
Timeframe: Baseline

Interventionpercentage of participants (Number)
Bipolar Type 1 Divalproex Group70
Bipolar Type II Divalproex Group74.1
Bipolar Type 1 Lithium Group30
Bipolar Type II Lithium Group25.9

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Bipolar Inventory of Symptoms Scale (BISS)

"The BISS uses a structured interview to assess the full spectrum of symptoms associated with all primary clinical states in bipolar disorder, yielding a total severity, a depression, a mania, as well as dimensional scale scores. There are 42 items; each item is rated on a 0-4 scale. The BISS is a clinician-rated instrument. The Scale is rated as follows:~0 Not at all~Slight~Mild~Moderate~Severe Each of the 42 items is rated separately, with a score, based on the most recent 7 day period. The mean score is calculated from the total score, giving an overall score out of 4, where 0 is slight and 4 is the most severe symptoms. A negative score indicated an improvement from baseline to 26 weeks." (NCT01588457)
Timeframe: Change from Baseline to 26 weeks

,,,,
Interventioncalculated mean scale score (Mean)
ManiaDepressionIrritabilityAnxietyPsychosis
Divalproex After Randomization 1-0.31-0.71-0.50-0.49-0.14
Divalproex or Lithium Monotherapy0.15-0.18-0.270.16-0.27
Lithium After Randomization 1-0.41-0.20-0.39-0.51-0.25
Lithium or Divalproex Plus Lamotrigine-0.85-0.95-0.96-0.93-0.16
Lithium or Divalproex Plus Quetiapine-0.38-0.61-0.66-0.72-0.14

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Global Assessment of Functioning

"The Clinical Global Impression-Severity Scale (CGI-S) is used to assess global illness severity~The CGI-S score change is measured from baseline to 26 weeks and is rated on a 7-point scale. The scale is read as follows:~very much improved since the initiation of treatment~much improved~minimally improved~no change from baseline (the initiation of treatment)~minimally worse~much worse~very much worse since the initiation of treatment The score is calculated as a mean of all items, where 1 indicates improvement from inititation of visit, and 7 indicates the condition to be much worse since the inititation of treatment. A negative score indicates a change from worse to better." (NCT01588457)
Timeframe: Change from Baseline to 26 weeks

,,,,
Interventioncalculated mean scale score (Mean)
CGI-DepressionCGI-ManiaCGI-Overall
Divalproex After Randomization 1-1.11-0.69-1.28
Divalproex or Lithium Monotherapy-0.09-0.19-0.11
Lithium After Randomization 1-0.32-1.12-0.55
Lithium or Divalproex Plus Lamotrigine-1.24-1.81-1.64
Lithium or Divalproex Plus Quetiapine-0.99-0.71-0.99

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Change in Insomnia Severity Index (ISI) Scores

THE RANGE OF SCORES IS FROM 0-28, WITH 28 REPRESENTING SEVERE INSOMNIA SYMPTOMS. Measurements made and reported at baseline, week 2, week 4. Data will be presented and analyzed for those time points with the main outcome measured as the change from baseline to week 4. . This is a comparison between groups (trazodone versus quetiapine)of the change on TOTAL ISI scores over time using repeated measures analysis. This is a non-superiority analysis, so the hypothesis is that there is no significant difference between treatments. The investigators will first report the comparison during the active treatment phase (baseline to end of week 4) as the main comparison, but will also examine and report changes on the outcome at the follow up point (end of week 8). (NCT01662297)
Timeframe: from baseline (week 0) to the end of week 4 and at week 8

Interventionunits on a scale (Mean)
change at week 4change at week 8
Trazodone-14-16

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Change in RAND Short Form 36 Item Health Survey (RAND-SF36) General Health Subscale Over Time

Scores range from 0-100 representing percentage, with a higher score representing better functioning. Measurements made at baseline, week 2, week 4, week 8. Data will be presented and analyzed for those time points with the main outcome measured as the change from baseline to week 4. The change from week 4 to week 8 (post-intervention) will also be measured and analyzed, reported. This is a comparison between groups (trazodone versus quetiapine)of the change on RAND-SF36 scores over time. This is a non-superiority analysis, so the hypothesis is that there is no significant difference between treatments. The investigators will first report the comparison during the active treatment phase (baseline to end of week 4) as the main comparison, but will also examine and report changes on the outcome at the follow up point (end of week 8). (NCT01662297)
Timeframe: from week 0 (baseline) to end of week 8

Interventionpercentage of total points possible (Mean)
change at week 4change at week 8
Trazodone150

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Medical Outcomes Study Sleep Scale- Sleep Index (Short)

THE RANGE OF SCORES IS FROM 0-100, WITH 100 REPRESENTING SEVERE INSOMNIA SYMPTOMS. Measurements made and reported at baseline, week 2, week 4. Data will be presented and analyzed for those time points with the main outcome measured as the change from baseline to week 4. . This is a comparison between groups (trazodone versus quetiapine)of the change on TOTAL MOS-SS scores over time using repeated measures analysis. This is a non-superiority analysis, so the hypothesis is that there is no significant difference between treatments. The investigators will first report the comparison during the active treatment phase (baseline to end of week 4) as the main comparison, but will also examine and report changes on the outcome at the follow up point (end of week 8). (NCT01662297)
Timeframe: from baseline (week 0) to the end of week 8 sample

Interventionunits on a scale (Mean)
change at 4 weekschange at 8 weeks
Trazodone-13.33-26.66

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Percentage of Heavy Drinking Days

This is a comparison between groups of the mean percent heavy drinking days during the first 4 weeks, and then through to the follow up point (end of week 8). The investigators will first report the comparison during the active treatment phase (baseline to end of week 4) as the main comparison, but will also examine and report changes on the outcome at the follow up point (end of week 8). (NCT01662297)
Timeframe: from week 0 (baseline) to end of week 8

Interventionpercentage of heavy drinking days (Mean)
percentage at week 4percentage at week 8
Trazodone00

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Percentage of Negative Urine Drug Screens

This is a comparison between groups of the mean percent of negative urine drug screens. The investigators will first report the comparison during the active treatment phase (baseline to end of week 4) as the main comparison, but will also examine and report changes on the outcome at the follow up point (end of week 8). THIS IS A CUMULATIVE PERCENTAGE. MAXIMUM SCORE IS 100%, MINIMUM 0%. (NCT01662297)
Timeframe: from week 0 (baseline) to end of week 8

Interventionpercentage of tests (Mean)
cumulative percentage at week 4cumulative percentage at week 8
Trazodone00

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Change in Alcohol Urge Questionnaire (AUQ)Scores Over Time

The lowest possible score for the AUQ is 8 (representing less urge to drink) and the highest score would be a 56 (more urge to drink). Measurements made at baseline, week 2, week 4, week 8. Data will be presented and analyzed for those time points with the main outcome measured as the change from baseline to week 4. This is a comparison between groups (trazodone versus quetiapine)of the change on AUQ scores over time. This is a non-superiority analysis, so the hypothesis is that there is no significant difference between treatments. The investigators will first report the comparison during the active treatment phase (baseline to end of week 4) as the main comparison, but will also examine and report changes on the outcome at the follow up point (end of week 8). (NCT01662297)
Timeframe: from week 0 (baseline) to end of week 8

Interventionunits on a scale (Mean)
change after week 4change after week 8
Trazodone-1-12

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Change in Average Pittsburgh Sleep Quality Inventory (PSQI)Score

Data analyzed for change from score at baseline, to week 4, to week 8. The range of scores is 0-21 on this scale, with higher scores indicating worse sleep quality. Data will be presented and analyzed for those time points with the main outcome measured as the change from baseline to week 4. This is a comparison between groups (trazodone versus quetiapine)of the change on TOTAL PSQI scores over time using repeated measures analysis. This is a non-superiority analysis, so the hypothesis is that there is no significant difference between treatments. The first four weeks of treatment is the active acute experiment phase, and this will be the main comparison time period for the endpoint, but the investigators will also analyze change in PSQI until the follow-up point at the end of week 8. (NCT01662297)
Timeframe: From baseline (week 0) to end of 4 week and end of week 8

Interventionunits on a scale (Mean)
change at week 4change at week 8
Trazodone-11-11

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Change in Brief Symptom Inventory (BSI) Over Time

The Brief Symptom Inventory scale measures a broad range of psychiatric symptoms (psychological distress) and is meant to provide an overall measure of mental health symptomatology. The BSI has 53 items that use a 5-item Likert scale response. In general, higher scores correspond to greater symptomatology and distress. Usually, the range of scores goes from 0 - 4, since it is averaged over the number of responses, however, we report the raw total score which is the sum of all responses, thus the range is 0-212. Measurements made at baseline, week 2, week 4, week 8. Data will be presented and analyzed for those time points with the main outcome measured as the change from baseline to week 4. This is a comparison between groups of the change on BSI scores over time using repeated measures analysis. This is a non-superiority analysis, so the hypothesis is that there is no significant difference between treatments. (NCT01662297)
Timeframe: from week 0 (baseline) to end of week 8

Interventionunits on a scale (Mean)
change at week 4change at week 8
Trazodone-48-48

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Change in Epworth Sleepiness Scale (ESS) Over Time

Measurements made at baseline, week 2, week 4, week 8. Data will be presented and analyzed for those time points with the main outcome measured as the change from baseline to week 4. The change from week 4 to week 8 (post-intervention) will also be measured and analyzed, reported. This is a comparison between groups (trazodone versus quetiapine)of the change on ESS scores over time using repeated measures analysis. This is a non-superiority analysis, so the hypothesis is that there is no significant difference between treatments. The investigators will first report the comparison during the active treatment phase (baseline to end of week 4) as the main comparison, but will also examine and report changes on the outcome at the follow up point (end of week 8).The minimum score on ESS is 0-24 units, with higher score representing greater sleepiness. (NCT01662297)
Timeframe: From baseline (week 0) to end of week 8

Interventionunits on a scale (Mean)
change at week 4change at week 8
Trazodone-3-4

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Marijuana Use, Daily Dollar Averaged Over 7 Days During Each of 12 Weeks of Study

The median daily dollar value of marijuana used averaged over a one-week period for each of the 12 weeks as recorded by the Timeline Followback method (NCT01697709)
Timeframe: 12 weeks or length of participants involvement

,
Interventiondollars (Median)
week 1week 2week 3week 4week 5week 6week 7week 8week 9week 10week 11week 12
Placebo14.0010.007.146.436.435.713.702.866.435.353.211.00
Quetiapine7.008.005.865.714.294.113.573.433.002.862.862.14

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Number of Participants Stratified by Marijuana Abstinence Days Per Week

The number of abstinent days per week over the 12 weeks of study as recorded by the Timeline Followback method. High Use group defined as 0-2 abstinent days per week, Medium Use Group as 3-5 abstinent days per week and Low Use Group as 6-7 abstinent days per week. (NCT01697709)
Timeframe: 12 weeks or length of participation

InterventionParticipants (Count of Participants)
Week 172079520Week 172079519Week 272079519Week 272079520Week 372079519Week 372079520Week 472079519Week 472079520Week 572079520Week 572079519Week 672079520Week 672079519Week 772079519Week 772079520Week 872079519Week 872079520Week 972079519Week 972079520Week 1072079520Week 1072079519Week 1172079519Week 1172079520Week 1272079519Week 1272079520
high usemedium uselow use
Quetiapine4
Placebo9
Quetiapine9
Placebo40
Quetiapine46
Placebo8
Placebo7
Quetiapine7
Placebo34
Quetiapine44
Quetiapine5
Placebo28
Quetiapine33
Quetiapine8
Placebo23
Quetiapine26
Placebo10
Quetiapine10
Quetiapine16
Placebo22
Quetiapine21
Placebo13
Placebo4
Quetiapine13
Quetiapine23
Placebo12
Quetiapine11
Quetiapine15
Quetiapine17
Placebo18
Placebo14
Placebo15
Quetiapine14
Placebo5
Quetiapine12
Placebo16
Placebo17
Placebo3

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Change From Baseline in Pittsburgh Sleep Quality Index (PSQI)

"The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval. Nineteen individual items generate seven component scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction, each on a scale from 0 (best) to 3 (worst). The sum of scores for these seven components yields one global score, ranging from 0 to 21, with higher scores indicative of poor sleep quality." (NCT01725282)
Timeframe: Baseline and Week 6

Interventionunits on a scale (Mean)
Placebo-1.1
Quetiapine 50 mg-1.8
Quetiapine 150 mg-1.5
Quetiapine 300 mg-1.8

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Percentage of Participants With Improvement in Clinical Global Impressions-Improvement (CGI-I)

"The Clinical Global Impression - global improvement assesses the participant's improvement (or worsening) as assessed by the clinician relative to Baseline on a 7-point scale: 1, markedly improved; 2, moderately improved; 3, minimally improved; 4, no change; 5, minimally worsened; 6, moderately worsened; or 7, markedly worsened.~Improvement is defined as a score of 1 or 2." (NCT01725282)
Timeframe: Baseline and Week 6

Interventionpercentage of participants (Number)
Placebo54.5
Quetiapine 50 mg50.0
Quetiapine 150 mg53.7
Quetiapine 300 mg27.2

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Change From Baseline in Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)

"The Medical Outcomes Study SF-36 is a participant self-rated questionnaire that is a general measure of perceived health status comprising 36 questions, which yields an 8-scale health profile. The 8 health concepts are:~Limitation in physical activities because of health problems.~Limitations in usual role activities because of physical health problems.~Bodily pain.~Limitations in social activities because of physical or emotional problems.~General mental health (psychological distress and well-being).~Limitations in usual role activities because of emotional problems.~Vitality (energy and fatigue).~General health perception.~Each scale ranges from 0 to 100, with 0 indicating the least favorable status and 100 being the most favorable health status." (NCT01725282)
Timeframe: Baseline and Week 6

,,,
Interventionunits on a scale (Mean)
Physical FunctioningRole Limitations - PhysicalBodily painGeneral Health PerceptionVitalitySocial FunctioningRole Limitations - EmotionalMental Health
Placebo2.88.84.46.37.57.19.82.5
Quetiapine 150 mg0.47.42.54.76.77.411.88.1
Quetiapine 300 mg1.46.1-0.58.79.26.09.77.5
Quetiapine 50 mg1.41.111.26.08.16.513.89.7

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Safety Assessed by the Incidence of Adverse Events (AE), Vital Signs, Electrocardiogram (ECG) and Laboratory Tests

An AE is defined as any untoward medical occurrence in a patient administered a study drug, and which does not necessarily have a causal relationship with this treatment. Abnormal laboratory parameters, vital signs or ECG data were defined as AEs if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. A serious AE was an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs were assessed by the Investigator for intensity as mild, moderate or severe and for causal relationship to study drug. (NCT01725282)
Timeframe: Up to 8 weeks

,,,
Interventionparticipants (Number)
Any adverse eventDrug-related adverse eventDeathsSerious adverse eventDrug-related serious adverse eventAE leading to discontinuationDrug-related AE leading to discontinuation
Placebo252100021
Quetiapine 150 mg352900066
Quetiapine 300 mg353101142
Quetiapine 50 mg332401122

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Change From Baseline in Hamilton Rating Score for Depression (HAM-D17)

The 17-item Hamilton Depression Scale (HAM-D17) is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score range is from 0 to 52 where a higher score indicates a greater depressive state. (NCT01725282)
Timeframe: Baseline and Week 6

Interventionunits on a scale (Mean)
Placebo-10.1
Quetiapine 50 mg-9.3
Quetiapine 150 mg-10.2
Quetiapine 300 mg-8.7

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Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

The Montgomery Åsberg Depression Rating Scale (MADRS) is a depression rating scale consisting of 10 items, each rated 0 to 6. The 10 items represent the core symptoms of depressive illness. The overall score ranges from 0 (symptoms absent) to 60 (severe depression). Decrease in the total score or on individual items indicates improvement. (NCT01725282)
Timeframe: Baseline and Week 6

Interventionunits on a scale (Least Squares Mean)
Placebo-11.5
Quetiapine 50 mg-11.3
Quetiapine 150 mg-12.1
Quetiapine 300 mg-10.3

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

InterventionParticipants (Count of Participants)
Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
Placebo / FK949E1796546233316

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Change From Baseline in Young Mania Rating Scale (YMRS) (Treatment Period I)

"The YMRS is a scale used to evaluate manic symptoms. The YMRS total score was the total assessment of assessed points for 11 items, ranges from 0 to 60 (each item is scored from either 0-4 or 0-8 by severity (0 = absent and 4/8 = displays mood/behavior to a greater degree). A lower score indicates Absent or Normal." (NCT01725308)
Timeframe: Baseline and Weeks 1, 2, 3, 4, 6, 8

,,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4Week 6Week 8End of Treatment Period 1
FK949E 150 mg-0.6-1.0-1.2-1.3-1.4-1.7-1.6
FK949E 300 mg-0.6-0.7-0.7-0.9-0.8-0.9-0.8
Placebo-0.1-0.2-0.1-0.4-0.3-0.4-0.2

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Change From Baseline in YMRS (Combined Treatment Period I and II)

"The YMRS is a scale used to evaluate manic symptoms. The YMRS total score was the total assessment of assessed points for 11 items, ranges from 0 to 60 (each item is scored from either 0-4 or 0-8 by severity (0 = absent and 4/8 = displays mood/behavior to a greater degree). A lower score indicates Absent or Normal. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12." (NCT01725308)
Timeframe: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52

,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4Week 6Week 8Week 10Week 12Week 13Week 14Week 16Week 18Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
FK949E 150 mg / FK949E-0.6-1.0-1.2-1.3-1.4-1.7-1.6-1.2-1.3-1.6-1.3-1.6-1.5-1.4-1.6-1.4-1.3-1.6-1.7-1.9-1.9-1.6
FK949E 300 mg / FK949E-0.6-0.7-0.7-0.9-0.8-0.9-0.8-1.0-1.1-1.1-0.9-1.1-0.9-0.9-1.1-0.3-0.9-1.0-1.1-1.3-1.2-0.4

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Change From Baseline in YMRS (Combined Treatment Period I and II)

"The YMRS is a scale used to evaluate manic symptoms. The YMRS total score was the total assessment of assessed points for 11 items, ranges from 0 to 60 (each item is scored from either 0-4 or 0-8 by severity (0 = absent and 4/8 = displays mood/behavior to a greater degree). A lower score indicates Absent or Normal. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12." (NCT01725308)
Timeframe: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52

Interventionunits on a scale (Mean)
Week 13Week 14Week 16Week 18Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
Placebo / FK949E-0.3-0.4-0.5-0.7-0.5-0.6-0.7-0.7-0.7-0.8-0.5-0.7-0.8-0.5

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Change From Baseline in MADRS Total Score (Treatment Period I)

The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. (NCT01725308)
Timeframe: Baseline and Weeks 1, 2, 3, 4, 6, 8

,,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4Week 6Week 8
FK949E 150 mg-6.4-10.0-11.6-12.5-14.5-14.4
FK949E 300 mg-5.1-8.3-9.9-11.8-12.2-12.6
Placebo-3.5-5.1-7.1-8.5-9.2-10.1

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Change From Baseline in MADRS Total Score (Combined Treatment Period I and II)

The MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. (NCT01725308)
Timeframe: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52

,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4Week 6Week 8Week 10Week 12Week 13Week 14Week 16Week 18Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
FK949E 150 mg / FK949E-6.4-10.0-12.0-13.1-15.6-15.8-16.3-16.4-18.1-17.0-17.1-17.3-18.7-21.4-22.9-22.3-23.1-23.3-23.4-24.1-24.4-16.0
FK949E 300 mg / FK949E-5.1-8.5-10.6-13.2-13.8-14.8-15.9-16.0-13.3-16.4-17.2-19.0-18.2-18.4-19.4-19.4-19.4-19.8-20.7-20.9-22.1-15.2

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Change From Baseline in MADRS Total Score (Combined Treatment Period I and II)

The MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. (NCT01725308)
Timeframe: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52

Interventionunits on a scale (Mean)
Week 13Week 14Week 16Week 18Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
Placebo / FK949E-1.6-3.1-4.3-6.8-6.8-7.1-7.0-6.6-7.5-8.2-8.1-7.6-7.8-6.6

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Clinical Global Impression-Bipolar Disorder-Change (CGI-BP-C): Mania (Treatment Period I)

The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. (NCT01725308)
Timeframe: Weeks 1, 2, 3, 4, 6, 8

,,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4Week 6Week 8
FK949E 150 mg4.04.04.04.03.93.9
FK949E 300 mg4.04.04.04.04.04.0
Placebo4.04.04.04.04.04.0

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Change From Baseline in Hamilton Depression Rating Scale (HAM-D17) Total Score (Treatment Period I)

The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. (NCT01725308)
Timeframe: Baseline and Weeks 1, 2, 3, 4, 6, 8

,,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4Week 6Week 8
FK949E 150 mg-5.9-8.7-10.0-10.9-11.9-11.9
FK949E 300 mg-4.5-7.0-7.9-9.2-9.6-10.1
Placebo-3.4-5.1-6.6-7.3-7.7-8.4

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Change From Baseline in HAM-D17 (Combined Treatment Period I and II)

The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. (NCT01725308)
Timeframe: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 28, 36, 40, 44, 52

