Trial | Phase | Enrollment | Study Type | Start Date | Status |
Neurocognitive Effectiveness in Treatment of First-episode Non-affective Psychosis: a Randomized Comparison of Aripiprazole, Quetiapine and Ziprasidone Over 1 Year [NCT02534363] | Phase 4 | 136 participants (Actual) | Interventional | 2005-10-31 | Completed |
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 4 | 300 participants (Anticipated) | Interventional | 2010-05-31 | Active, not recruiting |
[NCT01587066] | Phase 4 | 0 participants (Actual) | Interventional | 2010-08-31 | Withdrawn |
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 4 | 203 participants (Actual) | Interventional | 2008-10-31 | Completed |
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From an Inpatient Psychiatric H [NCT01193166] | Phase 4 | 0 participants (Actual) | Interventional | 2010-08-31 | Withdrawn(stopped due to This study was stopped due to an internal reconsideration of priorities of the product portfolio.)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 3 | 28 participants (Actual) | Interventional | 2010-09-30 | Completed |
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 2 | 11 participants (Actual) | Interventional | 2019-10-23 | Terminated(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 4 | 44 participants (Actual) | Interventional | 2018-05-21 | Completed |
Functional Reciprocity Between Heightened Stress Reactivity and Emotional Numbing in PTSD: Novel Predictors of Pharmacotherapeutic Outcomes [NCT01066156] | | 34 participants (Actual) | Interventional | 2010-02-28 | Completed |
Phase IV Study of Effects of 'Seroquel-XR' on the Improvement of Neurocognitive Function in People At-risk Mental States(ARMS) [NCT01250847] | Phase 4 | 83 participants (Anticipated) | Interventional | 2010-11-30 | Recruiting |
Chinese Longitudinal and Systematic Study of Bioplar Disorder [NCT05480150] | | 10,000 participants (Anticipated) | Interventional | 2021-11-01 | Recruiting |
Controlled, Double-blind, Randomized Clinical Trial for Prophylaxis of Postoperative Delirium in High Risk Surgical Patients With Quetiapine [NCT03739476] | Phase 3 | 50 participants (Actual) | Interventional | 2019-02-13 | Terminated(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) | Observational | 2013-04-01 | Completed |
Open-Label Study of Quetiapine for Mania In Preschool Children 4 to 6 Years of Age With Bipolar and Bipolar Spectrum Disorder [NCT00181883] | Phase 4 | 30 participants (Actual) | Interventional | 2005-02-28 | Completed |
The Effect of Quetiapine XR in Depressive Patients Showing Aberrant N100 Amplitude Slope [NCT01357967] | Phase 4 | 60 participants (Anticipated) | Interventional | 2011-05-31 | Recruiting |
Effectiveness of Antipsychotic Drugs to Treat Psychosis Syndrome: an Open Label, Controlled Study [NCT02137616] | | 300 participants (Anticipated) | Interventional | 2012-06-30 | Recruiting |
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 1 | 58 participants (Actual) | Interventional | 2019-03-27 | Completed |
Effects of Seroquel XR (Quetiapine Fumarate Extended-Release) on Sleep Architecture in Patients With Major Depressive Disorder [NCT01189318] | Phase 2 | 0 participants (Actual) | Interventional | 2012-03-31 | Withdrawn |
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 3 | 338 participants (Actual) | Interventional | 2006-09-30 | Completed |
Effects of Quetiapine on Sleep and Next Day Alertness in People With Obstructive Sleep Apnea [NCT05303935] | Phase 2 | 15 participants (Actual) | Interventional | 2022-05-25 | Completed |
Changes of Heart Rate Variability in Schizophrenic and Bipolar Patients Under the Medication of Aripiprazole and Quetiapine [NCT01047215] | Phase 4 | 120 participants (Anticipated) | Interventional | 2009-08-31 | Recruiting |
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 3 | 60 participants (Actual) | Interventional | 2017-01-23 | Completed |
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 4 | 200 participants (Anticipated) | Interventional | 2014-12-31 | Recruiting |
Neuroendocrine, Metabolite Substrates, Clinical Symptoms and Cognitive Function in Schizophrenia [NCT02423096] | | 200 participants (Anticipated) | Observational [Patient Registry] | 2013-12-31 | Recruiting |
[NCT02297763] | Phase 3 | 194 participants (Anticipated) | Interventional | 2015-03-31 | Not 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 2 | 105 participants (Actual) | Interventional | 2008-12-31 | Terminated(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) | Interventional | 2010-02-28 | Terminated(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 4 | 57 participants (Actual) | Interventional | 2008-12-31 | Completed |