Interventionunits on a scale (Mean)
Week 14Week 16Week 20Week 28Week 36Week 44Week 52End of combined treatment period
Placebo / FK949E-1.9-2.9-4.2-4.8-4.9-5.7-5.6-4.6

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Change From Baseline in HAM-D17 (Combined Treatment Period I and II)

The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. (NCT01725308)
Timeframe: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 28, 36, 40, 44, 52

,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4Week 6Week 8Week 10Week 12Week 14Week 16Week 20Week 28Week 36Week 44Week 52End of combined treatment period
FK949E 150 mg / FK949E-5.9-8.8-10.3-11.4-12.7-13.0-13.1-13.7-13.9-13.7-14.6-16.7-17.1-17.0-17.8-12.9
FK949E 300 mg / FK949E-4.5-7.1-8.4-9.9-10.7-11.6-12.4-12.6-12.8-13.4-13.8-14.3-14.6-15.1-16.2-11.6

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Change From Baseline in Drug Induced Extra-Pyramidal Symptoms Scale (DIEPSS): Total Score (Treatment Period I)

"The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as normal. The DIEPSS total score ranges from 0 (none, normal) to 32 (severe), and excludes the global assessment of severity." (NCT01725308)
Timeframe: Baseline and Weeks 4, 8

,,
Interventionunits on a scale (Mean)
Week 4Week 8End of Treatment Period I
FK949E 150 mg0.00.00.0
Placebo0.00.10.1
Treatment Period I: FK949E 300 mg0.20.10.1

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Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II)

"The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as normal. The DIEPSS total score ranges from 0 (none, normal) to 32 (severe), and excludes the global assessment of severity. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12." (NCT01725308)
Timeframe: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 52

Interventionunits on a scale (Mean)
Week 16Week 20Week 28Week 36Week 44Week 52End of combined treatment period
Placebo / FK949E0.20.10.10.00.00.10.1

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Change From Baseline in DIEPSS: Total Score (Combined Treatment Period I and II)

"The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as normal. The DIEPSS total score ranges from 0 (none, normal) to 32 (severe), and excludes the global assessment of severity. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12." (NCT01725308)
Timeframe: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 52

,
Interventionunits on a scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 28Week 36Week 44Week 52End of combined treatment period
FK949E 150 mg / FK949E0.00.00.10.10.1-0.00.0-0.00.0-0.0
FK949E 300 mg / FK949E0.20.10.10.10.10.0-0.1-0.1-0.20.0

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Change From Baseline in DIEPSS: Parkinsonism (Treatment Period I)

"The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as normal. Parkinsonism is a total of the gait disturbance, bradykinesia, salivation, muscle rigidity, and tremor scores and ranges from 0 (none, normal) to 20 (severe)." (NCT01725308)
Timeframe: Baseline and Weeks 4, 8

,,
Interventionunits on a scale (Mean)
Week 4Week 8End of Treatment Period I
FK949E 150 mg-0.1-0.1-0.1
FK949E 300 mg0.0-0.1-0.1
Placebo0.00.00.1

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Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II)

"The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as normal. Parkinsonism is a total of the gait disturbance, bradykinesia, salivation, muscle rigidity, and tremor scores and ranges from 0 (none, normal) to 20 (severe). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12." (NCT01725308)
Timeframe: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 52

Interventionumits on a scale (Mean)
Week 16Week 20Week 28Week 36Week 44Week 52End of combined treatment period
Placebo / FK949E0.00.0-0.0-0.1-0.0-0.0-0.0

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Change From Baseline in DIEPSS: Parkinsonism (Combined Treatment Period I and II)

"The DIEPSS is a scale used to evaluate drug-induced extrapyramidal symptoms. DIEPSS is composed of 8 individual symptom parameters and a global assessment of severity, each rated on a 5-point scale, with lower scores indicating as normal. Parkinsonism is a total of the gait disturbance, bradykinesia, salivation, muscle rigidity, and tremor scores and ranges from 0 (none, normal) to 20 (severe). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12." (NCT01725308)
Timeframe: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 4, 8, 12, 16, 20, 28, 36, 44, 52

,
Interventionumits on a scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 28Week 36Week 44Week 52End of combined treatment period
FK949E 150 mg / FK949E-0.1-0.10.0-0.0-0.0-0.1-0.1-0.1-0.1-0.1
FK949E 300 mg / FK949E0.0-0.1-0.1-0.1-0.1-0.1-0.1-0.1-0.2-0.1

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Change From Baseline in Clinical Global Impression-Bipolar Disorder-Severity (CGI-BP-S): Mania (Treatment Period I)

The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). (NCT01725308)
Timeframe: Baseline and Weeks 1, 2, 3, 4, 6, 8

,,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4Week 6Week 8
FK949E 150 mg0.0-0.0-0.0-0.0-0.1-0.1
FK949E 300 mg0.00.00.00.00.00.0
Placebo-0.0-0.00.00.00.00.0

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

InterventionParticipants (Count of Participants)
Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
Placebo / FK949E000000000000

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Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Treatment Period I)

The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician with the scale from 1 (not ill) to 7 (very severely ill). (NCT01725308)
Timeframe: Baseline and Weeks 1, 2, 3, 4, 6, 8

,,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4Week 6Week 8
FK949E 150 mg-0.4-0.7-0.9-1.1-1.2-1.4
FK949E 300 mg-0.4-0.7-0.9-1.1-1.1-1.2
Placebo-0.3-0.5-0.7-0.8-0.8-1.0

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Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II)

The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. (NCT01725308)
Timeframe: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52

,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4Week 6Week 8Week 10Week 12Week 14Week 16Week 18Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
FK949E 150 mg / FK949E-0.4-0.7-0.9-1.1-1.3-1.4-1.4-1.4-1.4-1.6-1.6-1.7-2.0-2.2-2.2-2.4-2.3-2.2-2.4-2.6-1.7
FK949E 300 mg / FK949E-0.4-0.7-1.0-1.2-1.3-1.5-1.6-1.7-1.6-1.7-1.9-1.9-1.9-1.9-2.0-2.0-2.1-2.2-2.3-2.4-1.5

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Change From Baseline in CGI-BP-S: Overall Bipolar Illness (Combined Treatment Period I and II)

The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. (NCT01725308)
Timeframe: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52

Interventionunits on a scale (Mean)
Week 14Week 16Week 18Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
Placebo / FK949E-0.3-0.5-0.7-0.8-0.8-0.9-0.8-0.9-1.0-1.0-0.9-1.0-0.8

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Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II)

The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. (NCT01725308)
Timeframe: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52

,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4Week 6Week 8Week 10Week 12Week 14Week 16Week 18Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
FK949E 150 mg / FK949E0.00.0-0.00.0-0.0-0.0-0.00.0-0.1-0.1-0.1-0.1-0.0-0.00.0-0.00.0-0.0-0.0-0.0-0.1
FK949E 300 mg / FK949E0.0-0.00.00.00.0-0.00.0-0.0-0.0-0.0-0.0-0.00.00.00.0-0.00.0-0.00.0-0.00.1

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Change From Baseline in CGI-BP-S: Mania (Combined Treatment Period I and II)

The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. (NCT01725308)
Timeframe: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52

Interventionunits on a scale (Mean)
Week 14Week 16Week 18Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
Placebo / FK949E-0.0-0.0-0.0-0.0-0.0-0.0-0.0-0.0-0.0-0.0-0.0-0.0-0.0

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Number of Participants With MADRS Response (Treatment Period I)

A MADRS response was defined as a decrease in MADRS total score of 50% or more from baseline. The MADRS is a10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. (NCT01725308)
Timeframe: Baseline and Weeks 1, 2, 3, 4, 6, 8

,,
InterventionParticipants (Count of Participants)
Week 1Week 2Week 3Week 4Week 6Week 8
FK949E 150 mg61725283432
FK949E 300 mg154152627079
Placebo41336475463

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Number of Participants With MADRS Response (Combined Treatment Period I and II)

A MADRS response was defined as a decrease in MADRS total score of 50% or more from baseline. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. (NCT01725308)
Timeframe: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52

,
InterventionParticipants (Count of Participants)
Week 1Week 2Week 3Week 4Week 6Week 8Week 10Week 12Week 13Week 14Week 16Week 18Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
FK949E 300 mg / FK949E15374958667371686566677873747165616261575789
FK949E 150 mg / FK949E6162325302728223230263030313431302828292742

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Number of Participants With MADRS Response (Combined Treatment Period I and II)

A MADRS response was defined as a decrease in MADRS total score of 50% or more from baseline. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. (NCT01725308)
Timeframe: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52

InterventionParticipants (Count of Participants)
Week 13Week 14Week 16Week 18Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
Placebo / FK949E826314847484843434742384157

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Number of Participants With MADRS Remission (Treatment Period I)

MADRS remission was defined as MADRS total score of 12 or less. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. (NCT01725308)
Timeframe: Weeks 1, 2, 3, 4, 6, 8

,,
InterventionParticipants (Count of Participants)
Week 1Week 2Week 3Week 4Week 6Week 8
FK949E 150 mg41221212728
FK949E 300 mg122839496068
Placebo4926313947

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Number of Participants With MADRS Remission (Combined Treatment Period I and II)

MADRS remission was defined as MADRS total score of 12 or less. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52

,
InterventionParticipants (Count of Participants)
Week 1Week 2Week 3Week 4Week 6Week 8Week 10Week 12Week 13Week 14Week 16Week 18Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
FK949E 150 mg / FK949E4112019242524202424202324282828272624242638
FK949E 300 mg / FK949E12253645566161585860606864656458535554515182

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Number of Participants With MADRS Remission (Combined Treatment Period I and II)

MADRS remission was defined as MADRS total score of 12 or less. The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 1, 2, 3, 4, 6, 8, 10, 12, 13, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52

InterventionParticipants (Count of Participants)
Week 12Week 13Week 14Week 16Week 18Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
Placebo / FK949E414851526964676255566054555475

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Number of Participants With HAM-D17 Response (Treatment Period I)

A HAM-D17 response was defined as a decrease in HAM-D17 total score of 50% or more from baseline. The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. (NCT01725308)
Timeframe: Baseline and Weeks 1, 2, 3, 4, 6, 8

,,
InterventionParticipants (Count of Participants)
Week 1Week 2Week 3Week 4Week 6Week 8
FK949E 150 mg72230354441
FK949E 300 mg144252646678
Placebo102941546368

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Number of Participants With HAM-D17 Response (Combined Treatment Period I and II)

A HAM-D17 response was defined as a decrease in HAM-D17 total score of 50% or more from baseline. The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. (NCT01725308)
Timeframe: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 28, 36, 44, 52

InterventionParticipants (Count of Participants)
Week 14Week 16Week 20Week 28Week 36Week 44Week 52End of combined treatment period
Placebo / FK949E2030404436414053

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Number of Participants With HAM-D17 Response (Combined Treatment Period I and II)

A HAM-D17 response was defined as a decrease in HAM-D17 total score of 50% or more from baseline. The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52, where a higher score indicates a greater depressive state. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. (NCT01725308)
Timeframe: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 28, 36, 44, 52

,
InterventionParticipants (Count of Participants)
Week 1Week 2Week 3Week 4Week 6Week 8Week 10Week 12Week 14Week 16Week 20Week 28Week 36Week 44Week 52End of combined treatment period
FK949E 150 mg / FK949E7222732393535323530323229252543
FK949E 300 mg / FK949E14395061637377777880757361615895

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Number of Participants With an Affirmative Response to Columbia Suicide Severity Rating Scale (C-SSRS): Suicidal Ideation (Treatment Period I)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. (NCT01725308)
Timeframe: Weeks 4, 8

,,
Interventionparticipants (Number)
Week 4: Wish to be deadWeek 4: Suicidal thoughtsWeek 4: Suicidal thoughts w/ methodWeek 4: Suicidal intent (w/o plan)Week 4: Suicidal intent w/ planWeek 8: Wish to be deadWeek 8: Suicidal thoughtsWeek 8: Suicidal thoughts w/ methodWeek 8: Suicidal intent (w/o plan)Week 8: Suicidal intent w/ planEnd of Period I: Wish to be deadEnd of Period I: Suicidal thoughtsEndf of Period I: Suicidal thoughts w/ methodEnd of Period I: Suicidal intent (w/o plan)End of Period I: Suicidal intent w/ plan
FK949E 150 mg1430006200083000
FK949E 300 mg3410510152000269710
Placebo39104111963003213721

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Wish to be Dead (Combined Treatment Period I and II)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

,
InterventionParticipants (Count of Participants)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
FK949E 150 mg / FK949E1469885444434411
FK949E 300 mg / FK949E34152122128898677326

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Change From Baseline to End of Treatment Period I in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. (NCT01725308)
Timeframe: Baseline and Week 8

Interventionunits on a scale (Mean)
Placebo-10.1
FK949E 150 mg-14.4
FK949E 300 mg-12.6

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Change From Baseline in CGI-BP-S: Depression (Treatment Period I)

The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician with the scale from 1 (not ill) to 7 (very severely ill). (NCT01725308)
Timeframe: Baseline and Weeks 1, 2, 3, 4, 6, 8

,,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4Week 6Week 8
FK949E 150 mg-0.5-0.8-1.0-1.2-1.3-1.4
FK949E 300 mg-0.4-0.7-0.9-1.1-1.1-1.2
Placebo-0.3-0.5-0.7-0.8-0.9-1.0

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

InterventionParticipants (Count of Participants)
Week 12Week 16Week 32End of combined treatment period
Placebo / FK949E1112

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

InterventionParticipants (Count of Participants)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 36Week 40Week 48Week 52End of combined treatment period
FK949E 150 mg / FK949E000000002114

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts With Method (Combined Treatment Period I and II)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

InterventionParticipants (Count of Participants)
Week 4Week 8Week 12Week 16Week 24Week 28Week 36Week 40Week 44Week 48End of combined treatment period
FK949E 300 mg / FK949E500420200012

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

,
Interventionparticpants (Number)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
FK949E 150 mg / FK949E32222110120112
FK949E 300 mg / FK949E1021502202122014

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Thoughts (Combined Treatment Period I and II)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

Interventionparticpants (Number)
Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
Placebo / FK949E420000000002

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

InterventionParticipants (Count of Participants)
Week 12Week 16Week 32End of combined treatment period
Placebo / FK949E0112

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

InterventionParticipants (Count of Participants)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 36Week 40Week 48Week 52End of combined treatment period
FK949E 150 mg / FK949E000000000101

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent Without a Plan (Combined Treatment Period I and II)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

InterventionParticipants (Count of Participants)
Week 4Week 8Week 12Week 16Week 24Week 28Week 36Week 40Week 44Week 48End of combined treatment period
FK949E 300 mg / FK949E10012000004

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Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II)

The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. (NCT01725308)
Timeframe: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52

,
Interventionunits on a sale (Mean)
Week 1Week 2Week 3Week 4Week 6Week 8Week 10Week 12Week 14Week 16Week 18Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
FK949E 150 mg / FK949E-0.5-0.8-1.0-1.2-1.4-1.5-1.5-1.5-1.5-1.7-1.7-1.8-2.1-2.4-2.4-2.6-2.5-2.3-2.5-2.7-1.8
FK949E 300 mg / FK949E-0.4-0.7-1.0-1.2-1.3-1.5-1.6-1.7-1.7-1.7-2.0-1.9-2.0-2.0-2.1-2.0-2.1-2.2-2.3-2.4-1.6

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Change From Baseline in CGI-BP-S: Depression (Combined Treatment Period I and II)

The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from 1 (not ill) to 7 (very severely ill). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-12. (NCT01725308)
Timeframe: Baseline (Week 0 for FK949E 150 mg/FK949E & FK949E 300 mg/FK949E and Week 12 for Placebo/FK949E) and Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52

Interventionunits on a sale (Mean)
Week 14Week 16Week 18Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
Placebo / FK949E-0.3-0.5-0.7-0.7-0.8-0.8-0.8-0.9-0.9-0.9-0.9-0.9-0.8

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CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II)

The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 1)

,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4Week 6Week 8Week 10Week 12Week 14Week 16Week 18Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
FK949E 150 mg / FK949E3.53.12.92.72.62.52.52.62.62.42.52.32.11.92.11.91.82.01.91.72.5
FK949E 300 mg / FK949E3.53.22.92.72.72.52.42.42.42.42.22.32.22.22.22.12.11.92.01.82.7

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CGI-BP-C: Overall Bipolar Illness (Combined Treatment Period I and II)

The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 1)

Interventionunits on a scale (Mean)
Week 12Week 14Week 16Week 18Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
Placebo / FK949E2.72.42.32.12.01.91.92.01.91.81.81.91.82.1

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CGI-BP-C: Mania (Combined Treatment Period I and II)

The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 1)

,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4Week 6Week 8Week 10Week 12Week 14Week 16Week 18Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
FK949E 150 mg / FK949E4.04.04.04.04.04.04.04.04.04.04.04.04.04.04.04.04.04.04.04.03.9
FK949E 300 mg / FK949E4.04.04.04.04.04.04.04.04.04.04.04.04.04.04.04.04.04.04.04.04.1

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CGI-BP-C: Mania (Combined Treatment Period I and II)

The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 1)

Interventionunits on a scale (Mean)
Week 12Week 14Week 16Week 18Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
Placebo / FK949E4.03.93.93.93.94.03.94.04.04.04.04.03.94.0

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CGI-BP-C: Depression (Treatment Period I)

The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. (NCT01725308)
Timeframe: Weeks 1, 2, 3, 4, 6, 8

,,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4Week 6Week 8
FK949E 150 mg3.53.12.92.82.72.6
FK949E 300 mg3.53.23.02.92.82.8
Placebo3.73.63.43.23.23.1

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CGI-BP-C: Depression (Combined Treatment Period I and II)

The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 1)

,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4Week 6Week 8Week 10Week 12Week 14Week 16Week 18Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined period
FK949E 150 mg / FK949E3.53.12.92.72.62.52.52.62.62.42.52.32.11.92.01.81.82.01.91.72.5
FK949E 300 mg / FK949E3.53.12.92.72.72.52.42.42.42.42.22.22.22.22.12.12.11.91.91.82.6

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CGI-BP-C: Depression (Combined Treatment Period I and II)

The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 1)

Interventionunits on a scale (Mean)
Week 12Week 14Week 16Week 18Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined period
Placebo / FK949E2.72.42.32.12.01.91.91.91.91.81.81.91.82.0

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

InterventionParticipants (Count of Participants)
Week 12Week 16Week 32End of combined treatment period
Placebo / FK949E0112

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

InterventionParticipants (Count of Participants)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 36Week 40Week 48Week 52End of combined treatment period
FK949E 150 mg / FK949E000000000000

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Ideation - Suicidal Intent With a Plan (Combined Treatment Period I and II)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 5 items for suicide ideation (1. Wish to be dead; 2. Suicidal thoughts; 3. Suicidal thoughts with a method (no specific plan or intent to act); 4. Suicidal intent (without a specific plan); 5. Suicidal intent with specific plan. If participants responded with a negative response for questions 1 and 2, the remaining questions are skipped. If question 2 was responded to with a positive response, the remaining questions need to be asked. Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

InterventionParticipants (Count of Participants)
Week 4Week 8Week 12Week 16Week 24Week 28Week 36Week 40Week 44Week 48End of combined treatment period
FK949E 300 mg / FK949E00000000001

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors (Treatment Period I)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). (NCT01725308)
Timeframe: Weeks 4, 8

,,
Interventionparticipants (Number)
Week 4: Suicide attemptWeek 4: Self-injury w/o intentWeek 4: Discontinued attemptWeek 4: Interrupted attemptWeek 4: Preliminary act to suicideWeek 4: Suicidal behaviorWeek 4: Completed suicideWeek 8: Suicide attemptWeek 8: Self-injury w/o intentWeek 8: Discontinued attemptWeek 8: Interrupted attemptWeek 8: Preliminary act to suicideWeek 8: Suicidal behaviorWeek 8: Completed suicideEnd of Period I: Suicide attemptEnd of Period I: Self-injury w/o intentEnd of Period I: Discontinued attemptEnd of Period I: Interrupted attemptEnd of Period I: Preliminary act to suicideEnd of Period I: Suicidal behaviorEnd of Period I: Completed suicide
FK949E 150 mg000000000000000000000
FK949E 300 mg020000002000000200000
Placebo010000000000002100020

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

,
InterventionParticipants (Count of Participants)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
FK949E 150 mg / FK949E00000010000001
FK949E 300 mg / FK949E00000100000001

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicide Attempt (Combined Treatment Period I and II)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

InterventionParticipants (Count of Participants)
Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
Placebo / FK949E000000000001

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10 (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

,
InterventionParticipants (Count of Participants)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
FK949E 150 mg / FK949E00000010000101
FK949E 300 mg / FK949E00000100000001

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Suicidal Behavior (Combined Treatment Period I and II)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10 (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

InterventionParticipants (Count of Participants)
Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
Placebo / FK949E000000000002

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

,
InterventionParticipants (Count of Participants)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
FK949E 150 mg / FK949E00001000000000
FK949E 300 mg / FK949E22100000110101

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Self-injury Behavior Without Intent (Combined Treatment Period I and II)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

InterventionParticipants (Count of Participants)
Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
Placebo / FK949E010000000000

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Preliminary Act to Suicide (Combined Treatment Period I and II

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

,
InterventionParticipants (Count of Participants)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
FK949E 150 mg / FK949E00000000000000
FK949E 300 mg / FK949E00000000000000

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CGI-BP-C: Overall Bipolar Illness (Treatment Period I)

The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. (NCT01725308)
Timeframe: Weeks 1, 2, 3, 4, 6, 8

,,
Interventionunits on a scale (Mean)
Week 1Week 2Week 3Week 4Week 6Week 8
FK949E 150 mg3.53.12.92.82.72.6
FK949E 300 mg3.53.23.02.92.92.8
Placebo3.73.63.43.33.33.1

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

,
InterventionParticipants (Count of Participants)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
FK949E 150 mg / FK949E00000000000000
FK949E 300 mg / FK949E00000000000000

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Interrupted Attempt (Combined Treatment Period I and II)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

InterventionParticipants (Count of Participants)
Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
Placebo / FK949E000000000001

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

,
InterventionParticipants (Count of Participants)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52Endof combined treatment period
FK949E 150 mg / FK949E00000000000100
FK949E 300 mg / FK949E00000000000000

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Discontinued Attempt (Combined Treatment Period I and II)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

InterventionParticipants (Count of Participants)
Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52Endof combined treatment period
Placebo / FK949E000000000000

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

,
InterventionParticipants (Count of Participants)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
FK949E 150 mg / FK949E00000000000000
FK949E 300 mg / FK949E00000000000000

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Number of Participants With an Affirmative Response to C-SSRS: Suicidal Behaviors - Completed Suicide (Combined Treatment Period I and II)

The C-SSRS is a scale for assessing risk for suicidal behavior and suicide ideation and was administered by the clinician. Affirmative or negative responses were provided to 7 items to suicidal behaviors (1. suicide attempt; 2. Self-injury without suicide intent; 3. discontinued suicide attempt; 4. interrupted suicide attempt; 5. preliminary action to suicide; 6. suicidal behavior; 7. completed suicide). Baseline for Placebo / FK949E was at week 12 therefore no data were calculated for weeks 1-10. (NCT01725308)
Timeframe: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 (Placebo/FK949E only from week 12, FK949E 150 mg/FK949E & FK949E 300 mg/FK949E from week 4)

InterventionParticipants (Count of Participants)
Week 12Week 16Week 20Week 24Week 28Week 32Week 36Week 40Week 44Week 48Week 52End of combined treatment period
Placebo / FK949E000000000000

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Number of Participants With Adverse Events (Treatment Period I)

An adverse event (AE) is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. (NCT01725308)
Timeframe: Up to 8 weeks

,,
Interventionparticipants (Number)
Any AEDrug-related AEsDeathsSerious AEsDrug-related SAEsAEs that caused study drug discontimuationDrug-related AEs that caused study drug discont.
FK949E 150 mg555001065
FK949E 300 mg1491330002723
Placebo81521201611

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Number of Participants With Adverse Events (Combined Treatment Period I and II)

An AE is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. AEs reported are AEs that occurred after the start of the FK949E treatment for all groups. (NCT01725308)
Timeframe: Up to 54 weeks (Placebo / FK949E, from week 12 to week 52, for FK949E 150 mg / FK949E & FK949E 300 mg / FK949E groups, from week 0 to week 52)

,,
InterventionParticipants (Count of Participants)
Any AEDrug-related AEsDeathsSerious AEsDrug-related SAEsAEs that caused study drug discontimuationDrug-related AEs that caused study drug discont
FK949E 150 mg / FK949E63600421511
FK949E 300 mg / FK949E1711590525139
Placebo / FK949E1101000101513

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CGI-I Response Rate

CGI-I Response rate, where response was defined as a CGI-I score of 1 or 2 (very much improved or much improved), during double-blind randomized Phase B treatment. (NCT01727726)
Timeframe: Phase B week 6 (14/16 weeks after randomization).

InterventionParticipants (Count of Participants)
Brexpiprazole + ADT100
Seroquel XR + ADT48
Placebo + ADT79

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MADRS Response at Week 6

MADRS Response Rate, where response was defined as 50% reduction in MADRS Total Score, during double-blind randomized Phase B treatment. (NCT01727726)
Timeframe: Phase B week 6 (14/16 weeks after randomization).

InterventionParticipants (Count of Participants)
Brexpiprazole + ADT20
Seroquel XR + ADT8
Placebo + ADT14

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Montgomery Asberg Depression Rating Scale (MADRS)

To determine the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy by assessment of MADRS total score. The MADRS depression rating scale was used to assess the subject's level of depression by utilizing the structured interview guide for the MADRS (SIGMA). The MADRS consisted of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts), each rated 0 to 6. The overall score ranged from 0 (symptoms absent) to 60 (severe depression). Lower score indicated decreased severity of depression. (NCT01727726)
Timeframe: Randomization Visit (week 8 or week 10) to End of Double-Blind Treatment (week 14 or week 16).

InterventionUnits on a scale (Least Squares Mean)
Brexpiprazole + ADT-6.04
Seroquel XR + ADT-4.86
Placebo + ADT-4.57

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Number of Participants With MADRS

MADRS Remission Rate, where remission was defined as MADRS Total Score ≤ 10 and 50% reduction in MADRS Total Score, for every trial week visit during double-blind randomized Phase B treatment. (NCT01727726)
Timeframe: Phase B week 6 (14/16 weeks after randomization).

InterventionParticipants (Count of Participants)
Brexpiprazole + ADT13
Seroquel XR + ADT2
Placebo + ADT9

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Sheehan Disability Scale (SDS)

To evaluate mean change in SDS score from randomization (End of Phase A) to end of Phase B. The Sheehan Disability Scale is a measurement of functional disability and impairment due to psychiatric symptoms. The SDS is a visual analogue scale that uses spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the three domains ( work/social life/family life/home responsibilities). The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. Scores of 5 and above are associated with significant functional impairment. Additionally, SDS included 2 questions related to productivity losses due to the psychiatric symptoms and impairment. (NCT01727726)
Timeframe: Randomization Visit (week 8 or week 10) to End of Double-Blind Treatment (week 14 or week 16).

Interventionunits on a scale (Least Squares Mean)
Brexpiprazole + ADT-0.97
Seroquel XR + ADT-0.32
Placebo + ADT-0.74

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Change From End of Phase A in MADRS Total Score for Trial Week 2 and Week 4.

Change from end of Phase A in MADRS Total Score. The MADRS was used to assess the subject's level of depression by utilizing the structured interview guide for the MADRS (SIGMA). The MADRS depression rating scale was used to assess the subject's level of depression by utilizing the structured interview guide for the MADRS (SIGMA). The MADRS consisted of 10 items (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts and suicidal thoughts), each rated 0 to 6. The overall score ranged from 0 (symptoms absent) to 60 (severe depression). Lower score indicated decreased severity of depression. (NCT01727726)
Timeframe: Change from baseline to week 2 and week 4 in Phase B (week 10/12 and week 12/14)

,,
Interventionunits on a scale (Least Squares Mean)
Phase B Week 2Phase B Week 4
Brexpiprazole + ADT-2.57-4.39
Placebo + ADT-1.04-3.22
Seroquel XR + ADT-2.26-3.30

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Clinical Global Impression Score

Mean change from end of Phase A in Clinical Global Impression - Severity of Illness scale (CGI-S) score and Improvement scale (CGI-I) during double-blind randomized Phase B treatment. CGI-S score assessed how mentally ill the patient was at that time. CGI-S score is calculated from 0 to 7 (0 indicates not assessed 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and7 indicated among the most extremely ill patient). CGI-I score is compared to his/her condition at baseline, how much has the patient changed. CGI-I score is calculated from 0 to 7 (0 indicates not assessed and 7 indicates very much worse). (NCT01727726)
Timeframe: From randomization to Phase B week 6 (14/16 weeks after randomization).

,,
InterventionMean score (Mean)
CGI-Severity of Illness ScaleCGI-Improvement Scale Score
Brexpiprazole + ADT3.982.55
Placebo + ADT4.022.74
Seroquel XR + ADT4.072.71

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Number of Participants With Adverse Events

To evaluate the safety and tolerability of brexpiprazole (flexible dose) as adjunctive therapy to ADT in the proposed subject population with MDD as AE variables. (NCT01727726)
Timeframe: From screening (Day -28 to Day-1) upto post treatment follow-up.

,,
InterventionParticipants (Count of Participants)
DeathSerious TEAEDiscontinuation due to TEAEAny TEAE
Brexpiprazole + ADT002100
Placebo + ADT011107
Seroquel XR + ADT01458

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Sheehan Disability Scale (SDS) Individual Item Scores.

To evaluate mean change in SDS score from randomization (End of Phase A) to end of Phase B. The Sheehan Disability Scale (a self rated questionnaire) was used for measurement of functional disability and impairment due to psychiatric symptoms. The SDS is a visual analogue scale that uses spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the three domains (work/school work, social life/leisure activities and family life/home responsibilities). All domains were rated on a score scale ranged from 0 (no impairment) to 10 (most severe). Score of 5 and above indicated significant functional impairment. A total score was addition of the 3 individual scores and the total score ranged from 0 (no impairment) to 30 (most severe). (NCT01727726)
Timeframe: Randomization Visit (week 8 or week 10) to End of Double-Blind Treatment (week 14 or week 16).

,,
Interventionunits on a scale (Least Squares Mean)
Work/School ScoreSocial Life ScoreFamily Life Score
Brexpiprazole + ADT-0.59-1.03-1.02
Placebo + ADT-0.74-0.70-0.67
Seroquel XR + ADT-0.22-0.26-0.34

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Change From Baseline to Last Assessment in Treatment Period in Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness

The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill). (NCT01737268)
Timeframe: Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)

Interventionunits on a scale (Mean)
FK949E Elderly Participants-1.2

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Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Mania

The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill). (NCT01737268)
Timeframe: Baseline and and week 52 (or the time of last assessment for participants who discontinued earlier)

Interventionunits on a scale (Mean)
FK949E Elderly Participants0

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Change From Baseline to Last Assessment in Treatment Period in CGI-BP-S: Depression

The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill). (NCT01737268)
Timeframe: Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)

Interventionunits on a scale (Mean)
FK949E Elderly Participants-1.3

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CGI-BP-C: Mania

The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. (NCT01737268)
Timeframe: Week 52 (or the time of last assessment for participants who discontinued earlier)

Interventionunits on a scale (Mean)
FK949E Elderly Participants4.0

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CGI-BP-C: Depression

The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. (NCT01737268)
Timeframe: Week 52 (or the time of last assessment for participants who discontinued earlier)

Interventionunits on a scale (Mean)
FK949E Elderly Participant2.4

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Change From Baseline to Last Assessment in Treatment Period in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. (NCT01737268)
Timeframe: Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)

Interventionunits on a scale (Mean)
FK949E Elderly Participants-13.1

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Number of Participants With Adverse Events

An adverse event (AE) is defined as any undesirable or unintended sign (including abnormal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, re quire d or prolonged hospitalization or was considered medically important. (NCT01737268)
Timeframe: From first dose of study drug up to week 52 (52 weeks)

InterventionParticipants (Count of Participants)
Any AEDrug-related AEsDeathsSerious AEsDrug-related SAEsAEs that caused study drug discountinuationDrug-related AEs that caused study drug discont.
FK949E Elderly Participants181802187

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Clinical Global Impression-Bipolar-Change (CGI-BP-C): Overall Bipolar Illness

The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. (NCT01737268)
Timeframe: Week 52 (or the time of last assessment for participants who discontinued earlier)

Interventionunits on a scale (Mean)
FK949E Elderly Participants2.4

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Change From Baseline to Last Assessment in Treatment Period in Hamilton Depression Scale (HAM-D17)

The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52 with lower scores indicating less depressive symptoms. (NCT01737268)
Timeframe: Baseline and week 52 (or the time of last assessment for participants who discontinued earlier)

Interventionunits on a scale (Mean)
FK949E Elderly Participants-10.5

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Change From Baseline to Week 6 in PANSS Positive Subscale Score

The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Positive Subscale score is calculated from 7 items (for example: delusions, conceptual disorganization and hallucinatory behaviour). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms (NCT01810380)
Timeframe: Baseline and Week 6

Interventionunits on a scale (Mean)
Placebo-5.4
Brexpiprazole-7.0
Quetiapine Extended Release-8.1

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Change From Baseline to Week 6 in PANSS Negative Subscale Score

The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Negative Subscale score is calculated from 7 items (for example: blunted affect, emotional withdrawal and poor rapport). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms (NCT01810380)
Timeframe: Baseline and Week 6

Interventionunits on a scale (Mean)
Placebo-3.1
Brexpiprazole-3.7
Quetiapine Extended Release-4.5

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Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility/Excitement

The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: uncontrolled hostility/excitement is calculated from 4 items (for example: excitement, hostility, and uncooperativeness).Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms (NCT01810380)
Timeframe: Baseline and Week 6

Interventionunits on a scale (Mean)
Placebo-1.8
Brexpiprazole-2.5
Quetiapine Extended Release-2.8

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Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms

The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: positive symptoms is calculated from 8 items (for example: delusions, conceptual disorganization and stereotype thinking). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms (NCT01810380)
Timeframe: Baseline and Week 6

Interventionunits on a scale (Mean)
Placebo-5.7
Brexpiprazole-7.1
Quetiapine Extended Release-8.4

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Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms

The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: negative symptoms is calculated from 7 items (for example: blunted affect, emotional withdrawal and motor retardation). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms (NCT01810380)
Timeframe: Baseline and Week 6

Interventionunits on a scale (Mean)
Placebo-3.6
Brexpiprazole-4.3
Quetiapine Extended Release-4.8

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Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thoughts

The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: disorganized thoughts is calculated from 7 items (for example: conceptual disorganization, difficulty in abstract thinking and mannerisms and posturing). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms (NCT01810380)
Timeframe: Baseline and Week 6

Interventionunits on a scale (Mean)
Placebo-3.2
Brexpiprazole-4.0
Quetiapine Extended Release-4.8

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Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety/Depression

The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: anxiety/depression is calculated from 4 items (for example: anxiety, guilt feelings, and tension). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms (NCT01810380)
Timeframe: Baseline and Week 6

Interventionunits on a scale (Mean)
Placebo-2.9
Brexpiprazole-3.2
Quetiapine Extended Release-3.6

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Change From Baseline to Week 6 in PANSS General Psychopathology Subscale Score

The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS General Psychopathology Subscale score is calculated from 16 items (for example: somatic concern, anxiety and guilt feelings). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms (NCT01810380)
Timeframe: Baseline and Week 6

Interventionunits on a scale (Mean)
Placebo-8.2
Brexpiprazole-9.9
Quetiapine Extended Release-11.6

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Change From Baseline to Week 6 in CGI-S Score

"The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness.~The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients)." (NCT01810380)
Timeframe: Baseline and Week 6

Interventionunits on a scale (Mean)
Placebo-0.9
Brexpiprazole-1.2
Quetiapine Extended Release-1.4

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CGI-I Score at Week 6

"The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening).~The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not." (NCT01810380)
Timeframe: Week 6

Interventionunits on a scale (Mean)
Placebo3.0
Brexpiprazole2.7
Quetiapine Extended Release2.5

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Discontinuation Due to Lack of Efficacy During the Study

Discontinuation due to lack of efficacy was based on the primary reason for withdrawal (NCT01810380)
Timeframe: Baseline to Week 6

Interventionpercentage of patients (Number)
Placebo14.91
Brexpiprazole6.67
Quetiapine Extended Release7.19

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PSP Functional Remission Rate at Week 6

The PSP functional remission rate was defined as a PSP total score ≥71 (NCT01810380)
Timeframe: Week 6

Interventionpercentage of remitters (Number)
Placebo5.7
Brexpiprazole9.6
Quetiapine Extended Release14.4

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PSP Functional Response Rate at Week 6

The PSP functional response rate was defined as ≥10 point improvement from Baseline on the PSP total score (NCT01810380)
Timeframe: Week 6

Interventionpercentage of responders (Number)
Placebo36.3
Brexpiprazole53.4
Quetiapine Extended Release64.4

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Response Rate at Week 6

The response rate was defined as a reduction of ≥30% from baseline in PANSS total score OR a CGI-I score of 1 or 2 (NCT01810380)
Timeframe: Baseline and Week 6

Interventionpercentage of responders (Number)
Placebo32.1
Brexpiprazole48.7
Quetiapine Extended Release62.7

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Change From Baseline to Week 6 in PANSS Excited Component Score

The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Excited Component score is calculated from 5 items (for example: poor impulse control, tension and hostility). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms (NCT01810380)
Timeframe: Baseline and Week 6

Interventionunits on a scale (Mean)
Placebo-2.5
Brexpiprazole-3.3
Quetiapine Extended Release-3.9

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Change From Baseline to Week 6 in PANSS Total Score

The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranged from 30 to 210 with a higher score indicating greater severity of symptoms. (NCT01810380)
Timeframe: Baseline and Week 6

Interventionunits on a scale (Mean)
Placebo-15.9
Brexpiprazole-20.0
Quetiapine Extended Release-24.0

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PSP Domain D: Disturbing and Aggressive Behaviours at Week 6

"PSP domain D: disturbing and aggressive behaviours were categorised as aggressive (corresponding to mild, manifest, marked, severe, or very severe) or nonaggressive (corresponding to absent)" (NCT01810380)
Timeframe: Week 6

Interventionpercentage of aggressive patients (Number)
Placebo30.4
Brexpiprazole27.2
Quetiapine Extended Release22.2

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Change From Baseline to Week 6 in PSP Total Score

The Personal and Social Performance Scale (PSP) is a clinician-rated scale designed and validated to measure a patient's current level of social functioning. The PSP scale consists of a 100-point single-item rating scale, subdivided into 10 equal intervals. Scores of 1 to 10 indicate lack of autonomy in basic functioning, whereas scores of 91 to 100 reflect excellent functioning. The total score is rated by the investigator and is based on an algorithm which takes both the ratings of the 4 primary domains of PSP, and the combination of these ratings into account. The 4 primary domains are: socially useful activities (including work and study), personal and social relationships, self-care, and disturbing and aggressive behaviours. The 4 domains are assessed on a 6-point scale, from absent to very severe. A higher score indicates a better performance. (NCT01810380)
Timeframe: Baseline and Week 6

Interventionunits on a scale (Mean)
Placebo9.4
Brexpiprazole13.0
Quetiapine Extended Release15.3

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Loss of Motivated Behavior HAM-D Factor

includes the total of four HAM-D items: (Item 7: Work and activities, Item 12. Somatic symptoms (appetite), Item 14. Genital symptoms (libido), and Item 16. Weight loss). Range 0-11, higher scores indicate worse symptoms (NCT01833897)
Timeframe: 8 weeks

Interventionunits on a scale (final score) (Mean)
Ketamine and DCS Treatment1.6

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Beck's Depression Inventory

Range 0-63, with higher scores worse. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. (NCT01833897)
Timeframe: 8 weeks

Interventionunits on a scale (final score) (Mean)
Ketamine and DCS Treatment10.8

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HAM-D Suicide Item

Ham-D suicide item: range 0-4, higher scores indicate worse symptoms (NCT01833897)
Timeframe: 8 weeks

Interventionunits on a scale (final) (Mean)
Ketamine and DCS Treatment0.3

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Hamilton Anxiety Scale

Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indi- cates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. (NCT01833897)
Timeframe: 8 weeks

Interventionunits on a scale (final score) (Mean)
Ketamine and DCS Treatment6.4

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Hamilton Depression Rating Scale (HAM-D)

"Depression rating scale: Range 0-53, higher scores indicate worse depression. 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression~≥ 23 = Very Severe Depression" (NCT01833897)
Timeframe: 8 weeks

Interventionunits on a scale (final score) (Mean)
Ketamine and DCS Treatment9.5

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Weight Change

(NCT01844700)
Timeframe: baseline to week 12

,
Interventionlbs (Mean)
baselineweek 12 (n=1,2)
Aripiprazole, Quetiapine, Risperidone118.5141
Ziprasidone120.5151

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BMI Percentile

(NCT01844700)
Timeframe: baseline to week 12

,
InterventionBMI percentile (Mean)
baselineweek 12 (n=1, n=2)
Aripiprazole, Quetiapine, Risperidone37.6762.5
Ziprasidone3259

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BMI Z-scores

(NCT01844700)
Timeframe: baseline to week 12

,
InterventionBMI z-score (Mean)
baselineweek 12 (n=1, n=2)
Aripiprazole, Quetiapine, Risperidone-0.370.38
Ziprasidone-0.510.22

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Percent Weight Change Compared to Baseline Weight

(NCT01844700)
Timeframe: baseline to week 12

Interventionpercentage of weight change (Mean)
Ziprasidone11.58
Aripiprazole, Quetiapine, Risperidone5.66

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Body Mass Index (BMI)

"Body Mass Index (BMI) is a measure of body fat calculated as weight in kilograms divided by height in meters squared (kg/m^2). BMI Categories are:~Underweight = <18.5; Normal weight = 18.5-24.9; Overweight = 25-29.9; Obesity = BMI of 30 or greater. Greater decreases in BMI are a better outcome." (NCT01858948)
Timeframe: 24 weeks