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 3 | 1,210 participants (Anticipated) | Interventional | 2010-06-30 | Terminated(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 2 | 14 participants (Actual) | Interventional | 2014-12-31 | Completed |
A Single Dose Pharmacokinetic Study of Topical and Rectal Quetiapine Compared to Oral Quetiapine in Healthy Adults [NCT02131545] | Phase 1 | 10 participants (Actual) | Interventional | 2014-06-30 | Completed |
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 4 | 21 participants (Actual) | Interventional | 2015-02-01 | Completed |
Combination of Paroxetine CR and Quetiapine for the Treatment of Refractory Generalized Anxiety Disorder [NCT00113295] | Phase 4 | 50 participants (Actual) | Interventional | 2004-02-29 | Completed |
Risk and Protective Factors for SGA-induced Metabolic Syndrome in Bipolar Youth [NCT01858948] | Phase 3 | 19 participants (Actual) | Interventional | 2013-07-31 | Completed |
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 3 | 264 participants (Actual) | Interventional | 2008-03-31 | Completed |
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 3 | 676 participants (Actual) | Interventional | 2020-08-21 | Completed |
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 4 | 40 participants (Anticipated) | Interventional | 2006-03-31 | Completed |
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 3 | 250 participants (Anticipated) | Interventional | 2010-10-31 | Terminated(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 3 | 337 participants (Actual) | Interventional | 2015-07-08 | Completed |
Quetiapine in Melancholic Depression: an fMRI Study of Treatment-induced Changes in the Neurocircuitry of the Stress Response [NCT01200901] | Phase 4 | 20 participants (Actual) | Interventional | 2008-09-30 | Completed |
Exploring Alterations of Central Autonomic Modulation in Patients With Bipolar Depression [NCT01213121] | Phase 4 | 60 participants (Anticipated) | Interventional | 2010-09-30 | Recruiting |
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 4 | 149 participants (Actual) | Interventional | 2010-02-28 | Completed |
Continuation Electroconvulsive Therapy Associated With Pharmacotherapy Versus Pharmacotherapy Alone for Relapse Prevention in Major Depression. A Clinical, Controlled, Prospective and Randomized Trial [NCT01305707] | Phase 4 | 104 participants (Actual) | Interventional | 2009-07-31 | Terminated(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 4 | 24 participants (Actual) | Interventional | 2017-03-13 | Completed |
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 2 | 166 participants (Actual) | Interventional | 2008-01-31 | Terminated(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 4 | 96 participants (Actual) | Interventional | 2008-11-30 | Completed |
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 4 | 35 participants (Actual) | Interventional | 2009-09-30 | Completed |
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 3 | 29 participants (Actual) | Interventional | 2008-09-30 | Terminated(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) | Observational | 2022-11-28 | Recruiting |
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 4 | 120 participants (Anticipated) | Interventional | 2008-12-31 | Recruiting |
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 3 | 193 participants (Actual) | Interventional | 2009-01-31 | Completed |
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 3 | 100 participants (Anticipated) | Interventional | 2009-03-31 | Recruiting |
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) | Interventional | 2012-06-30 | Completed |
Quetiapine Augmentation of Prolonged Exposure (PE) Therapy for the Treatment of Co-occurring PTSD and Mild Traumatic Brain Injury [NCT04280965] | Early Phase 1 | 28 participants (Actual) | Interventional | 2019-02-01 | Completed |
Prospective, Double-Blind, Randomized Controlled Trial of Quetiapine as a Treatment for Delirium in Critically Ill Children [NCT03572257] | Phase 2/Phase 3 | 0 participants (Actual) | Interventional | 2019-04-15 | Withdrawn(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 1 | 74 participants (Actual) | Interventional | 2013-01-31 | Completed |
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 1 | 305 participants (Actual) | Interventional | 2014-02-28 | Completed |
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 1 | 60 participants (Anticipated) | Interventional | 2022-11-15 | Recruiting |