Interventionkg/m^2 (Mean)
Quitiapine Plus Omega24.4
Quetiapine Plus Placebo26.3

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Fasting Blood Triglycerides Levels

Triglycerides are the chemical form in which most fat exists in food as well as in the body. They're also present in blood plasma and, in association with cholesterol, form the plasma lipids. Levels are categorized as follows: Normal - Less than 150 milligrams per deciliter (mg/dL); Borderline high - 150 to 199 mg/dL; High - 200 to 499 mg/dL; Very high - 500 mg/dL or above. Greater reductions blood triglyceride levels are a better outcome. (NCT01858948)
Timeframe: 24 weeks

Interventionmg/dL (Mean)
Quitiapine Plus Omega99.7
Quetiapine Plus Placebo88

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Manic Symptom Severity

Manic symptom ratings will be obtained using the Young Mania Rating Scale (YMRS). The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania: Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania). Greater reductions from baseline indicates a greater improvement in manic symptoms. (NCT01858948)
Timeframe: 24 weeks

Interventionunits on a scale (Mean)
Quitiapine Plus Omega4.3
Quetiapine Plus Placebo7.2

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Changes in Sexual Functioning Questionnaire (CSFQ)

Changes in Sexual Functioning Questionnaire (CSFQ) at week 16 as compared to baseline. The CSFQ assesses interest, functioning, and satisfaction in sex on a six-point scale, where 1 is greater than normal and 6 is totally absent, with full range from 5 (greater than normal) to 30 (totally absent). (NCT01971203)
Timeframe: baseline and week 16

,
Interventionunits on a scale (Mean)
BaselineLOCF
Placebo Plus CBT16.614.1
Seroquel XR Plus CBT15.11.8

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Clinical Global Impression Scales for Severity and Improvement

The Clinical Global Impression Scales for Severity and Improvement (CGI-I and CGI-S), both clinician rated, measures overall severity of symptoms and level of improvement on a seven-point scale from 0 (not applicable or not assessed) to 7, where 7 is the most severe. In order for a participant to be considered a treatment responder, he or she must receive a score of 1 (not ill or very much improved) or 2 (borderline mentally ill or much improved). (NCT01971203)
Timeframe: up to 16 weeks

,
Interventionunits on a scale (Mean)
CGI-S BaselineCGI-S LOCFCGI-I BaselineCGI-I LOCF
Placebo Plus CBT4.32.92.72.4
Seroquel XR Plus CBT4.12.53.31.8

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HAM-A

Hamilton Rating Scale for Anxiety (HAM-A) is a 14-item clinician-administered scale measuring symptoms with total scale from 0 (not present) to 56 (severe) to severe anxiety. (NCT01971203)
Timeframe: baseline and 16 weeks

,
Interventionunits on a scale (Mean)
BaselineLOCF (last observation carried forward)
Placebo Plus CBT17.89.4
Seroquel XR Plus CBT16.75.9

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MADRS

Montgomery-Åsberg Depression Rating Scale (MADRS) is a 10-item clinician-administered, with overall score ranges from 0 (normal) to 54 (severe depression). Score at 16 weeks as compared to baseline. (NCT01971203)
Timeframe: baseline and 16 weeks

,
Interventionunits on a scale (Mean)
BaselineLOCF (last observation carried forward)
Placebo Plus CBT28.615.7
Seroquel XR Plus CBT27.19.1

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Change in Delirium Severity

Participants were screened for delirium daily using the Cornell Assessment for Pediatric Delirium, which assigns a delirium score between 0 (no delirium) to 32 (severe delirium). This describes the change in delirium score between study drug initiation (either quetiapine or placebo) and 72 hours. A decrease in score implies an improvement in delirium severity. For the quetiapine group, there was a median decrease in scale score (for the 3 subjects) of 1; for the placebo group, there was no change in delirium screen scores. (NCT02056171)
Timeframe: Baseline and 3 days of study drug initiation

Interventionunits on a scale (Median)
Quetiapine1
Placebo0

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Time to First Resolution of Delirium

Participants were screened for delirium daily. This describes the number of days from study drug initiation (either quetiapine or placebo) to first resolution of delirium (defined as a score of less than 9 on teh Cornell Assessment of Pediatric Delirium [CAPD]). If delirium did not resolve within the 10 day period, this defaults to 10 days. (NCT02056171)
Timeframe: Within the first 10 days after study enrollment

Interventiondays (Mean)
Quetiapine8
Placebo7

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Total ICU Days With Delirium

Participants were screened for delirium daily. This describes the number of days with delirium within the 10 day study period. (NCT02056171)
Timeframe: Within 10 days after study enrollment

Interventiondays (Mean)
Quetiapine8
Placebo7

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Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

The MADRS is a 10-item scale to measure the severity of depressive episodes, where each item is rated on a scale from 0 to 6. The MADRS total score ranges from 0 to 60 with lower scores indicating less depressive symptoms. (NCT02362412)
Timeframe: Week 8 of each treatment period (Week 12 and Week 20)

InterventionUNITS ON A SCALE (Least Squares Mean)
FK949E 50 mg Tablets7.4
FK949E 150 mg Tablets7.9

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Clinical Global Impression-Bipolar-Change (CGI-BP-C):Mania

The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. (NCT02362412)
Timeframe: Week 8 of each treatment period (Week 12 and Week 20)

InterventionUnits on a scale (Mean)
FK949E 50 mg Tablets4.0
FK949E 150 mg Tablets4.0

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Clinical Global Impression-Bipolar-Change (CGI-BP-C):Depression

The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. (NCT02362412)
Timeframe: Week 8 of each treatment period (Week 12 and Week 20)

InterventionUnits on a scale (Least Squares Mean)
FK949E 50 mg Tablets2.0
FK949E 150 mg Tablets2.0

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Number of Participants With Adverse Events

An adverse event (AE) is defined as any undesirable or unintended sign (including abnonmal laboratory test values), symptom, or disease occurring while the study drug was administered, regardless of whether or not there was a causal relationship with the study drug. A serious AE is defined as a an event resulting in death, persistent or significant disability/incapacity or congenital anomaly or birth defect, was life-threatening, required or prolonged hospitalization or was considered medically important. (NCT02362412)
Timeframe: Up to 22 weeks

,,,
InterventionParticipants (Number)
Any AEDrug-related AEsDeathsSerious AEsDrug-related SAEsAEs that caused study drug discontinuationDrug-related AEs that caused study drug discont.
Treatment Period II FK949E 150 mg2100000
Treatment Period II FK949E 50 mg1000000
Treatment Period III FK949E 150 mg5200000
Treatment Period III FK949E 50 mg2000000

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Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Mania

The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill) (NCT02362412)
Timeframe: Week 8 of each treatment period (Week 12 and Week 20)

InterventionUnits on a scale (Mean)
FK949E 50 mg Tablets1.0
FK949E 150 mg Tablets1.0

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Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S):Depression

The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill). (NCT02362412)
Timeframe: Week 8 of each treatment period (Week 12 and Week 20)

InterventionUnits on a scale (Least Squares Mean)
FK949E 50 mg Tablets2.1
FK949E 150 mg Tablets2.0

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Hamilton Depression Scale (HAM-D17)

The HAM-D17 is a clinician-rated 17-item scale for assessing the severity of depression symptoms. The scores for each item range from 0 to 4 or 0 to 2, where 0 represents no symptoms. The rating is based on the past 7 days prior to the time of assessment. The total score ranges from 0 to 52 with lower scores indicating less depressive symptoms. (NCT02362412)
Timeframe: Week 8 of each treatment period (Week 12 and Week 20)

InterventionUnits on a scale (Least Squares Mean)
FK949E 50 mg Tablets5.5
FK949E 150 mg Tablets5.4

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Clinical Global Impression-Bipolar-Change (CGI-BP-C):Overall Bipolar Illness

The CGI-BP-C is a scale which assesses the degree of change or improvement from baseline for each of overall bipolar illness, depression and mania, by grading it using 8 grades, from 1 (very much improved) to 7 (very much worse) or 8 (not applicable). Grade 8 (not applicable) was regarded as a missing value for purposes of calculating the mean score. (NCT02362412)
Timeframe: Week 8 of each treatment period (Week 12 and Week 20)

InterventionUnits on a scale (Least Squares Mean)
FK949E 50 mg Tablets2.0
FK949E 150 mg Tablets2.0

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Clinical Global Impression-Bipolar-Severity of Illness (CGI-BP-S): Overall Bipolar Illness

The CGI-BP-S is a scale which assesses a participant's severity of their overall bipolar illness, depression, and mania as assessed by the clinician using a scale from with the scale from 1 (Normal, not ill) to 7 (very severely ill). (NCT02362412)
Timeframe: Week 8 of each treatment period (Week 12 and Week 20)

InterventionUnits on a scale (Least Squares Mean)
FK949E 50 mg Tablets2.1
FK949E 150 mg Tablets2.0

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Part 3 (EDP): Change From Baseline in Reasoning and Problem Solving: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess reasoning and problem solving score of participants. The range of reasoning and problem solving T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and 18 Months

InterventionT-score (Mean)
Part 3-PP to PP3.4
Part 3-OAP to OAP4.7

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Part 3 (EDP): Change From Baseline in Medication Satisfaction Questionnaire (MSQ) Score

The Medication Satisfaction Questionnaire (MSQ) is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied). Total score ranges from 1 to 7. Higher score indicate improvement. (NCT02431702)
Timeframe: Baseline, up to 18 Months

Interventionunits on a scale (Mean)
Part 3-PP to PP0.3
Part 3-OAP to OAP0.4

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Part 3 (EDP): Change From Baseline in Functioning as Measured by the Personal and Social Performance (PSP) Total Score

The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: 1) socially useful activities, 2) personal and social relationships, 3) self-care, and 4) disturbing and aggressive behavior. Each domain was assessed on a 6-point scale, from 1 (absent) to 6 (very severe) (1 = absent, 2 = mild, 3 = manifest, 4 = marked, 5 = severe, and 6 = very severe). PSP total score was calculated as sum of all the domain scores and ranges from 1 to 100. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. Higher score indicate better performance. (NCT02431702)
Timeframe: Baseline and 18 Months

Interventionunits on a scale (Mean)
Part 3-PP to PP7.5
Part 3-OAP to OAP7.0

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Part 3 (EDP): Change From Baseline in Clinical Global Impression Severity (CGI-S) Score

"The Clinical Global Impression Severity (CGI-S) rating scale is used to rate the severity of a participant's overall clinical condition on a 7 point scale. The total score ranges from 1 to 7, where 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening." (NCT02431702)
Timeframe: Baseline, up to 18 Months

Interventionunits on a scale (Mean)
Part 3-PP to PP-0.7
Part 3-OAP to OAP-0.7

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Part 3 (EDP): Change From Baseline in Attention/Vigilance Score: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess attention/vigilance score of participants. The range of attention/vigilance score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and 18 Months

InterventionT-score (Mean)
Part 3-PP to PP2.4
Part 3-OAP to OAP0.7

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Part 3 (EDP): Change From Baseline in Adjusted Intracortical Myelin Fraction Score as Measured by Inversion Recovery (IR) and Spin Echo Magnetic Resonance Imaging (MRI)

"The adjusted ICM fraction score is quantified as: 1. The volume of myelinated brain tissue is measured separately on co-localized IR and proton density (PD) MRI images, by outlining the boundary between gray matter and white matter on each image. 2. ICM is calculated from the difference of IR volume minus PD volume. 3. ICM is then expressed as a fraction of the total intracranial volume (ICM divided by intracranial volume). 4. The ICM fraction is then adjusted for effects of age, gender, and race/ethnicity in the sample of treated participants and healthy controls. A decrease in the adjusted ICM fraction score may be a sign of disease progression." (NCT02431702)
Timeframe: Baseline and 18 Months

Interventionratio (Mean)
Part 3-PP to PP-0.001
Part 3-OAP to OAP-0.003

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Part 3 (Disease Modification): Personal and Social Performance (PSP) Total Observed Score

The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: 1) socially useful activities, 2) personal and social relationships, 3) self-care, and 4) disturbing and aggressive behavior. Score ranges from 1 to 100, divided into 10 equal intervals to rate degree of difficulty (1 = absent, 2 = mild, 3 = manifest, 4 = marked, 5 = severe, and 6 = very severe) in each of the 4 domains. Based on 4 domains there will be 1 transformed total score. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. (NCT02431702)
Timeframe: Month 9 of Part 3

Interventionunits on a scale (Least Squares Mean)
Part 3-PP to PP67.6
Part 3- OAP to PP (or Delayed-Start PP)66.1
Part 3-OAP to OAP66.6

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Part 3 (Disease Modification): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score and composites scores. The range of T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and Day 260

InterventionT-score (Mean)
Part 3- PP to PP-0.7
Part 3- OAP to PP (or Delayed-Start PP)-0.2
Part 3-OAP to OAP0.5

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Part 2 (Disease Progression): Change From Baseline in Working Memory Score: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess working memory of participants. The range of working memory score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and Day 260

InterventionT-score (Mean)
Part-2: Paliperidone Palmitate (PP)-0.2
Part-2: OAP-0.8

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Part 2 (Disease Progression): Change From Baseline in Visual Learning Score: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess visual learning score of participants. The range of visual learning score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and Day 260

InterventionT-score (Mean)
Part-2: Paliperidone Palmitate (PP)1.3
Part-2: OAP1.4

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Part 2 (Disease Progression): Change From Baseline in Speed of Processing Score: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess speed of processing score of participants. The range of speed of processing T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and Day 260

InterventionT-score (Mean)
Part-2: Paliperidone Palmitate (PP)1.8
Part-2: OAP3.5

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Part 2 (Disease Progression): Change From Baseline in Social Cognition Score: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess social cognition score of participants. The range of social cognition score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and Day 260

InterventionT-score (Mean)
Part-2: Paliperidone Palmitate (PP)0.3
Part-2: OAP1.6

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Part 2 (Disease Progression): Change From Baseline in Reasoning and Problem Solving: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess reasoning and problem solving of participants. The range of reasoning and problem solving T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and Day 260

InterventionT-score (Mean)
Part-2: Paliperidone Palmitate (PP)0.2
Part-2: OAP2.8

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Part 2 (Disease Progression): Change From Baseline in Medication Satisfaction Questionnaire (MSQ) Total Score

The Medication Satisfaction Questionnaire (MSQ) is a 7-point, verbally administered, Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7=Extremely Satisfied. Worst value is 1 (Extremely Dissatisfied) and best value is 7 (Extremely Satisfied). Total score ranges from 1 to 7. Higher score indicate improvement. (NCT02431702)
Timeframe: Baseline and endpoint Part 2 (up to 9 Months)

Interventionunits on a scale (Mean)
Part-2: Paliperidone Palmitate (PP)-0.2
Part-2: OAP0.1

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Part 2 (Disease Progression): Change From Baseline in Functioning as Measured by the Personal and Social Performance (PSP) Total Score

The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: 1) socially useful activities, 2) personal and social relationships, 3) self-care, and 4) disturbing and aggressive behavior. Each domain was assessed on a 6-point scale, from 1 (absent) to 6 (very severe) (1 = absent, 2 = mild, 3 = manifest, 4 = marked, 5 = severe, and 6 = very severe). PSP total score was calculated as sum of all the domain scores and ranges from 1 to 100. Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision. Higher score indicate better performance. (NCT02431702)
Timeframe: Baseline and Month 9

Interventionunits on a scale (Mean)
Part-2: Paliperidone Palmitate (PP)2.5
Part-2: OAP2.9

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Part 2 (Disease Progression): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score and composites scores. The range of T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and Month 9

InterventionT-score (Least Squares Mean)
Part-2: Paliperidone Palmitate (PP)2.0
Part-2: OAP2.8

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Part 2 (Disease Progression): Change From Baseline in Clinical Global Impression Severity (CGI-S) Score

"The Clinical Global Impression Severity (CGI-S) rating scale is used to rate the severity of a participant's overall clinical condition on a 7 point scale. The score ranges from 1 to 7, where 1 is equivalent to Normal, not at all ill and a rating of 7 is equivalent to Among the most extremely ill participants. Higher scores indicate worsening." (NCT02431702)
Timeframe: Baseline, up to 9 Months of Part 2

Interventionunits on a scale (Mean)
Part-2: Paliperidone Palmitate (PP)-0.2
Part-2: OAP-0.3

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Part 2 (Disease Progression): Change From Baseline in Attention/Vigilance Score: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess attention/vigilance score of participants. The range of attention/vigilance score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and Day 260

InterventionT-score (Mean)
Part-2: Paliperidone Palmitate (PP)3.2
Part-2: OAP0.7

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Part 2 (Disease Progression): Change From Baseline in Adjusted Intracortical Myelin (ICM) Fraction Score as Measured by Inversion Recovery (IR) and Spin Echo Magnetic Resonance Imaging (MRI)

"The adjusted ICM fraction score is quantified as: 1. The volume of myelinated brain tissue is measured separately on co-localized IR and proton density (PD) MRI images, by outlining the boundary between gray matter and white matter on each image. 2. ICM is calculated from the difference of IR volume minus PD volume. 3. ICM is then expressed as a fraction of the total intracranial volume (ICM divided by intracranial volume). 4. The ICM fraction is then adjusted for effects of age, gender, and race/ethnicity in the sample of treated participants and healthy controls. A decrease in the adjusted ICM fraction score may be a sign of disease progression." (NCT02431702)
Timeframe: Baseline and Day 260

Interventionratio (Mean)
Part-2: Paliperidone Palmitate (PP)-0.001
Part-2: OAP-0.004

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Part 3 (EDP): Time to First Treatment Failure

Treatment failure is defined as the time from participant's randomization to first treatment failure, which was a composite endpoint consisting of any of the following: 1) Psychiatric hospitalization due to worsening symptoms; 2) Any deliberate self-injury, suicidal ideation or behavior, homicidal ideation or violent behavior that is clinically significant and needs immediate intervention as determined by the study physician; 3) New arrest/incarceration; 4) Discontinuation of antipsychotic treatment due to inadequate efficacy as determined by the study physician; 5) Discontinuation of antipsychotic treatment due to safety or tolerability as determined by the study physician; 6) Treatment supplementation with another antipsychotic due to inadequate efficacy as determined by the study physician; 7) Increase in the level of psychiatric services in order to prevent imminent psychiatric hospitalization as determined by the study physician. (NCT02431702)
Timeframe: From Day 1 Up to 18 Months

Interventiondays (Median)
Part 3-PP to PPNA
Part 3-OAP to OAPNA

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Part 3 (EDP): Number of Participants With Change From Baseline in Severity of Psychotic Symptoms, as Measured by CRDPSS

The CRDPSS is an 8-item measure that assesses the severity of mental health symptoms that are important across psychotic disorders, including delusions, hallucinations, disorganized speech, abnormal psychomotor behavior, negative symptoms. Each item on the measure is rated on a 5-point scale (0=none; 1=equivocal; 2=present, but mild; 3=present and moderate; and 4=present and severe). Total Score is taken as summation. A higher score indicates a more severe condition. Worsened or improved is defined as increase or decrease compared to baseline. (NCT02431702)
Timeframe: Baseline, up to 18 Months

InterventionParticipants (Count of Participants)
Hallucinations72513609Hallucinations72513610Delusions72513609Delusions72513610Disorganized Speech72513609Disorganized Speech72513610Abnormal Psychomotor Behavior72513609Abnormal Psychomotor Behavior72513610Negative Symptoms72513609Negative Symptoms72513610Impaired Cognition72513609Impaired Cognition72513610Mania72513609Mania72513610Depression72513609Depression72513610
WorsenedUnchangedImproved
Part 3-PP to PP3
Part 3-OAP to OAP8
Part 3-PP to PP27
Part 3-OAP to OAP29
Part 3-PP to PP11
Part 3-OAP to OAP10
Part 3-PP to PP6
Part 3-PP to PP21
Part 3-OAP to OAP20
Part 3-PP to PP14
Part 3-OAP to OAP17
Part 3-PP to PP2
Part 3-OAP to OAP36
Part 3-PP to PP12
Part 3-PP to PP4
Part 3-OAP to OAP2
Part 3-PP to PP32
Part 3-OAP to OAP37
Part 3-PP to PP5
Part 3-OAP to OAP4
Part 3-OAP to OAP22
Part 3-PP to PP19
Part 3-OAP to OAP21
Part 3-PP to PP10
Part 3-OAP to OAP9
Part 3-OAP to OAP23
Part 3-PP to PP17
Part 3-OAP to OAP15
Part 3-PP to PP0
Part 3-OAP to OAP3
Part 3-PP to PP40
Part 3-OAP to OAP39
Part 3-PP to PP1
Part 3-OAP to OAP5
Part 3-PP to PP7
Part 3-OAP to OAP6
Part 3-PP to PP26
Part 3-PP to PP8
Part 3-OAP to OAP12

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Part 2 (Disease Progression): Number of Participants With Change From Baseline in Severity of Psychotic Symptoms, as Measured by Clinician-Rated Dimensions of Psychosis Symptom Severity Scale (CRDPSS)