A Double-Blind, Placebo-Controlled Trial of Seroquel for the Treatment of Dysphoric Hypomania in Bipolar II Patients [NCT00186043] | Phase 4 | 55 participants (Actual) | Interventional | 2008-08-31 | Completed |
Double-blind Placebo-controlled Trial of Quetiapine in Anorexia Nervosa [NCT00518973] | | 21 participants (Actual) | Interventional | 2006-07-31 | Completed |
Interventions to Test the Alpha7 Nicotinic Receptor Model in Schizophrenia [NCT00509067] | Phase 2 | 43 participants (Actual) | Interventional | 2007-11-30 | Completed |
Impact of Quetiapine Prolong and Escitalopram on the Hypothalamic-pituitary-adrenocortical (HPA)-Axis Activity in Depressed Patients [NCT00953108] | Phase 3 | 60 participants (Actual) | Interventional | 2009-09-30 | Completed |
A Randomized Controlled Trial to Evaluate the Effectiveness of Clozapine Versus Olanzapine, Quetiapine or Risperidone in Treatment Resistant Bipolar Disorder [NCT02562287] | Phase 4 | 54 participants (Anticipated) | Interventional | 2015-10-31 | Recruiting |
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 4 | 7 participants (Actual) | Interventional | 2008-07-31 | Terminated(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 3 | 40 participants (Anticipated) | Interventional | 2008-10-31 | Completed |
Quetiapine Related Neurochemical Changes as Measured by Magnetic Resonance Spectroscopy in Patients With Schizophrenia [NCT00797927] | Phase 4 | 30 participants (Actual) | Interventional | 2007-01-31 | Completed |
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 3 | 331 participants (Actual) | Interventional | 2008-03-31 | Completed |
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 4 | 1,098 participants (Actual) | Interventional | 2003-09-30 | Completed |
Multimodal Neuroimaging of Treatment Effects in Adolescent Mania [NCT00893581] | | 169 participants (Actual) | Interventional | 2009-03-31 | Completed |
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 4 | 139 participants (Actual) | Interventional | 2009-06-30 | Completed |
Comparative Efficacy of Antidepressant Augmentation With Amantadine vs Pramipexole vs Quetiapine in Treatment-resistant Unipolar Depression: A Randomized Controlled Trial. [NCT04936126] | Phase 4 | 150 participants (Anticipated) | Interventional | 2021-08-07 | Recruiting |
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 3 | 798 participants (Actual) | Interventional | 2008-01-31 | Completed |
Effectiveness of Antipsychotic Combination With Psychosocial Intervention on Outcome of Patients With Schizophrenia:One-Year Follow up. [NCT00654576] | Phase 4 | 1,400 participants (Anticipated) | Interventional | 2005-02-28 | Completed |
Determining the Efficacy and Tolerance of Quetiapine Extended Release (XR) for the Management of Psychotic Aggression or Agitation in Adult Acute Psychiatry [NCT00986167] | Phase 4 | 72 participants (Anticipated) | Interventional | 2009-10-31 | Not 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 4 | 26 participants (Actual) | Interventional | 2009-05-31 | Completed |
A Randomized Open-label Active-controlled Study to Evaluate the Efficacy and Safety of Utapine Versus Seroquel in Patients With Bipolar Mania [NCT01043679] | Phase 4 | 40 participants (Anticipated) | Interventional | 2009-07-31 | Recruiting |
The Efficacy and Safety of Once-daily Quetiapine Extended Release in Patients With Schizophrenia Switched From Other Antipsychotics [NCT02142556] | Phase 3 | 61 participants (Actual) | Interventional | 2008-11-30 | Completed |
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 3 | 409 participants (Actual) | Interventional | 2007-08-31 | Completed |
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 2 | 233 participants (Actual) | Interventional | 2018-07-13 | Completed |
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 3 | 333 participants (Actual) | Interventional | 2002-09-30 | Completed |
Quetiapine in the Treatment of Psychotic Depression - a Pilot Study [NCT00751504] | Phase 3 | 16 participants (Actual) | Interventional | 2008-09-30 | Completed |
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 3 | 421 participants (Actual) | Interventional | 2009-04-30 | Completed |
[NCT00486798] | Phase 3 | 0 participants | Interventional | 2007-05-31 | Terminated(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 3 | 688 participants (Actual) | Interventional | 2008-11-30 | Completed |
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 3 | 240 participants (Actual) | Interventional | 2008-12-31 | Completed |
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 4 | 376 participants (Actual) | Interventional | 2008-04-30 | Completed |
Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients [NCT02612948] | Phase 4 | 82 participants (Actual) | Interventional | 2013-11-30 | Completed |
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 4 | 131 participants (Actual) | Interventional | 2010-12-31 | Terminated(stopped due to Difficulty of recruitment.) |
Effect of Quetiapine on Marijuana Withdrawal and Relapse [NCT00743366] | Phase 2 | 20 participants (Actual) | Interventional | 2008-08-31 | Completed |
Atypical Antipsychotics and Hyperglycemic Emergencies: Multicentre, Retrospective Cohort Study of Administrative Data [NCT02582736] | | 725,489 participants (Actual) | Observational | 2012-04-30 | Completed |
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 4 | 120 participants (Actual) | Interventional | 2008-12-31 | Completed |
Quetiapine XR in the Treatment of Comorbid Generalized Anxiety Disorder in Bipolar Depression With or Without Substance Use Disorder [NCT00671853] | Phase 3 | 120 participants (Actual) | Interventional | 2008-04-30 | Completed |
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 1 | 54 participants (Actual) | Interventional | 2010-06-30 | Completed |
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 4 | 32 participants (Actual) | Interventional | 2010-06-30 | Terminated(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 3 | 255 participants (Anticipated) | Interventional | 2023-09-18 | Recruiting |
Anxiolytic Effects of Single-dose Quetiapine XR Administration on Clinical Symptoms and Amygdala Activation During Exposure in Patients With Simple Phobia [NCT00872716] | Phase 2 | 60 participants (Actual) | Interventional | 2009-04-30 | Completed |
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 2 | 0 participants | Interventional | 2006-03-31 | Completed |
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 3 | 227 participants (Actual) | Interventional | 2008-03-31 | Terminated(stopped due to Interim analysis showed inadequate efficacy of bifeprunox) |
Cardiovascular Biomarkers During Quetiapine Treatment of Depression [NCT00951483] | Phase 4 | 91 participants (Actual) | Interventional | 2009-07-31 | Completed |
Study of Evaluating Quetiapine in Improving Sleep Quality of Schizophrenia [NCT00642369] | | 60 participants (Actual) | Interventional | 2008-03-31 | Completed |
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) | Interventional | 2008-03-31 | Recruiting |
Quetiapine Augmentation for Primary Anxiety Disorder or Mood Disorders With Comorbid Anxiety Symptoms [NCT00912535] | Phase 4 | 39 participants (Actual) | Interventional | 2009-05-31 | Completed |
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 1 | 10 participants (Anticipated) | Interventional | 2009-01-31 | Completed |
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 3 | 346 participants (Actual) | Interventional | 2008-06-30 | Terminated(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 1 | 55 participants (Actual) | Interventional | 2020-06-15 | Completed |
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 1 | 119 participants (Actual) | Interventional | 2016-09-30 | Completed |
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 4 | 21 participants (Actual) | Interventional | 2006-01-31 | Completed |
Examination of the Pharmacokinetic Properties of Three Generic Medications and Their Respective Brand Preparations in Healthy Male Volunteers [NCT01400165] | Phase 1 | 30 participants (Anticipated) | Interventional | 2011-07-31 | Recruiting |
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 4 | 90 participants (Actual) | Interventional | 2008-11-30 | Completed |
An 8-week, Randomized, Double-Blind, Placebo-Controlled Trial of Seroquel SR Co-administration for SSRI-Resistant, Comorbid Panic Disorder [NCT00619892] | Phase 4 | 26 participants (Actual) | Interventional | 2008-02-29 | Completed |
[NCT00919607] | Phase 1 | 31 participants (Actual) | Interventional | 2009-06-30 | Completed |
A Randomized, Double-Blind, Placebo Controlled Exploratory Study of Augmentation of Seroquel XR With Pramipexole Dihydrochloride for Bipolar Depression [NCT00893841] | Phase 2 | 96 participants (Actual) | Interventional | 2009-02-28 | Completed |
Quetiapine (Seroquel XR) for the Treatment of Fibromyalgia: a Clinical and Mechanistic Pilot Study [NCT00983320] | Phase 4 | 52 participants (Actual) | Interventional | 2008-04-30 | Completed |