The CRDPSS is an 8-item measure that assesses the severity of mental health symptoms that are important across psychotic disorders, including delusions, hallucinations, disorganized speech, abnormal psychomotor behavior, negative symptoms. Each item on the measure is rated on a 5-point scale (0=none; 1=equivocal; 2=present, but mild; 3=present and moderate; and 4=present and severe). Total Score is taken as summation. A higher score indicates a more severe condition. Worsened or improved is defined as increase or decrease compared to baseline. (NCT02431702)
Timeframe: Baseline, up to 9 Months

InterventionParticipants (Count of Participants)
Hallucinations72513608Hallucinations72513614Delusions72513614Delusions72513608Disorganized Speech72513614Disorganized Speech72513608Abnormal Psychomotor Behavior72513614Abnormal Psychomotor Behavior72513608Negative Symptoms72513608Negative Symptoms72513614Impaired Cognition72513614Impaired Cognition72513608Mania72513608Mania72513614Depression72513608Depression72513614
UnchangedImprovedWorsened
Part-2: OAP19
Part-2: Paliperidone Palmitate (PP)29
Part-2: OAP73
Part-2: Paliperidone Palmitate (PP)14
Part-2: OAP33
Part-2: Paliperidone Palmitate (PP)10
Part-2: OAP20
Part-2: Paliperidone Palmitate (PP)23
Part-2: OAP70
Part-2: OAP35
Part-2: OAP13
Part-2: Paliperidone Palmitate (PP)36
Part-2: OAP85
Part-2: Paliperidone Palmitate (PP)12
Part-2: OAP27
Part-2: Paliperidone Palmitate (PP)9
Part-2: OAP14
Part-2: Paliperidone Palmitate (PP)37
Part-2: OAP86
Part-2: Paliperidone Palmitate (PP)4
Part-2: OAP25
Part-2: Paliperidone Palmitate (PP)16
Part-2: OAP61
Part-2: Paliperidone Palmitate (PP)17
Part-2: OAP39
Part-2: Paliperidone Palmitate (PP)13
Part-2: OAP29
Part-2: Paliperidone Palmitate (PP)22
Part-2: OAP52
Part-2: Paliperidone Palmitate (PP)15
Part-2: OAP44
Part-2: Paliperidone Palmitate (PP)1
Part-2: OAP7
Part-2: Paliperidone Palmitate (PP)47
Part-2: OAP107
Part-2: Paliperidone Palmitate (PP)2
Part-2: OAP11
Part-2: Paliperidone Palmitate (PP)7
Part-2: OAP28
Part-2: Paliperidone Palmitate (PP)33
Part-2: OAP74
Part-2: OAP23

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Part-2 (Disease Progression): Time to First Treatment Failure

Treatment failure is defined as the time from participant's randomization to first treatment failure, which was a composite endpoint consisting of any of the following: 1) Psychiatric hospitalization due to worsening symptoms; 2) Any deliberate self-injury, suicidal ideation or behavior, homicidal ideation or violent behavior that is clinically significant and needs immediate intervention as determined by the study physician; 3) New arrest/incarceration; 4) Discontinuation of antipsychotic treatment due to inadequate efficacy as determined by the study physician; 5) Discontinuation of antipsychotic treatment due to safety or tolerability as determined by the study physician; 6) Treatment supplementation with another antipsychotic due to inadequate efficacy as determined by the study physician; 7) Increase in the level of psychiatric services in order to prevent imminent psychiatric hospitalization as determined by the study physician. (NCT02431702)
Timeframe: From Day 1 up to 9 Months

Interventiondays (Median)
Part-2: Paliperidone Palmitate (PP)NA
Part-2: OAPNA

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Part 3 (Extended Disease Progression [EDP]): Change From Baseline in Cognition as Measured by the MATRICS Consensus Cognitive Battery (MCCB) Composite Score

The MATRICS Consensus Cognitive Battery is an instrument that contains 10 tests to measure cognitive performance in 7 cognitive domains: speed processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The composite score combines the individual scores of the 10 tests and scores them on a normative scale to derive a T-score and composites scores. The range of T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and 18 Months

InterventionT-score (Mean)
Part 3-PP to PP1.6
Part 3-OAP to OAP3.2

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Part 2 (Disease Progression): Change From Baseline in Verbal Learning Score: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess verbal learning score of participants. The range of verbal learning score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and Day 260

InterventionT-score (Mean)
Part-2: Paliperidone Palmitate (PP)1.3
Part-2: OAP1.0

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Part 3 (EDP): Change From Baseline in Working Memory Score: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess working memory of participants. The range of working memory score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and 18 Months

InterventionT-score (Mean)
Part 3-PP to PP-1.7
Part 3-OAP to OAP0.7

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Part 3 (EDP): Change From Baseline in Visual Learning Score: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess visual learning score of participants. The range of visual learning score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and 18 Months

InterventionT-score (Mean)
Part 3-PP to PP0.2
Part 3-OAP to OAP-0.2

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Part 3 (EDP): Change From Baseline in Verbal Learning Score: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess verbal learning score of participants. The range of verbal learning score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and 18 Months

InterventionT-score (Mean)
Part 3-PP to PP0.3
Part 3-OAP to OAP0.8

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Part 3 (EDP): Change From Baseline in Speed of Processing Score: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess speed of processing score of participants. The range of speed of processing score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and 18 Months

InterventionT-score (Mean)
Part 3-PP to PP2.5
Part 3-OAP to OAP4.9

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Part 3 (EDP): Change From Baseline in Social Cognition Score: MCCB Domain

MCCB measures cognitive function across cognitive domains and is comprised of 10 independent tests assessing 7 cognitive domains (speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition). A subset of the MCCB cognitive domain was used to assess social cognition score of participants. The range of social cognition score T-scores for a normal control population is between 0 to 100 with a mean of 50 and standard deviation of 10. Higher scores indicate better cognitive functioning. (NCT02431702)
Timeframe: Baseline and 18 Months

InterventionT-score (Mean)
Part 3-PP to PP-0.2
Part 3-OAP to OAP1.4

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Part 3 (Disease Modification): Change From Baseline in Adjusted Intracortical Myelin Fraction Score as Measured by Inversion Recovery (IR) and Spin Echo Magnetic Resonance Imaging (SE MRI)

"The adjusted ICM fraction score is quantified as: 1. The volume of myelinated brain tissue is measured separately on co-localized IR and proton density (PD) MRI images, by outlining the boundary between gray matter and white matter on each image. 2. ICM is calculated from the difference of IR volume minus PD volume. 3. ICM is then expressed as a fraction of the total intracranial volume (ICM divided by intracranial volume). 4. The ICM fraction is then adjusted for effects of age, gender, and race/ethnicity in the sample of treated participants and healthy controls. A decrease in the adjusted ICM fraction score may be a sign of disease progression." (NCT02431702)
Timeframe: Baseline and Month 9 of Part 3

Interventionratio (Least Squares Mean)
Part 3-PP to PP-0.7
Part 3- OAP to PP (or Delayed-Start PP)-0.2
Part 3-OAP to OAP0.5

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Adherence to Antipsychotic Medication as Assessed by Brief Adherence Rating Scale (BARS) at Week 0 and 12

The BARS is a 4-item scale that includes 3 questions and an overall visual analog rating scale that assesses participant's knowledge about his/her medication. The key measure of adherence is the visual analog scale and assesses the percentage of doses taken by the participants in the past month (0 percent [%] - 100%). The 3 questions include: number of prescribed doses per day, number of days in the past month when the participant did not take the prescribed doses, and the number of days in the past month when the participant took less than the prescribed dose. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported. (NCT02462473)
Timeframe: Week 0, Week 12

Interventionpercent adherence (Number)
Participant 1 (Week 0)Participant 1 (Week 12)Participant 2 (Week 0)Participant 2 (Week 12)Participant 3 (Week 0)Participant 3 (Week 12)Participant 4 (Week 0)Participant 5 (Week 0)Participant 5 (Week 12)Participant 6 (Week 0)Participant 6 (Week 12)Participant 7 (Week 0)Participant 7 (Week 12)Participant 8 (Week 0)Participant 8 (Week 12)Participant 9 (Week 0)Participant 9 (Week 12)
Cohort 110010010010010010097939090969095100100100100

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Number of Participants With Medication Treatment Modifications (MTM)

Information on MTMs derived from data collected in the clinical assessment of the schizophrenia patient (CASP) questionnaire. The CASP captured changes in medications, changes in psychosocial treatments, visit frequency, and the need for any acute interventions. The CASP comprised of 3 sections covering several parameters. The CASP captured changes in treatment options which was used to compute MTM, as well as factors in clinical decision making and the influence of antipsychotic medication plasma levels (AMPL), when they were available, on clinical decision making. (NCT02462473)
Timeframe: Up to Week 12

InterventionParticipants (Number)
Cohort 14

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Clinician's Rating Scale of Adherence (CRS) Score at Week 0 and 12

The CRS is an ordinal scale filled by the clinician. The scores range from 1 to 7 that were used to quantify the clinician's assessment of treatment adherence by the patient. Higher scores indicate greater adherence. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported. (NCT02462473)
Timeframe: Week 0, Week 12

Interventionunits on a scale (Number)
Participant 1 (Week 0)Participant 1 (Week 12)Participant 2 (Week 0)Participant 2 (Week 12)Participant 3 (Week 0)Participant 3 (Week 12)Participant 4 (Week 0)Participant 5 (Week 0)Participant 5 (Week 12)Participant 6 (Week 0)Participant 6 (Week 12)Participant 7 (Week 0)Participant 7 (Week 12)Participant 8 (Week 0)Participant 8 (Week 12)Participant 9 (Week 0)Participant 9 (Week 12)
Cohort 177777777777777777

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Dimensions of Psychosis Symptom Severity Scale (DPSS) Total Score at Week 0 and 12

The DPSS is a clinician-rated scale used to rate 8 domains commonly seen in patients with psychotic disorders. Each domain was rated on a 5-point scale (0 to 4) with anchored description of endpoints. Total score was computed by summing the scores of individual items (range of 0-32). Higher scores represent more severe condition. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported. (NCT02462473)
Timeframe: Week 0, Week 12

Interventionunits on a scale (Number)
Participant 1 (Week 0)Participant 1 (Week 12)Participant 2 (Week 0)Participant 2 (Week 12)Participant 3 (Week 0)Participant 3 (Week 12)Participant 4 (Week 0)Participant 5 (Week 0)Participant 5 (Week 12)Participant 6 (Week 0)Participant 6 (Week 12)Participant 7 (Week 0)Participant 7 (Week 12)Participant 8 (Week 0)Participant 8 (Week 12)Participant 9 (Week 0)Participant 9 (Week 12)
Cohort 11248288149474584446

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Number of Participants With Factors Considered in Clinical Decision as Assessed by Clinical Assessment of the Schizophrenia Patient (CASP)

The CASP and data on concomitant medications and psychosocial treatments were used to evaluate the impact of AMPL results on other aspects of clinical decision making. (NCT02462473)
Timeframe: Up to Week 12

Interventionparticipants (Number)
Side Effects Of MedicationAttitude Toward TreatmentReport of Increased SymptomsReport of Decrease in SymptomsPatient Still SymptomaticPatient Ideation
Cohort 1324311

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Patient Satisfaction Survey (PSS) Total Score at Week 0 and 12

The PSS is a brief scale designed to capture a psychiatric patient's satisfaction with a clinician. The scale covers 6 domains: Trust (3 items), Communication (3 items), Exploration of Ideas/Options (2 items), Body Language (2 items), Active Listening (4 items), and Miscellaneous Items (6 items). Out of the 20 items, the first 19 are scored on a 5-point Likert Scale (1=strongly disagree, 2=disagree, 3=satisfactory, 4=agree, 5=strongly agree). The last question (6f) is a free-response question asking for input on how the clinician might improve. Sum of scores of individual items give a total score (range 9-95). Higher scores indicate greater degree of satisfaction. Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported. (NCT02462473)
Timeframe: Week 0, Week 12

Interventionunits on a scale (Number)
Participant 1 (Week 0)Participant 1 (Week 12)Participant 2 (Week 0)Participant 2 (Week 12)Participant 3 (Week 0)Participant 3 (Week 12)Participant 4 (Week 0)Participant 5 (Week 0)Participant 5 (Week 12)Participant 6 (Week 0)Participant 6 (Week 12)Participant 7 (Week 0)Participant 7 (Week 12)Participant 8 (Week 0)Participant 8 (Week 12)Participant 9 (Week 0)Participant 9 (Week 12)
Cohort 17676525757574866647676767263727176

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Antipsychotic Medication Plasma Levels (AMPL) During the Active Assessment Phase at Week 12

AMPL of the individual participant during the active assessment phase was reported. (NCT02462473)
Timeframe: Week 12

Interventionnanogram per milliliter (Number)
Participant 1- ARIPIPRAZOLEParticipant 1- DEHYDROARIPIPRAZOLEParticipant 2- OLANZAPINEParticipant 2- PALIPERIDONEParticipant 3- 7-OH QUETIAPINEParticipant 3-NORQUETIAPINEParticipant 3-QUETIAPINEParticipant 3-QUETIAPINE SULFOXIDEParticipant 5-7-OH QUETIAPINEParticipant 5-NORQUETIAPINEParticipant 5-QUETIAPINEParticipant 5-QUETIAPINE SULFOXIDEParticipant 6-ARIPIPRAZOLEParticipant 6-DEHYDROARIPIPRAZOLEParticipant 7-PALIPERIDONEParticipant 7-RISPERIDONEParticipant 8-ARIPIPRAZOLEParticipant 8-DEHYDROARIPIPRAZOLEParticipant 9- 7-OH QUETIAPINEParticipant 9- NORQUETIAPINEParticipant 9- PALIPERIDONEParticipant 9- QUETIAPINEParticipant 9- QUETIAPINE SULFOXIDEParticipant 9- RISPERIDONE
Cohort 1596.00139.0027.3045.1043.10660.00280.00660.007.72153.0050.30321.00464.00112.0031.0026.20168.0033.000.2002.000.1002.002.000.100

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Clinical Global Impression-Severity (CGI-S) Score at Week 0 and 12

Clinical Global Impression-Severity (CGI-S) rating scale used to rate the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). Due to early study termination collected data was not summarized. Hence, individual data for each participant was reported. (NCT02462473)
Timeframe: Week 0, Week 12

Interventionunits on a scale (Number)
Participant 1 (Week 0)Participant 1 (Week 12)Participant 2 (Week 0)Participant 2 (Week 12)Participant 3 (Week 0)Participant 3 (Week 12)Participant 4 (Week 0)Participant 5 (Week 0)Participant 5 (Week 12)Participant 6 (Week 0)Participant 6 (Week 12)Participant 7 (Week 0)Participant 7 (Week 12)Participant 8 (Week 0)Participant 8 (Week 12)Participant 9 (Week 0)Participant 9 (Week 12)
Cohort 143434453333344333

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Changes of Quality of Life in Scores on Sheehan Disability Scale (SDS) Total

A self-reported brief scale to assess impairment of work/school, social life and family and home. Total score range of 0-30. A higher score indicates greater impairment. (NCT02720198)
Timeframe: Baseline to Week 8

Interventionscore on a scale (Mean)
Levomilnacipran-3.79
Quetiapine-0.10

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Number of Subjects With General Improvement in Scores on Clinical Global Impression Scale- Improvement (CGI-I)

CGI-I a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is used to assess the clinician's view of the patient's global functioning. Total score range of 0-7. (NCT02720198)
Timeframe: Baseline to Week 8

InterventionParticipants (Count of Participants)
Levomilnacipran21
Quetiapine24

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Number of Subjects With Global Improvement in Scores on Clinical Global Impression Scale- Severity (CGI-S)

CGI-S is a 7 point scale that assess the severity of illness and requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. It is used to assess the clinician's view of the patient's global functioning. Total score range of 0-7. (NCT02720198)
Timeframe: Baseline to Week 8

InterventionParticipants (Count of Participants)
Levomilnacipran13
Quetiapine13

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Remission Rate

Remission was defined as [>or=50% reduction in MADRS score with MADRS NCT02720198)
Timeframe: Week 8

InterventionParticipants (Count of Participants)
Levomilnacipran2
Quetiapine3

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Response Rate

Remission was defined as [>or=50% reduction in MADRS score with MADRS or=50% reduction in MADRS with MADRS >10]. Response rate included remission and response. (NCT02720198)
Timeframe: Week 8

InterventionParticipants (Count of Participants)
Levomilnacipran3
Quetiapine7

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Changes in Neurocognition by Changes in Scores on Reyes Verbal Learning Test

Number of words correctly recalled by the respondent is recorded. 1 point for each word correctly recalled. Total score range of 0-40. Higher scores mean better cognitive function. (NCT02720198)
Timeframe: Baseline to Week 8

Interventionscore on a scale (Mean)
Levomilnacipran2.28
Quetiapine2.90

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Changes in Neurocognition by Changes in Scores on Scores on Digit Symbol Substitution Test (DSST)

DSST measures working memory and visuospatial processing. 1 point for each object correctly substituted from number to each matched symbol. Total score range of 0-89. Higher scores mean better cognitive function. (NCT02720198)
Timeframe: Baseline to Week 8

Interventionscore on a scale (Mean)
Levomilnacipran3.21
Quetiapine0.87

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Changes in Scores on Apathy Evaluation Scale (AES).

Self-Administered assessment measuring lack of motivation not attributable to diminished level of consciousness, cognitive impairment, or emotional distress. Total scores range from 0-54. Higher scores indicate greater apathy. (NCT02720198)
Timeframe: Baseline to Week 8

Interventionscore on a scale (Mean)
Levomilnacipran-2.07
Quetiapine-1.83

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Changes in Sexual Dysfunction by Changes in Scores on Arizona Sexual Experience Scale (ASEX)

ASEX is scale for sexual dysfunction to assess safety and tolerability of medication. Total scores range from 5-30. Higher scores indicate greater sexual dysfunction. (NCT02720198)
Timeframe: Baseline to Week 8

Interventionscore on a scale (Mean)
Levomilnacipran-0.76
Quetiapine-0.30

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Changes of Anxiety Symptoms in Scores on Hamilton Anxiety Rating Scale (HAM-A)

A questionnaire used by clinicians to rate the severity of a patient's anxiety. Total score range of 0-48. A higher score indicates greater anxiety. (NCT02720198)
Timeframe: Baseline to Week 8

Interventionscore on a scale (Mean)
Levomilnacipran-3.89
Quetiapine-5.53

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Changes of Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score

A ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. Total scores will range from 0 to 60. Higher scores indicate greater severity of depressive episodes. (NCT02720198)
Timeframe: Baseline to Week 8

Interventionscore on a scale (Mean)
Levomilnacipran-5.81
Quetiapine-6.97

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Change in Timeline Followback of Substance Use (TLFB)

The TLFB is used to quantify self-reported drug of choice use during the past month. Counts the number of days with substance use in the past 28 days. (NCT02845453)
Timeframe: baseline, 8 weeks

InterventionDays (Mean)
Quetiapine2.3
Placebo3.3

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Change in the Number of Negative Urine Toxicology Specimens

Urine toxicology specimens for the participant's drug of choice assessed as positive or negative. For each participant, the proportion of urine toxicology specimens that are negative over the course of the trial are calculated as the number of negative specimens divided by the total number of specimens collected from week 1 until study endpoint. (NCT02845453)
Timeframe: baseline, 8 weeks

InterventionProportion of Specimens (Median)
Quetiapine0
Placebo0

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Change in Symptoms of Mania

Symptoms of mania will be assessed using the Young Mania Rating Scale (YMRS). The YMRS consists of 11 items rated on a scale. Each item is composed of 5 explicitly defined levels of severity. Severity ratings for 7 items are scored on a scale of 0 -4. The remaining 4 items are double weighted to account for poor cooperation of client when unwell and are scored on a scale of 0 - 8. Item ratings are sum to produce a total YMRS score between 0 -60. Higher scores on the YMRS indicate greater symptoms of mania. (NCT02845453)
Timeframe: baseline, 8 weeks

Interventionscore on a scale (Mean)
Quetiapine-8.8
Placebo-0.4

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Change in Symptoms of Depression

Symptoms of depression will be assessed using the Beck Depression Inventory II (BDI-II) scale. The BDI-II consists of 21 items rated on a scale from 0 (symptoms not present) to 3 (symptoms extremely severe). Total scores on the BDI-II range from 0 to 63. Higher scores indicate greater symptoms of depression. (NCT02845453)
Timeframe: baseline, 8 weeks

Interventionscore on a scale (Mean)
Quetiapine-9.1
Placebo-6.2

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Change in Craving for the Substance That the Participant Identifies as Most Problematic

Craving will be measured by the Weiss Craving Scale. This scale consists of 3 items rated on a scale from 0 (no desire/likelihood of use) to 9 (strong desire/likelihood of use). The total Weiss Craving Scale score ranges from 0 to 27. Higher scores on the Weiss Craving Scale indicate greater cravings for a substance. (NCT02845453)
Timeframe: baseline, 8 weeks

Interventionscore on a scale (Mean)
Quetiapine-1.8
Placebo0.4

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Number of Participants With Relapse

The definition of relapse is as follows 1.50% or greater increase in total DIEPSS score, 2. an increase in the total PANSS score of 25% or more from baseline, 3. deliberate self-injury, 4. emergence of clinically significant suicidal ideation, 5. violent behavior resulting in clinically significant injury to another person or property damage. (NCT03019887)
Timeframe: One year after the baseline cognitive function test or three months after the end of dose reduction, whichever came first.

InterventionParticipants (Count of Participants)
Dose Reduction130

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MADRS Response Rates

Defined as a 50% score reduction from baseline. (NCT03207438)
Timeframe: Day 4 - Week 6

,,,
InterventionParticipants (Count of Participants)
Day 4Week 1Week 2Week 4Week 6
Placebo 1 - Insomnia612314445
Placebo 1 - No Insomnia01185
Quetiapine XR 50mg - Insomnia826425964
Quetiapine XR 50mg - No Insomnia03859

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Number of Participants With 50 Percent Or Greater Reduction in the MADRS Score Over Time for the Quetiapine XR 150-300mg and Placebo 2 Arms/Groups Stratified by Depression Type (Melancholic vs. Nonmelancholic)

MADRS is the Montgomery-Asberg Depression Rating Scale. Total scores on this scale range from 0-60. However the response variable is binary coded (0 = No Response, 1 = Response). (NCT03207438)
Timeframe: 1 - 6 weeks

,,,
InterventionParticipants (Count of Participants)
Week 1Week 2Week 4Week 6
Placebo 2 - Melancholic Depression28416264
Placebo 2 - Nonmelancholic Depression47100136174
Quetiapine XR 150-300mg - Melancholic Depression63105124141
Quetiapine XR 150-300mg - Nonmelancholic Depression86195251274

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Modified MADRS Response Rates

50% score reduction from baseline calculated without Item 4 (reduced sleep). (NCT03207438)
Timeframe: 1 - 6 weeks

,,,
InterventionParticipants (Count of Participants)
Week 1Week 2Week 4Week 6
Placebo 2 - Melancholic Depression26456164
Placebo 2 - Nonmelancholic Depression46100136176
Quetiapine XR 150-300mg - Melancholic Depression5390124132
Quetiapine XR 150-300mg - Nonmelancholic Depression68179231260

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Modified MADRS Response Rate

Calculated without Item 4 (reduced sleep). (NCT03207438)
Timeframe: Day 4 - Week 6

,
InterventionParticipants (Count of Participants)
Day 4Week 1Week 2Week 4Week 6
Placebo 1611284951
Quetiapine XR 50mg622445766

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Percentage of Participants With Suicidality Assessed Using Columbia Suicide Severity Rating Scale (C-SSRS) Score

"C-SSRS is a clinician-rated instrument that reports severity and frequency of suicide-related ideation and behaviors. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (non-specific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 6 (preparatory acts or behavior), 7 (aborted attempt), 8 (interrupted attempt), 9 (actual attempt [non-fatal]), and 10 (completed suicide [only applicable for post baseline]). Minimum total score 0, maximum total score 10; higher total scores indicate more suicidal ideation and/or suicidal behavior. If no events qualify for score of 1 to 10, score of 0 was assigned (0= no event that can be assessed on the basis of C-SSRS). Higher scores indicate greater severity." (NCT03321526)
Timeframe: Up to Endpoint (Up to 24 weeks)

,
Interventionpercentage of participants (Number)
0=No Event1=Wish to be Dead2 = Non-Specific Active Suicidal Thoughts3 = Suicidal Ideation Without Plan and Intent4 = Suicidal Ideation Intent to Act Without Plan5 = Suicidal Ideation With Plan and Intent6 = Preparatory Acts or Behavior7 = Aborted Attempt8 = Interrupted Attempt9 = Actual Attempt10 = Completed Suicide
Quetiapine XR1000000000000
Seltorexant1000000000000

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Percentage of Participants With Shifts in Triglycerides From High to Very High

Percentage of participants with shifts in triglycerides from high to very high (>=200 mg/dL to <500 mg/dL at baseline to >=500 mg/dL at any post-baseline assessment) were reported. (NCT03321526)
Timeframe: Up to Week 24

Interventionpercentage of participants (Number)
Seltorexant16.7
Quetiapine XR0

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Percentage of Participants With Shifts in Triglycerides From Borderline to Very High

Percentage of participants with shifts in triglycerides from borderline to very high (>=150 mg/dL to <200 mg/dL at baseline to >=500 mg/dL at any post-baseline assessment) were reported. (NCT03321526)
Timeframe: Up to Week 24

Interventionpercentage of participants (Number)
Seltorexant0
Quetiapine XR0

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Percentage of Participants With Shifts in Triglycerides From Borderline to High

Percentage of participants with shifts in triglycerides from borderline to high (>=150 to <200 mg/dL at baseline to >=200 mg/dL at any post-baseline assessment) were reported. (NCT03321526)
Timeframe: Up to Week 24

Interventionpercentage of participants (Number)
Seltorexant25.0
Quetiapine XR37.5

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Percentage of Participants With Shifts in Fasting Blood Glucose From Normal to Borderline

Percentage of participants with shifts in fasting blood glucose from normal to borderline (<100 mg/dL at baseline to between >=100 and <126 mg/dL at any post-baseline assessment) were reported. (NCT03321526)
Timeframe: Up to Week 24

Interventionpercentage of participants (Number)
Seltorexant38.7
Quetiapine XR36.0

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Percentage of Participants With Sexual Dysfunction as Determined by Arizona Sexual Experiences Scale (ASEX) Total Score

Sexual dysfunction is defined as an ASEX total score of 19 or greater, or a score of 5 or greater on any item, or a score of 4 or greater on any 3 items. ASEX is a five-item rating scale that quantifies sex drive, arousal, vaginal lubrication/penile erection, ability to reach orgasm, and satisfaction from orgasm. Each of the 5 items is rated on a 6-point Likert scale, ranging from 1 to 6. The 5 items are summed to create a total score, ranging from 5 to 30, with the higher scores indicating more sexual dysfunction. (NCT03321526)
Timeframe: Up to Endpoint (Up to 24 weeks)

Interventionpercentage of participants (Number)
Seltorexant64.3
Quetiapine XR75.6

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Percentage of Participants With Clinically Relevant Changes in Extrapyramidal Symptoms Assessed by the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Score

The ESRS-A is an abbreviated manualized version of the ESRS, a semi-structured interview that rates parkinsonian symptoms, dystonia, dyskinesias, and akathisia over the previous 7 days. The ratings include a motor examination for rigidity, tremor, reduced facial expression or speech, impaired gait/posture, postural instability, and bradykinesia/hypokinesia. Twenty-four individual items are rated on a 6-point scale: 0=Absent, 1=Minimal, 2=Mild, 3=Moderate, 4=Severe, or 5=Extreme. Frequency is included as an index of severity. (NCT03321526)
Timeframe: Up to Endpoint (Up to 24 weeks)

Interventionpercentage of participants (Number)
Seltorexant0
Quetiapine XR0

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Percentage of Participants With Abnormalities in Electrocardiogram (ECG) Parameters

Percentage of participants with abnormalities in ECG parameters were reported. (NCT03321526)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
Seltorexant0
Quetiapine XR0

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Percentage of Participants With Abnormalities in Clinical Laboratory Parameters

Percentage of participants with abnormalities in clinical laboratory parameters were reported. (NCT03321526)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
Seltorexant0
Quetiapine XR0

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Percentage of Participants With Shifts in Fasting Blood Glucose From Borderline to High

Percentage of participants with shifts in fasting blood glucose from borderline to high (>=100 to <126 mg/dL at baseline to >=126 mg/dL at any post-baseline assessment) were reported. (NCT03321526)
Timeframe: Up to Week 24

Interventionpercentage of participants (Number)
Seltorexant9.1
Quetiapine XR25.0

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Percentage of Participants With Shifts in Triglycerides From Normal to Very High

Percentage of participants with shifts in triglycerides from normal to very high (<150 mg/dL at baseline to >=500 mg/dL at any post-baseline assessment) were reported. (NCT03321526)
Timeframe: Up to Week 24

Interventionpercentage of participants (Number)
Seltorexant0
Quetiapine XR0

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Percentage of Participants With Sustained Remission up to Week 24

Remission is defined as Montgomery-Asberg Depression Rating Scale (MADRS) total score of less than or equal to (<=) 12. A participant was defined as having achieved sustained remission if the MADRS total score was ≤12 at Week 12 and was sustained at Weeks 18 and 24. Participants with missing values at a given time point were imputed as non-evaluable for remission. MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition. (NCT03321526)
Timeframe: Up to Week 24

Interventionpercentage of participants (Number)
Seltorexant13.2
Quetiapine XR19.4

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Percentage of Participants With Sustained Response up to Week 24

A participant was defined as having achieved a sustained response if there was at least a 50% improvement from baseline in the MADRS total score at Week 12, and that response was maintained at Week 18 and Week 24. Participants who did not meet such criterion were considered as non-sustained responders. MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition. (NCT03321526)
Timeframe: Up to Week 24

Interventionpercentage of participants (Number)
Seltorexant13.2
Quetiapine XR22.2

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Percentage of Participants With Treatment-emergent Adverse Events as a Measure of Safety and Tolerability

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent AEs were AEs with onset during the double-blind treatment phase or that were a consequence of a preexisting condition that worsened since baseline. (NCT03321526)
Timeframe: Up to 24 weeks

Interventionpercentage of participants (Number)
Seltorexant65.4
Quetiapine XR80.8

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Percentage of Participants With Weight Gain of >=7% of Baseline Body Weight at Week 24

Percentage of participants with weight gain of >=7% of baseline body weight at Week 24 were reported. (NCT03321526)
Timeframe: At Week 24

Interventionpercentage of participants (Number)
Seltorexant4.3
Quetiapine XR8.5

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Time to All-Cause Discontinuation of Study Drug

Time to all-cause discontinuation of study drug is defined as the number of days from the first dose of study drug to the last dose of study drug. Participants who completed double-blind treatment were not considered to have discontinued. (NCT03321526)
Timeframe: Up to Week 24

Interventiondays (Median)
SeltorexantNA
Quetiapine XRNA

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Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) at Weeks 6, 12, and 24

The HVLT-R measures performance in verbal memory, learning, and long-term recall in which a list of words is read up to three times. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score (0 -12); the total number of true-positive errors (0-12); and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score indicates higher cognition. (NCT03321526)
Timeframe: Baseline, Weeks 6, 12, and 24

,
Interventionunits on a scale (Mean)
Total Recall: Week 6Total Recall: Week 12Total Recall: Week 24Delayed Recall: Week 6Delayed Recall: Week 12Delayed Recall: Week 24Total True-Positive Errors: Week 6Total True-Positive Errors: Week 12Total True-Positive Errors: Week 24Recognition Discrimination Index: Week 6Recognition Discrimination Index: Week 12Recognition Discrimination Index: Week 24
Quetiapine XR-0.11.31.40.61.01.4-0.4-0.1-0.71.00.1-0.3
Seltorexant0.61.92.00.20.51.30.50.20.50.8-0.30.9

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Change From Baseline in MADRS Total Score in Participants With Significant Insomnia (Baseline Insomnia Severity Index [ISI] Score >=15) Versus Those Without Significant Insomnia (Baseline ISI Score Less Than [<] 15) at Week 12

MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition. The ISI has 7 questions, each rated on a 5-point Likert scale ranging from 0 to 4. The total score is calculated as the sum of the 7 items ranging from 0 to 28. Higher scores represent a more severe condition. (NCT03321526)
Timeframe: Baseline and Week 12

,
Interventionscore on a scale (Mean)
Baseline ISI score <15Baseline ISI score >=15
Quetiapine XR-12.8-17.3
Seltorexant-10.4-13.4

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Change From Baseline in MADRS Total Score in Participants With Significant Insomnia (Baseline ISI Score >=15) Versus Those Without Significant Insomnia (Baseline ISI Score <15) at Week 18

MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition. The ISI has 7 questions, each rated on a 5-point Likert scale ranging from 0 to 4. The total score is calculated as the sum of the 7 items ranging from 0 to 28. Higher scores represent a more severe condition. (NCT03321526)
Timeframe: Baseline and Week 18

,
Interventionscore on a scale (Mean)
Baseline ISI score <15Baseline ISI score >=15
Quetiapine XR-16.2-12.9
Seltorexant-13.9-10.3

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Change From Baseline in MADRS Total Score in Participants With Significant Insomnia (Baseline ISIscore >=15) Versus Those Without Significant Insomnia (Baseline ISI Score 15) at Week 24

MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition. The ISI has 7 questions, each rated on a 5-point Likert scale ranging from 0 to 4. The total score is calculated as the sum of the 7 items ranging from 0 to 28. Higher scores represent a more severe condition. (NCT03321526)
Timeframe: Baseline and Week 24

,
Interventionscore on a scale (Mean)
Baseline ISI score <15Baseline ISI score >=15
Quetiapine XR-15.6-15.4
Seltorexant-14.3-13.5

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Change From Baseline in MADRS Total Score Over Time

MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition. (NCT03321526)
Timeframe: Baseline, Weeks 2, 4, 6, 12, 18, 24

,
Interventionscore on a scale (Mean)
Week 2Week 4Week 6Week 12Week 18Week 24
Quetiapine XR-6.4-10.8-11.4-15.6-14.1-15.4
Seltorexant-6.7-8.7-9.9-12.3-11.7-13.8

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Percentage of Participants With Abnormalities in Vital Sign Parameters

Percentage of participants with abnormalities in vital sign parameters (pulse, supine and standing blood pressure [systolic and diastolic], body temperature, and body weight) were reported. Abnormally low values for parameters included pulse (beats per minute)- decrease value from baseline (>=) 15 to <=50; Systolic Blood Pressure (BP) (mmHg [Millimeter of mercury])- decrease value from baseline >=20 to <=90; Diastolic BP- decrease value from baseline >=15 to <=50; weight (Kilogram[Kg])- decrease from baseline of >=7%; Body temperature (Celsius [C])- <35.5. Abnormally high values for parameters included pulse- increase value from baseline >=15 to >=100; Systolic BP(mmHg)- increase from baseline of >=20 to >=180; Diastolic BP- increase value from baseline >=15 to >=105; weight(Kg)- increase from baseline of >=7%; body temperature (C)- >37.5. (NCT03321526)
Timeframe: Up to 24 weeks

,
Interventionpercentage of participants (Number)
Supine Pulse Rate: Abnormally lowSupine Pulse Rate: Abnormally highStanding Pulse Rate: Abnormally lowStanding Pulse Rate: Abnormally highSupine Systolic Blood Pressure: Abnormally lowSupine Systolic Blood Pressure: Abnormally highStanding Systolic Blood Pressure: Abnormally lowStanding Systolic Blood Pressure: Abnormally highSupine Diastolic Blood Pressure: Abnormally lowSupine Diastolic Blood Pressure: Abnormally highStanding Diastolic Blood Pressure: Abnormally lowStanding Diastolic Blood Pressure: Abnormally highTemperature: Abnormally lowTemperature: Abnormally highWeight: Abnormally lowWeight: Abnormally high
Quetiapine XR2.03.905.9002.0000000008.5
Seltorexant02.002.000000002.006.04.34.3

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Percentage of Participants With Shifts in Fasting Blood Glucose From Normal to High

Percentage of participants with shifts in fasting blood glucose from normal to high (<100 mg/dL at baseline to >=126 mg/dL at any post-baseline assessment) were reported. (NCT03321526)
Timeframe: Up to Week 24

Interventionpercentage of participants (Number)
Seltorexant3.2
Quetiapine XR4.0

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Change From Baseline in MADRS Total Score Over Time, by Mode Dose

MADRS is a clinician-administered scale designed to measure depression severity and detects changes due to antidepressant treatment. The MADRS evaluates the following 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), for a total possible score range of 0-60 which is calculated by adding the scores of all 10 items. Higher scores represent a more severe condition. Negative change in score indicates improvement. (NCT03321526)
Timeframe: Baseline, Weeks 2, 4, 6, 12, 18, 24, and 26

,,,
Interventionscore on a scale (Mean)
Week 2Week 4Week 6Week 12Week 18Week 24Week 26
Quetiapine XR 150 mg-4.5-6.9-7.3-12.5-6.0-11.9-8.3
Quetiapine XR 300 mg-3.6-6.9-7.6-9.3-10.5-9.7-8.6
Seltorexant 20 mg-7.3-7.7-9.1-11.8-12.8-14.9-16.3
Seltorexant 40 mg-2.4-4.4-5.2-5.3-3.8-5.2-9.3

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Change From Baseline in MADRS-6 Score Over Time

MADRS-6 is the depression subscale of the full MADRS, including the following 6 items: apparent sadness, reported sadness, inner tension, lassitude, inability to feel, pessimistic thoughts. Each item is scored from 0 (absence of symptom) to 6 (severe symptom); the overall score ranges from 0 to 36 which is calculated by adding the scores of all 6 items. Higher scores represent a more severe condition. (NCT03321526)
Timeframe: Baseline, Weeks 2, 4, 6, 12, 18, 24, and 26

,
Interventionscore on a scale (Mean)
Week 2Week 4Week 6Week 12Week 18Week 24Week 26
Quetiapine XR-4.1-6.9-7.5-10.4-9.2-10.3-8.4
Seltorexant-4.4-5.8-6.7-7.5-7.2-9.1-9.1

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Change From Baseline in Patient Reported Outcomes Measurement Information System-Sleep Disturbance (PROMIS-SD) Short Form 8a at Weeks 12 and 24

The PROMIS-SD Short Form 8a subscale consists of a static 8 item questionnaire. It assesses the concepts of sleep initiation (2 items), quality of sleep (3 items), early morning feelings (2 items) and worrying about sleep (1 item). Responses to each of the 8 items range from 1 to 5, and the range of possible summed raw scores is 8 to 40. Higher scores on the PROMIS-SD indicate more of the concept measured (disturbed sleep). Negative change in score indicates improvement. (NCT03321526)
Timeframe: Baseline, Weeks 12 and 24

,
Interventionunits on a scale (Mean)
Week 12Week 24
Quetiapine XR-11.87-12.91
Seltorexant-8.22-11.45

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Change From Baseline in Quality of Life in Depression Scale (QLDS) Score at Weeks 12 and 24

"The QLDS is a disease specific patient-reported outcome (PRO) designed to assess health related quality of life in participants with major depressive disorder (MDD). The instrument has a recall period of at the present time, contains 34-items with true/not true response options. Each statement on the QLDS is given a score of 1 (adverse quality of life) or 0 good quality of life. All item scores are summed to give a total score that ranges from 0 (good quality of life) to 34 (very poor quality of life). A higher score indicates a more severe condition. Negative change indicates improvement." (NCT03321526)
Timeframe: Baseline, Weeks 12 and 24

,
Interventionunits on a scale (Mean)
Week 12Week 24
Quetiapine XR-8.3-9.9
Seltorexant-8.1-9.5

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Change From Baseline in Salivary Cortisol Levels as Measured at Home Upon Awakening and During the Evening at Weeks 6 and 24

Change from baseline in salivary cortisol levels as measured upon awakening and at home during the evening at Weeks 6 and 24 were reported. (NCT03321526)
Timeframe: Baseline, Weeks 6 and 24

,
Interventionnanomoles per liter (nmol/L) (Mean)
Awakening: Week 6Awakening: Week 24Evening: Week 6Evening: Week 24
Quetiapine XR-2.8-1.70.50.9
Seltorexant1.31.4-0.71.4

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Change From Baseline in Symbol Digit Modalities Test (SDMT) at Weeks 6, 12, and 24

SDMT is a widely used, paper-and-pencil assessment of complex scanning and visual tracking, requiring elements of attention, visuoperceptual processing, working memory, and cognitive/psychomotor speed. The test is viewed as a robust screening test for adult neuropsychological impairment and is sensitive to impairments in cognitive function associated with MDD. The SDMT measured the time to pair abstract symbols with specific numbers. The test included a coding key consisting of 9 abstract symbols, each paired with a number ranging from 1 to 9. Following the key, the participant was presented with randomly ordered symbols and was required to write the number corresponding to each symbol as fast as possible. The number of correct substitutions within 90 seconds was recorded and total score derived from the total number of correct responses with a minimum possible score of 0 and maximum of 110 where high scores indicate better outcome. Positive change in score indicates improvement. (NCT03321526)
Timeframe: Baseline, Weeks 6, 12, and 24

,
Interventionunits on a scale (Mean)
Week 6Week 12Week 24
Quetiapine XR-2.90.10.0
Seltorexant5.05.54.7

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Change From Baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) Score at Weeks 12 and 24

"The SMDDS assesses participant-reported symptoms associated with MDD. This 16-item instrument has a 7-day recall period, and participants respond to each question using a rating scale between 0 (Not at all or Never) to 4 (Extremely or Always). Before summing the items to create a total score, item 11 (how often did you have a poor appetite) and item 12 (how often did you over eat) are combined into a single score by selecting the highest severity on either item. The total score is then created by summing the responses on the 15 items. The total score ranges from 0 to 60 with a higher score indicating more severe depressive symptomatology. Negative change in score indicates improvement." (NCT03321526)
Timeframe: Baseline, Weeks 12 and 24

,
Interventionunits on a scale (Mean)
Week 12Week 24
Quetiapine XR-15.7-19.6
Seltorexant-13.9-15.6

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Percentage of Participants With Shifts in Triglycerides From Normal to High

Percentage of participants with shifts in triglycerides from normal to high (<150 milligrams per deciliter [mg/dL] at baseline to >=200 mg/dL at any post-baseline assessment) were reported. (NCT03321526)
Timeframe: Up to Week 24

Interventionpercentage of participants (Number)
Seltorexant7.1
Quetiapine XR13.6

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Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Scale Score at Weeks 12 and 24

The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S is a 7-point global assessment scale that measures the clinician's impression of the severity of illness exhibited by a participant, rating according to: 1=normal (not at all ill); 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; and 7=among the most extremely ill participants. Higher scores indicate worsening. Negative change in score indicates improvement. (NCT03321526)
Timeframe: Baseline, Weeks 12 and 24

,
Interventionunits on a scale (Mean)
Week 12Week 24
Quetiapine XR-1.7-1.7
Seltorexant-1.2-1.4

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Change From Baseline in the Hamilton Anxiety Rating Scale (HAM-A) Total Score at Weeks 12, 18, and 24

HAM-A is a 14-item scale designed to measure anxiety in individuals. Each question reflects a symptom of anxiety and physical as well as mental symptoms are represented. Each of the 14-items in the scale is scored on a 5-point scale, ranging from 0 (a complete lack of that symptom) to 4 (a very severe show of anxiety with that symptom). The total score ranges from 0 to 56 which is calculated by adding the scores of all 14 items, where 0-13 indicates normal range, 14-17 indicates mild severity, 18 -24: mild to moderate severity, 25 -30: moderate to severe, and >=31: severe. Higher score indicates worsening. Negative change in score indicates improvement. (NCT03321526)
Timeframe: Baseline, Weeks 12, 18, and 24

,
Interventionunits on a scale (Mean)
Week 12Week 18Week 24
Quetiapine XR-6.6-10.0-9.5
Seltorexant-8.7-8.5-10.9

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Change From Baseline in the Patient Global Impression Severity (PGI-S) Scale Score at Weeks 12 and 24

The PGI-S is a self-report scale to measure severity of illness (1=none, 2=mild, 3=moderate, 4=severe). Higher score indicates more illness severity. Negative change in score indicates improvement. (NCT03321526)
Timeframe: Baseline, Weeks 12 and 24

,
Interventionunits on a scale (Mean)
Week 12Week 24
Quetiapine XR-1.1-1.5
Seltorexant-1.0-1.2

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Change From Baseline in Trail Making Test - Part B (TMT-Part B) at Weeks 6, 12, and 24

The TMT-Part B measures divided attention and executive function (tracking and sequencing). The participant is instructed to draw a line to connect a set of 25 consecutively numbered and lettered circles, alternating sequentially between numbers and letters (that is, 1 A 2 B). The participant is instructed to work as quickly as possible while still maintaining accuracy. Score included time (seconds) to completion and number of errors in performing the test which ranges from 0 (no errors) to 25 (more errors), where shorter time and less number of errors indicates better performance. The TMT-Part B is sensitive to cognitive decline associated with MDD. Negative change in score indicates improvement. (NCT03321526)
Timeframe: Baseline, Weeks 6, 12, and 24

,
Interventionunits on a scale (Mean)
Week 6Week 12Week 24
Quetiapine XR0.00.6-0.3
Seltorexant0.40.20.5

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Percentage of Participant With Potential Withdrawal Effects Assessed by the Physician Withdrawal Checklist (PWC)

Intensity of discontinuation symptoms was assessed (anxiety-nervousness, dysphoric mood/depression, Depersonalization-Derealization, , Diaphoresis, Diarrhea, Difficulty Concentrating, Remember, Dizziness-Lightheadedness, Fatigue-Lethargy-Lack of Energy, Headaches, Increased Acuity Sound Smell Touch, Irritability, Loss of Appetite, Muscle Aches or Stiffness, Nausea-Vomiting, Paresthesias, Poor Coordination, Restlessness-Agitation, Tremor-Tremulousness, Weakness), using the Physician Withdrawal Checklist (PWC-20) administered by a trained clinician/rater. Symptoms are rated on a scale of 0 (no symptom present), 1 (mild), 2 (moderate), and 3 (severe). Total scores range from 0 (no symptom) to 24 (severe symptom) calculated by adding the scores of following 8 items: Nausea-Vomiting, Diarrhea, Poor Coordination, Diaphoresis, Tremor-Tremulousness, Dizziness-Lightheadedness, Increased Acuity Sound Smell Touch, Paresthesias. Higher scores indicates more severe symptoms. (NCT03321526)
Timeframe: Up to 26 weeks

,
Interventionpercentage of participants (Number)
Anxiety-Nervousness present (Endpoint [DB])Anxiety-Nervousness present (Follow-up)Depersonalization-Derealization present (Endpoint [DB])Depersonalization-Derealization present (Follow-up)Diaphoresis present (Endpoint [DB])Diaphoresis present (Follow-up)Diarrhea present (Endpoint [DB])Diarrhea present (Follow-up)Difficulty Concentrating, Remembering present (Endpoint [DB])Difficulty Concentrating, Remembering present (Follow-up)Dizziness-Lightheadedness present (Endpoint [DB])Dizziness-Lightheadedness present (Follow-up)Dysphoric Mood-Depression present (Endpoint [DB])Dysphoric Mood-Depression present (Follow-up)Fatigue-Lethargy-Lack of Energy present (Endpoint[DB])Fatigue-Lethargy-Lack of Energy present (Follow-up)Headaches present (Endpoint [DB])Headaches present (Follow-up)Increased Acuity for Sound, Smell, Touch, or Pain present (Endpoint [DB])Increased Acuity for Sound, Smell, Touch, or Pain present (Follow-up)Insomnia present (Endpoint [DB])Insomnia present (Follow-up)Irritability present (Endpoint [DB])Irritability present (Follow-up)Loss of Appetite present (Endpoint [DB])Loss of Appetite present (Follow-up)Muscle Aches or Stiffness present (Endpoint [DB])Muscle Aches or Stiffness present (Follow-up)Nausea-Vomiting present (Endpoint [DB])Nausea-Vomiting present (Follow-up)Paresthesias present (Endpoint [DB])Paresthesias present (Follow-up)Poor Coordination present (Endpoint [DB])Poor Coordination present (Follow-up)Restlessness-Agitation present (Endpoint [DB])Restlessness-Agitation present (Follow-up)Tremor-Tremulousness present (Endpoint [DB])Tremor-Tremulousness present (Follow-up)Weakness present (Endpoint [DB])Weakness present (Follow-up)
Quetiapine XR33.353.600010.7014.3039.333.385.766.760.766.739.333.332.107.166.746.466.725.066.721.433.314.3017.903.633.385.733.310.733.314.333.314.3
Seltorexant75.033.306.706.700026.7023.350.040.050.033.3016.706.775.033.375.023.325.010.050.016.703.303.325.010.025.026.703.325.03.3

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Percentage of Participants With Treatment-emergent Serious Adverse Events (SAEs) and Events of Special Interest

An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence that at any dose may result in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product. AESIs were significant AEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Adverse events of special interest were cataplexy, sleep paralysis, complex, and sleep-related behaviors (parasomnias). (NCT03321526)
Timeframe: Up to 24 weeks

,
Interventionpercentage of participants (Number)
SAEsAESIs
Quetiapine XR3.85.8
Seltorexant1.913.5

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Number of Participants With Clinically Significant Differences in Simpson Angus Scale (SAS) Values

SAS scale consists of 10 items including 7 items that address bradykinesia-rigidity and additional single items for tremor, glabellar tap, and salivation. Each item represents a specific physical condition and is rated on a 5-point category rating scale ranging from 0 (complete absence of the condition) to 4 (the condition is present to an extreme degree).The total score is obtained by adding the scores for the 10 individual items making the maximum possible score is 40. Higher scores are indicative of more severe Parkinsonian-type symptoms. (NCT03557931)
Timeframe: Baseline, week 6 and week 12

,,
Interventionparticipants (Number)
BaselineWeek 6Week 12
ASP4345 150 mg000
ASP4345 50 mg000
Placebo000

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Number of Participants With Clinically Significant Differences in Barnes Akathisia Rating Scale (BARS) Values

BARS is used to rate observable, restless movements of drug induced akathisia and subjective awareness of restlessness and any distress associated with the akathisia. BARS consists of the following 4 items: objective assessment of akathisia symptoms, subjective assessment of the participants's awareness of inner restlessness, distress restlessness, and global clinical assessment of akathisia. First three items are rated on a 4-point scale ranging from 0 (no abnormal movements or absence of inner restlessness or no distress) to 3 (severe akathisia or awareness of intense compulsion to move most of the time or severe distress). The last item, the global clinical assessment of akathisia, is rated on a 6-point scale, ranging from 0 (no evidence of akathisia) to 5 (severe akathisia). Total BARS score ranges from 0 to 14 with a higher score representing worse results. (NCT03557931)
Timeframe: Baseline, week 6 and week 12

,,
Interventionparticipants (Number)
BaselineWeek 6Week 12
ASP4345 150 mg000
ASP4345 50 mg000
Placebo000

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Change From Baseline to Week 12/End of Treatment (EoT) in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Neurocognitive Composite Score

The MCCB is a cognitive battery to assess 7 domains recommended by the MATRICS initiative (i.e., working memory, verbal learning, speed of processing, attention/vigilance, visual learning, social cognition, reasoning and problem solving). The MCCB neurocognitive composite score is a standardized mean of the six domain scores (excluding social cognition). Raw scores are converted to age and sex adjusted t-scores which are standardized to normative data, and have a mean of 50 and standard deviation of 10 in the general healthy population. A higher score indicates less impairment. (NCT03557931)
Timeframe: Baseline and week 12/end of treatment (EoT)

InterventionT-score (Least Squares Mean)
Placebo1.15
ASP4345 50 mg1.34
ASP4345 150 mg0.87

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Number of Participants With Clinically Significant Differences in Columbia-Suicide Severity Rating Scale (C-SSRS) Values

The C-SSRS is a questionnaire used for suicide risk assessment. Affirmative or negative responses are provided to items 1 to 5 for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods [not plan] without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and items 6 to 10 for suicide behavior (6. Preparatory acts or behavior, 7. Aborted attempt, 8. Interrupted attempt, 9. Actual attempt, 10. Completed suicide). (NCT03557931)
Timeframe: Baseline up to EoS (week 14)

Interventionparticipants (Number)
Placebo0
ASP4345 50 mg0
ASP4345 150 mg0

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Number of Participants With Clinically Significant Differences in Abnormal Involuntary Movement Scale (AIMS) Values

AIMS is a 14-item scale. Items 1 to 8 are rated on a 5-point scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Item 9 assesses the participant's incapacitation due to abnormal movements, and item 10 assesses the participant's awareness of the abnormal movements and associated distress. Items 9 and 10 are rated on 5-point scales ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Items 11 to 14 are yes/no questions regarding the global judgement and dental status of the participant. The total score is the sum of the scores for the 14 items and the possible total score ranges from 0 to 44. A higher total score is indicative of more severe dyskinetic movements. (NCT03557931)
Timeframe: Baseline, week 6 and week 12

,,
Interventionparticipants (Number)
BaselineWeek 6Week 12
ASP4345 150 mg000
ASP4345 50 mg000
Placebo000

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Number of Participants With Adverse Event (AE)

Treatment emergent adverse event (TEAE) is defined as an AE observed after starting administration of the study drug and 28 days after the last dose of study drug. A study drug-related TEAE is defined as any TEAE with at least possible relationship to study treatment as assessed by the investigator or with missing assessment of the causal relationship. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Safety was assessed by AEs, which included abnormalities identified during a medical test (e.g. laboratory tests, vital signs, electrocardiogram, metabolic parameters etc.) if the abnormality induced clinical signs or symptoms, needed active intervention, interruption or discontinuation of study medication or was clinically significant. (NCT03557931)
Timeframe: Baseline up to end of study (EoS) (week 14)

,,
Interventionparticipants (Number)
TEAEDrug-Related TEAEsSerious TEAEsDrug-Related Serious TEAE
ASP4345 150 mg281110
ASP4345 50 mg281330
Placebo451110

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Concentration at Trough Level (Ctrough) for ASP4345

Ctrough concentration for ASP4345 was reported. (NCT03557931)
Timeframe: Predose: day 7, day 14, day 21, day 42 and day 84/EoT

,
Interventionnanogram per milliliter (ng/mL) (Mean)
Day 7 Pre-doseDay 14 Pre-doseDay 21 Pre-doseDay 42 Pre-doseDay 84 Pre-dose
ASP4345 150 mg483.84428.88384.48471.78433.56
ASP4345 50 mg175.041182.903172.040207.145204.914

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Change From Baseline to Week 12/EoT in University of California San Diego Performance-based Skills Assessment-2 Extended Range (UPSA-2-ER) Total Score

The UPSA-2-ER assesses the functional abilities of the participant with schizophrenia in 6 domains: household management, communication, financial skills, transportation, comprehension/planning and medication management. The UPSA-2-ER total score has a range from 0 to 105. A higher score indicates less impairment. (NCT03557931)
Timeframe: Baseline and week 12/EoT

Interventionunits on a scale (Least Squares Mean)
Placebo3.11
ASP4345 50 mg3.86
ASP4345 150 mg2.56

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Percentage Of Days With Good Patch Coverage

The DMS includes a drug-device combination of a CoE product, a wearable sensor patch, and application software (smartphone) to record activity and rest and mark events through the act of ingestion. The CoE product consists of an approved antipsychotic medication enclosed with an Ingestible Sensor Pill (miniature ingestible event marker in tablet [MIT]). The sensor patch detects and records each MIT ingestion, as well as other physiologic and behavioral data. Good patch coverage for a specific day was defined as having either at least 80% patch data available (80% of the day the patch was worn and data was collected as noted via the accelerometer channel) or the MIT was detected within the 24-hour period, for each day while the participant was in the trial. The percentage of days was calculated as the number of days with good patch coverage divided by the total number of trial days for each participant. Descriptive statistics were performed for this outcome measure. (NCT03568500)
Timeframe: Up to 8 weeks

Interventionpercentage of days (Mean)
Schizophrenia64.34
Schizoaffective Disorder62.99
First Episode Psychosis62.51
Total63.37

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Participant Adherence

The DMS includes a drug-device combination of a CoE product, a wearable sensor patch, and application software (smartphone) to record activity and rest and mark events through the act of ingestion. The CoE product consists of an approved antipsychotic medication enclosed with an Ingestible Sensor Pill (MIT). The sensor patch detects and records each MIT ingestion, as well as other physiologic and behavioral data. Participant adherence was measured as the detected MITs over the expected MITs ingested during the trial days with good patch coverage. The more the participant successfully engaged in a number of processes across the 8-week trial, the greater the measured adherence. Descriptive statistics were performed for this outcome measure. (NCT03568500)
Timeframe: Up to 8 weeks

Interventionpercentage of MITs (Mean)
Schizophrenia88.94
Schizoaffective Disorder72.29
First Episode Psychosis91.04
Total86.57

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Treatment-emergent Adverse Events (TEAEs)

Assess the safety and tolerability of pimavanserin in patients with PD in terms of treatment-emergent adverse events. (NCT04164758)
Timeframe: 4-week treatment duration, plus 30 days treatment-free safety follow-up

InterventionParticipants (Count of Participants)
Placebo1
Quetiapine3
Pimavanserin 34 mg1

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Change From Baseline in Participant-reported HRQoL and Health Status as Assessed by SF-36 Scale Score at LOCF

Change from baseline in participant-reported HRQoL and health status as assessed by SF-36 domain scores at LOCF was reported. The SF-36 consists of 8 subscales (physical function, role limitations due to physical problems, pain, general health perception, vitality, social function, role limitations due to emotional problems, and mental health). Participants self-report on items in a subscale that have between 2-6 choices per item using likert-type responses (for example: none of the time, some of the time, etc.). Summations of item scores of the same subscale give the subscale scores, which are transformed into a range from 0 to 100; 0= worst HRQoL, 100=best HRQoL. Higher scores indicate better health status. LOCF is defined as participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward. (NCT04338321)
Timeframe: Baseline, LOCF at Weeks 8, 12, 16, 20, 24, 28, 32

,
InterventionUnits on scale (Mean)
Physical Functioning Week 8Physical Functioning Week 12Physical Functioning Week 16Physical Functioning Week 20Physical Functioning Week 24Physical Functioning Week 28Physical Functioning Week 32Role-Physical Week 8Role-Physical Week 12Role-Physical Week 16Role-Physical Week 20Role-Physical Week 24Role-Physical Week 28Role-Physical Week 32Body Pain Week 8Body Pain Week 12Body Pain Week 16Body Pain Week 20Body Pain Week 24Body Pain Week 28Body Pain Week 32General Health Week 8General Health Week 12General Health Week 16General Health Week 20General Health Week 24General Health Week 28General Health Week 32Vitality Week 8Vitality Week 12Vitality Week 16Vitality Week 20Vitality Week 24Vitality Week 28Vitality Week 32Social Functioning Week 8Social Functioning Week 12Social Functioning Week 16Social Functioning Week 20Social Functioning Week 24Social Functioning Week 28Social Functioning Week 32Role-Emotional Week 8Role-Emotional Week 12Role-Emotional Week 16Role-Emotional Week 20Role-Emotional Week 24Role-Emotional Week 28Role-Emotional Week 32Mental Health Week 8Mental Health Week 12Mental Health Week 16Mental Health Week 20Mental Health Week 24Mental Health Week 28Mental Health Week 32
Esketamine Nasal Spray + Oral Antidepressant (AD)5.15.35.65.55.65.66.07.48.39.39.19.29.410.24.44.85.25.25.65.46.06.97.48.08.18.28.69.211.111.712.312.312.212.813.810.711.412.212.312.713.014.012.012.714.214.314.315.216.012.914.014.715.014.815.516.3
Quetiapine Extended Release (XR) + Oral AD3.23.94.24.04.44.54.65.35.76.26.36.96.87.23.54.24.34.54.44.55.04.95.15.65.55.66.16.77.88.79.59.69.610.110.47.68.69.09.19.59.810.38.69.810.310.411.211.211.29.810.610.911.211.512.212.6

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Change From Baseline in Participant-reported Quality of Life as Assessed by QLDS Total Score at LOCF

"Change from baseline in participant-reported quality of life as assessed by QLDS total score at LOCF was reported. The QLDS is a disease-specific validated PRO measure which assesses the impact that depression has on a participant's quality of life. It is a 34-item self-rated questionnaire which consists of dichotomous response questions, with the response being either True/Not True. Each statement on the QLDS is given a score of 1 or 0. A score of 1 is indicative of adverse quality of life. All item scores are summed to give a total score that ranges from 0 (good quality of life) to 34 (very poor quality of life). A higher score indicates a more severe condition. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward." (NCT04338321)
Timeframe: Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32

,
InterventionUnits on Scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32
Esketamine Nasal Spray + Oral Antidepressant (AD)-8.9-11.3-12.3-13.0-13.0-13.3-13.6-14.1
Quetiapine Extended Release (XR) + Oral AD-5.6-8.1-9.0-9.3-9.5-9.8-10.3-10.5

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Change From Baseline in Participant-reported Quality of Life as Assessed by Quality of Life in Depression Scale (QLDS) Total Score

"Change from baseline in participant-reported quality of life as assessed by QLDS total score was reported. The QLDS is a disease-specific validated PRO measure which assesses the impact that depression has on a participant's quality of life. It is a 34-item self-rated questionnaire which consists of dichotomous response questions, with the response being either True/Not True. Each statement on the QLDS is given a score of 1 or 0. A score of 1 is indicative of adverse quality of life. All item scores are summed to give a total score that ranges from 0 (good quality of life) to 34 (very poor quality of life). A higher score indicates a more severe condition." (NCT04338321)
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32

,
InterventionUnits on Scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32
Esketamine Nasal Spray + Oral Antidepressant (AD)-8.9-12.0-13.5-14.2-14.3-14.9-15.6-16.0
Quetiapine Extended Release (XR) + Oral AD-5.6-9.1-10.9-11.6-12.1-12.8-13.7-14.2

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Change From Baseline in Participant-reported Work Productivity as Assessed by WPAI: Depression Questionnaire at LOCF

Change from baseline in participant-reported work productivity as assessed by WPAI: depression questionnaire at LOCF was reported. The WPAI-D questionnaire is a validated short instrument that assesses impairment in work and other regular activities over the past 7 days. The WPAI yields four types of scores: (a) Absenteeism (work time missed); (b) Presenteeism (impairment at work / reduced on-the-job effectiveness); (c) Work productivity loss (overall work impairment / absenteeism plus presenteeism); (d) Activity Impairment. The first three scores were derived only for respondents who were working (should be missing for non-working), but the last score was applicable for all respondents. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward. (NCT04338321)
Timeframe: Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32

,
InterventionUnits on scale (Mean)
Absenteeism Week 4Absenteeism Week 8Absenteeism Week 12Absenteeism Week 16Absenteeism Week 20Absenteeism Week 24Absenteeism Week 28Absenteeism Week 32Presenteeism Week 4Presenteeism Week 8Presenteeism Week 12Presenteeism Week 16Presenteeism Week 20Presenteeism Week 24Presenteeism Week 28Presenteeism Week 32Work productivity loss Week 4Work productivity loss Week 8Work productivity loss Week 12Work productivity loss Week 16Work productivity loss Week 20Work productivity loss Week 24Work productivity loss Week 28Work productivity loss Week 32Activity Impairment Week 4Activity Impairment Week 8Activity Impairment Week 12Activity Impairment Week 16Activity Impairment Week 20Activity Impairment Week 24Activity Impairment Week 28Activity Impairment Week 32
Esketamine Nasal Spray + Oral Antidepressant (AD)-11.95-18.28-20.23-21.35-25.45-24.41-23.88-26.10-21.75-29.45-33.57-35.00-36.08-36.87-37.40-40.53-20.94-30.59-34.46-36.35-37.59-39.02-39.09-43.42-20.29-28.84-31.10-31.84-30.84-32.45-34.87-36.65
Quetiapine Extended Release (XR) + Oral AD-8.37-12.38-15.17-14.14-16.04-16.28-14.14-13.90-9.13-14.84-17.44-19.84-21.41-22.19-23.83-23.44-9.462-15.35-19.27-20.75-22.58-22.54-23.85-24.89-13.43-20.39-22.81-23.68-23.62-26.71-27.07-28.40

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Clinician-rated Overall Severity of Depressive Illness as Assessed by Clinical Global Impression - Change (CGI-C) Scale Score

Clinician-rated overall severity of depressive illness as assessed by CGI-C scale score was reported. The CGI-C evaluates the total improvement whether or not entirely due to drug treatment on a scale of 1 to 7. Compared to the condition at baseline, a participant is assessed on how much he/she has changed, according to: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse. Higher scores indicate more severity. (NCT04338321)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32

,
InterventionUnits on scale (Mean)
Week 1Week 2Week 3Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32
Esketamine Nasal Spray + Oral Antidepressant (AD)3.32.92.72.42.12.01.91.81.81.71.6
Quetiapine Extended Release (XR) + Oral AD3.63.33.12.92.42.32.22.12.02.01.9

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Number of Participants With Clinician-rated Overall Severity of Depressive Illness as Assessed by CGI-C Scale Score at LOCF

Number of participants with clinician-rated overall severity of depressive illness as assessed by CGI-C scale score at LOCF was reported. The CGI-C evaluates the total improvement whether or not entirely due to drug treatment on a scale of 1 to 7. Compared to the condition at baseline, a participant is assessed on how much he/she has changed, according to: 1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse. Higher scores indicate more severity. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward. (NCT04338321)
Timeframe: Baseline, LOCF at Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 32

,
InterventionParticipants (Count of Participants)
Very much improved at Week 2Much improved at Week 2Minimally improved at Week 2No change at Week 2Minimally worse at Week 2Much worse at Week 2Very much worse at Week 2Very much improved at Week 3Much improved at Week 3Minimally improved at Week 3No change at Week 3Minimally worse at Week 3Much worse at Week 3Very much worse at Week 3Very much improved at Week 4Much improved at Week 4Minimally improved at Week 4No change at Week 4Minimally worse at Week 4Much worse at Week 4Very much worse at Week 4Very much improved at Week 8Much improved at Week 8Minimally improved at Week 8No change at Week 8Minimally worse at Week 8Much worse at Week 8Very much worse at Week 8Very much improved at Week 12Much improved at Week 12Minimally improved at Week 12No change at Week 12Minimally worse at Week 12Much worse at Week 12Very much worse at Week 12Very much improved at Week 16Much improved at Week 16Minimally improved at Week 16No change at Week 16Minimally worse at Week 16Much worse at Week 16Very much worse at Week 16Very much improved at Week 20Much improved at Week 20Minimally improved at Week 20No change at Week 20Minimally worse at Week 20Much worse at Week 20Very much worse at Week 20Very much improved at Week 24Much improved at Week 24Minimally improved at Week 24No change at Week 24Minimally worse at Week 24Much worse at Week 24Very much worse at Week 24Very much improved at Week 28Much improved at Week 28Minimally improved at Week 28No change at Week 28Minimally worse at Week 28Much worse at Week 28Very much worse at Week 28Very much improved at Week 32Much improved at Week 32Minimally improved at Week 32No change at Week 32Minimally worse at Week 32Much worse at Week 32Very much worse at Week 32
Esketamine Nasal Spray + Oral Antidepressant (AD)697141756111412613545601411501022940168165681852183156532491110013658255211061375519721123123482561112712146247111481034228411
Quetiapine Extended Release (XR) + Oral AD43914910826508571598120601783152521710038118105441610045120924718905511184492390611108349199064109864419907110480481990829681432090

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Change From Baseline in Clinician-rated Overall MADRS Score at Last Observation Carried Forward (LOCF)

Change from baseline in clinician-rated overall MADRS score at LOCF was reported. The MADRS is a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of the symptoms), summed up for a total possible score range of 0 to 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward. (NCT04338321)
Timeframe: Baseline, LOCF at Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32

,
InterventionUnit on scale (Mean)
Week 2Week 4Week 6Week 8Week 10Week 12Week 14Week 16Week 18Week 20Week 22Week 24Week 26Week 28Week 30Week 32
Esketamine Nasal Spray + Oral Antidepressant (AD)-9.0-12.6-14.5-15.7-16.9-17.1-17.6-18.1-18.1-18.2-18.7-18.8-19.0-19.1-19.2-19.6
Quetiapine Extended Release (XR) + Oral AD-5.8-8.9-10.7-12.0-12.8-13.1-13.2-13.7-13.8-14.3-14.6-14.8-14.9-15.2-15.2-15.1

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Change From Baseline in Clinician-rated Overall MADRS Score

Change from baseline in clinician-rated overall MADRS score was reported. The MADRS is a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of the symptoms), summed up for a total possible score range of 0 to 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts. (NCT04338321)
Timeframe: Baseline, Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32

,
InterventionUnit on scale (Mean)
Week 1Week 2Week 4Week 6Week 8Week 10Week 12Week 14Week 16Week 18Week 20Week 22Week 24Week 26Week 28Week 30Week 32
Esketamine Nasal Spray + Oral Antidepressant (AD)-5.3-9.0-12.8-14.9-16.4-18.2-18.4-19.0-19.6-19.9-20.1-20.6-21.0-21.2-21.5-21.8-22.2
Quetiapine Extended Release (XR) + Oral AD-3.7-6.1-9.8-12.2-14.3-16.2-16.7-17.1-17.8-18.1-19.1-19.5-20.1-20.0-20.8-20.6-20.5

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Change From Baseline in Participant-reported Depressive Symptoms as Assessed by PHQ 9-item Total Score at LOCF

Change from baseline in participant-reported depressive symptoms as assessed by PHQ 9-item total score at LOCF was reported. The PHQ-9 is a validated 9-item, PRO measure to assess depressive symptoms. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19) and Severe (20-27). LOCF is defined as participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward. (NCT04338321)
Timeframe: Baseline, LOCF at Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32

,
InterventionUnits on scale (Mean)
Week 2Week 4Week 6Week 8Week 10Week 12Week 14Week 16Week 18Week 20Week 22Week 24Week 26Week 28Week 30Week 32
Esketamine Nasal Spray + Oral Antidepressant (AD)-4.9-6.6-7.8-8.5-9.0-9.1-9.3-9.6-9.5-9.4-9.7-9.5-9.7-9.7-9.9-10.1
Quetiapine Extended Release (XR) + Oral AD-3.1-4.7-5.6-6.3-7.0-7.1-6.9-7.4-7.3-7.4-7.5-7.5-7.5-7.6-7.6-8.0

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Change From Baseline in Participant-reported Depressive Symptoms as Assessed by Patient Health Questionnaire (PHQ) 9-item Total Score

Change from baseline in participant-reported depressive symptoms as assessed by PHQ 9-item total score was reported. The PHQ-9 is a validated 9-item, patient-reported outcome (PRO) measure to assess depressive symptoms. Each item is rated on a 4-point scale (0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27), with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19) and Severe (20-27). (NCT04338321)
Timeframe: Baseline, Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32

,
InterventionUnits on scale (Mean)
Week 2Week 4Week 6Week 8Week 10Week 12Week 14Week 16Week 18Week 20Week 22Week 24Week 26Week 28Week 30Week 32
Esketamine Nasal Spray + Oral Antidepressant (AD)-4.9-6.7-8.1-8.9-9.6-9.8-10.2-10.5-10.6-10.4-10.7-10.6-10.9-10.9-11.2-11.4
Quetiapine Extended Release (XR) + Oral AD-3.1-5.0-6.1-7.4-8.4-8.7-8.5-9.2-9.3-9.4-9.5-9.7-9.7-10.0-10.1-10.5

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Number of Participants With TEAEs of Special Interest

Number of participants with TEAEs of special interest were reported. It included significant TEAEs that were judged to be of special interest because of clinical importance, known or suspected class effects, or based on nonclinical signals. Events such as sedation, depersonalization/derealization disorder, depression suicidal, aggression, allergic cystitis, cholestasis and jaundice of hepatic origin, and many more were considered as TEAEs of special interest. (NCT04338321)
Timeframe: Up to Week 35

InterventionParticipants (Count of Participants)
Esketamine Nasal Spray + Oral Antidepressant (AD)223
Quetiapine Extended Release (XR) + Oral AD140

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Change From Baseline in Clinician-rated Overall Severity of Depressive Illness as Assessed by Clinical Global Impression - Severity (CGI-S) Scale Score

Change from baseline in clinician-rated overall severity of depressive illness as assessed by CGI-S scale score was reported. The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 1 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 1 = normal (not at all ill); 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. Negative change in score indicates improvement. (NCT04338321)
Timeframe: Baseline, Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32

,
InterventionUnits on scale (Mean)
Week 1Week 2Week 3Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32
Esketamine Nasal Spray + Oral Antidepressant (AD)-0.3-0.7-1.0-1.3-1.7-1.9-2.1-2.2-2.3-2.4-2.5
Quetiapine Extended Release (XR) + Oral AD-0.2-0.5-0.7-1.0-1.4-1.7-1.9-2.0-2.1-2.2-2.3

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Change From Baseline in Participant-reported Functional Impairment and Associated Disability as Assessed by SDS Total Score at LOCF

Change from baseline in participant-reported functional impairment and associated disability as assessed by SDS total score at LOCF was reported. The SDS is a validated PRO measure consisting of a 5-item questionnaire for assessment of functional impairment and associated disability. The first 3 items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a rating scale from 0 to 10. It also has 1 item assessing days lost from school or work and 1 item assessing days of underproductivity. The scores for the first 3 items are summed to create a total score of 0 to 30, where higher score indicates greater impairment. Scores <=2 for each item and <= 6 for the total score are considered functional remission. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward. (NCT04338321)
Timeframe: Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32

,
InterventionUnits on scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32
Esketamine Nasal Spray + Oral Antidepressant (AD)-5.9-8.2-9.0-9.8-9.9-10.0-10.4-11.1
Quetiapine Extended Release (XR) + Oral AD-4.1-5.8-6.8-7.0-7.0-7.6-7.9-8.2

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Change From Baseline in Participant-reported Functional Impairment and Associated Disability as Assessed by Sheehan Disability Scale (SDS) Total Score

Change from baseline in participant-reported functional impairment and associated disability as assessed by SDS total score was reported. The SDS is a validated PRO measure consisting of a 5-item questionnaire that has been widely used and accepted for assessment of functional impairment and associated disability. The first 3 items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a rating scale from 0 to 10. It also has 1 item assessing days lost from school or work and 1 item assessing days of underproductivity. The scores for the first 3 items are summed to create a total score of 0 to 30, where higher score indicates greater impairment. Scores <=2 for each item and <= 6 for the total score are considered functional remission. (NCT04338321)
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32

,
InterventionUnits on scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32
Esketamine Nasal Spray + Oral Antidepressant (AD)-5.9-8.6-9.7-10.6-10.9-11.2-11.9-12.6
Quetiapine Extended Release (XR) + Oral AD-4.1-6.8-8.6-9.0-9.0-10.1-10.8-11.1

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Change From Baseline in Participant-reported Health Status as Assessed by EQ-5D-5L Score: VAS

Change from baseline in participant-reported health status as assessed by EQ-5D-5L Score: VAS was reported. The EQ-5D-5L is a standardized 2-part instrument for use as a measure of health outcome, primarily designed for self-completion by respondents. It essentially consists of the EQ-5D-5L descriptive system and the EQ-VAS. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicates improvement. (NCT04338321)
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32

,
InterventionUnits on Scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32
Esketamine Nasal Spray + Oral Antidepressant (AD)13.318.920.921.922.323.625.224.9
Quetiapine Extended Release (XR) + Oral AD9.716.117.220.219.621.823.224.5

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Change From Baseline in Participant-reported Work Productivity as Assessed by Work Productivity and Activity Impairment (WPAI): Depression Questionnaire

Change from baseline in participant-reported work productivity as assessed by WPAI: depression questionnaire was reported. The WPAI-D questionnaire is a validated short instrument that assesses impairment in work and other regular activities over the past 7 days. The WPAI yields four types of scores: (a) Absenteeism (work time missed); (b) Presenteeism (impairment at work / reduced on-the-job effectiveness); (c) Work productivity loss (overall work impairment / absenteeism plus presenteeism); (d) Activity Impairment. The first three scores were derived only for respondents who were working (should be missing for non-working), but the last score was applicable for all respondents. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity. (NCT04338321)
Timeframe: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32

,
InterventionUnits on scale (Mean)
Absenteeism Week 4Absenteeism Week 8Absenteeism Week 12Absenteeism Week 16Absenteeism Week 20Absenteeism Week 24Absenteeism Week 28Absenteeism Week 32Presenteeism Week 4Presenteeism Week 8Presenteeism Week 12Presenteeism Week 16Presenteeism Week 20Presenteeism Week 24Presenteeism Week 28Presenteeism Week 32Work productivity loss Week 4Work productivity loss Week 8Work productivity loss Week 12Work productivity loss Week 16Work productivity loss Week 20Work productivity loss Week 24Work productivity loss Week 28Work productivity loss Week 32Activity Impairment Week 4Activity Impairment Week 8Activity Impairment Week 12Activity Impairment Week 16Activity Impairment Week 20Activity Impairment Week 24Activity Impairment Week 28Activity Impairment Week 32
Esketamine Nasal Spray + Oral Antidepressant (AD)-11.95-19.02-21.87-22.85-27.88-26.83-27.16-28.90-21.75-31.70-35.46-36.96-39.80-42.83-43.00-47.58-20.94-32.91-36.68-38.13-41.11-45.31-44.40-50.20-20.29-30.31-33.96-35.07-33.88-36.69-40.00-41.92
Quetiapine Extended Release (XR) + Oral AD-8.37-13.62-17.25-14.24-18.70-21.03-17.90-16.68-9.13-16.86-23.22-24.50-26.34-31.60-33.29-33.88-9.46-18.21-25.62-24.50-26.57-30.63-32.61-35.48-13.43-24.25-28.28-30.95-30.93-36.84-37.62-39.59

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Change From Baseline in Participant-reported Health Status as Assessed by EQ-5D-5L Score: VAS at LOCF

Change from baseline in participant-reported health status as assessed by EQ-5D-5L score: VAS at LOCF was reported. The EQ-5D-5L is a standardized 2-part instrument for use as a measure of health outcome, primarily designed for self-completion by respondents. It essentially consists of the EQ-5D-5L descriptive system and the EQ-VAS. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicates improvement. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward. (NCT04338321)
Timeframe: Baseline, LOCF at Weeks 4, 8, 12, 16, 20, 24, 28, 32

,
InterventionUnits on Scale (Mean)
Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32
Esketamine Nasal Spray + Oral Antidepressant (AD)13.318.219.420.220.421.321.922.3
Quetiapine Extended Release (XR) + Oral AD9.714.014.416.115.416.917.318.0

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Percentage of Participants With Remission as Assessed by the Montgomery-Asberg Depression Rating Scale (MADRS) Score at Week 8

Percentage of participants with remission as assessed by the MADRS at Week 8 was reported. The MADRS is a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items, each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of the symptoms), for a total possible score of 60. Higher scores represent a more severe condition. The MADRS evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts. A participant was defined as being in remission if the MADRS total score was less than or equal to (<=)10 and no treatment or study discontinuation before Week 8. (NCT04338321)
Timeframe: Week 8

InterventionPercentage of participants (Number)
Esketamine Nasal Spray + Oral Antidepressant (AD)27.1
Quetiapine Extended Release (XR) + Oral AD17.6

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Percentage of Participants With Both Remission at Week 8 and Relapse-free Until Week 32

Percentage of participants with both remission at Week 8 and relapse-free until Week 32 were reported. A participant was defined as being in remission if the MADRS total score was <= 10 and no treatment or study discontinuation before Week 8. A relapse was defined by any of following: a) Worsening of depressive symptoms as indicated by MADRS total score greater than or equal to (>=) 22 confirmed by 1 additional assessment of MADRS total score >= 22 within the next 5 to 15 days. The date of the second MADRS assessment was used for the date of relapse; b) Any psychiatric hospitalization for: worsening of depression, suicide prevention or suicide attempt, the start date of hospitalization was the date of relapse; c) Suicide attempt, completed suicide, or any other clinically relevant event determined by investigator's judgment to be indicative of a relapse of depressive illness, but without hospitalized. The onset of the event was used for the date of relapse. (NCT04338321)
Timeframe: Week 32

InterventionPercentage of Participants (Number)
Esketamine Nasal Spray + Oral Antidepressant (AD)21.7
Quetiapine Extended Release (XR) + Oral AD14.1

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Change From Baseline in Clinician-rated Overall Severity of Depressive Illness as Assessed by CGI-S Scale Score at LOCF

Change from Baseline in clinician-rated overall severity of depressive illness as assessed by CGI-S scale score at LOCF was reported. The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 1 to 7. A participant is assessed on severity of mental illness at the time of rating according to: 1 = normal (not at all ill); 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants. LOCF is defined as the participants who had a missing value or who stopped treatment at a specific time point had their last non-missing value carried forward. (NCT04338321)
Timeframe: Baseline, LOCF at Weeks 2, 3, 4, 8, 12, 16, 20, 24, 28, 32

,
InterventionUnits on scale (Mean)
Week 2Week 3Week 4Week 8Week 12Week 16Week 20Week 24Week 28Week 32
Esketamine Nasal Spray + Oral Antidepressant (AD)-0.7-1.0-1.3-1.6-1.8-1.9-2.0-2.1-2.1-2.2
Quetiapine Extended Release (XR) + Oral AD-0.5-0.7-0.9-1.2-1.3-1.4-1.5-1.5-1.6-1.6

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Number of Participants With Treatment-emergent Adverse Events (TEAEs)

An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study. TEAEs were those events if they started after administration of the first dose until 14 days after the last dose of study medication for other TEAEs except serious; and first dose until 30 days after the last dose of study medication for serious TEAEs. (NCT04338321)
Timeframe: Up to Week 35

InterventionParticipants (Count of Participants)
Esketamine Nasal Spray + Oral Antidepressant (AD)307
Quetiapine Extended Release (XR) + Oral AD262

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Number of Participants With Suicidal Ideation or Behavior as Assessed by Columbia-Suicide Severity Rating Scale (C-SSRS) Score

Number of participants with suicidal ideation or behavior as assessed by C-SSRS score was reported. The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Suicidal ideation consists of 5 items: wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods (not plan) without intention to act, active suicidal ideation with some intent to act without specific plan, and active suicidal ideation with specific plan and intent. Suicidal behavior consists of 5 items: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt (non-fatal), and completed suicide. The maximum score (from the 10 categories) assigned for each participant was summarized into one of three broad categories: No suicidal ideation or behavior (0), Suicidal ideation (1 - 5), Suicidal behavior (6 - 10). Total score ranges from 1 to 10. Higher scores indicate more severe suicidal ideation and behavior. (NCT04338321)
Timeframe: Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32

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InterventionParticipants (Count of Participants)
Suicidal Ideation Week 1Suicidal Behavior Week 1Suicidal Ideation Week 2Suicidal Behavior Week 2Suicidal Ideation Week 3Suicidal Behavior Week 3Suicidal Ideation Week 4Suicidal Behavior Week 4Suicidal Ideation Week 8Suicidal Behavior Week 8Suicidal Ideation Week 12Suicidal Behavior Week 12Suicidal Ideation Week 16Suicidal Behavior Week 16Suicidal Ideation Week 20Suicidal Behavior Week 20Suicidal Ideation Week 24Suicidal Behavior Week 24Suicidal Ideation Week 28Suicidal Behavior Week 28Suicidal Ideation Week 32Suicidal Behavior Week 32
Esketamine Nasal Spray + Oral Antidepressant (AD)2202101902202101301211501408070
Quetiapine Extended Release (XR) + Oral AD250321170270180140121140905041

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