Use, Effects and Side-effects of Second-generation Antipsychotics in a Naturalistic Setting. [NCT00932529] | Phase 4 | 226 participants (Actual) | Interventional | 2003-02-28 | Completed |
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 1 | 63 participants (Actual) | Interventional | 2008-07-31 | Completed |
The Effect of the Atypical Antipsychotic Quetiapine in the Treatment of Postpartum Depressive Disorder With Psychotic Symptoms [NCT00681668] | Phase 2 | 5 participants (Actual) | Interventional | 2007-08-31 | Terminated(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 3 | 21 participants (Actual) | Interventional | 2008-10-31 | Completed |
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) | Observational | 2015-07-24 | Completed |
Phase I Study of FK949E - Multiple Dose Study of Elderly Adult Patients With Major Depressive Disorder [NCT01903200] | Phase 1 | 16 participants (Actual) | Interventional | 2010-02-28 | Completed |
[NCT00838032] | Phase 4 | 70 participants (Anticipated) | Interventional | 2008-08-31 | Recruiting |
Compare Efficacy and Safety Between Quetiapine and Haloperidol in Treatment Delirium [NCT00954603] | Phase 3 | 52 participants (Actual) | Interventional | 2009-06-30 | Terminated(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 4 | 100 participants (Anticipated) | Interventional | 2014-02-28 | Not yet recruiting |
The Effects of Quetiapine XR on Cognition, Mood and Anxiety Symptoms in SSRI-Resistant Unipolar Depression [NCT00517387] | Phase 3 | 64 participants (Anticipated) | Interventional | 2007-09-30 | Completed |
Treatment of Major Depressive Disorder With Psychotic Features With Quetiapine Monotherapy; Quetiapine and Citalopram; or Haloperidol and Citalopram [NCT00174603] | Phase 3 | 60 participants | Interventional | 2005-08-31 | Terminated(stopped due to Unable to recruit subjects) |
Bariatric Surgery and Pharmacokinetics Quetiapine: BAR-MEDS Quetiapine [NCT03449472] | | 12 participants (Anticipated) | Observational | 2018-01-02 | Recruiting |
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 4 | 20 participants (Actual) | Interventional | 2006-12-31 | Completed |
[NCT00182013] | Phase 4 | 106 participants (Actual) | Interventional | 2001-06-30 | Completed |
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 4 | 80 participants | Interventional | 2003-10-31 | Completed |
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 3 | 381 participants (Actual) | Interventional | 2004-08-31 | Completed |
The Effects of Quetiapine on Sleep During Alcohol Abstinence [NCT00434876] | Phase 3 | 22 participants (Actual) | Interventional | 2007-08-31 | Completed |
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 3 | 450 participants (Actual) | Interventional | 2006-09-30 | Completed |
Effects of Quetiapine XR in Schizophrenic Patients With Cannabis Abuse and/or Cannabis Induced Psychosis -Pilot Study- [NCT01071135] | Phase 3 | 5 participants (Actual) | Interventional | 2009-09-30 | Terminated(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 4 | 125 participants (Actual) | Interventional | 2007-11-30 | Terminated(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 3 | 535 participants | Interventional | 2004-11-30 | Completed |
A Placebo-controlled Trial of Adjunctive Quetiapine for Refractory PTSD [NCT00292370] | Phase 4 | 124 participants (Actual) | Interventional | 2006-01-31 | Completed |
A Comparative Study of New Medications for Psychosis in Adolescents [NCT00222495] | | 30 participants | Interventional | 2002-08-31 | Completed |
[NCT00060489] | Phase 3 | 0 participants | Interventional | 2002-09-30 | Completed |
Comparative Efficacy and Acceptability of Lithium, Valproate, Oxcarbazepine, Quetiapine, Olanzapine, and Ziprasidone in Bipolar I Disorder, Manic or Mixed Phase [NCT01893229] | Phase 4 | 120 participants (Anticipated) | Interventional | 2013-09-30 | Recruiting |
Phase I Study of FK949E - A Study of Drug-drug Interactions Between FK949E and Fluvoxamine in Healthy Male Adults [NCT01908296] | Phase 1 | 24 participants (Actual) | Interventional | 2011-07-31 | Completed |
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 1 | 16 participants (Actual) | Interventional | 2012-03-26 | Completed |
An Exploratory Analysis of Immune and Inflammatory Response Associated With Clozapine Versus Non-Clozapine Antipsychotics in Individuals With Treatment-resistant Schizophrenia [NCT05741502] | Phase 4 | 60 participants (Anticipated) | Interventional | 2023-08-16 | Recruiting |
Algorithm Guided Treatment Strategies for Bipolar Depression [NCT01938859] | Phase 4 | 360 participants (Anticipated) | Interventional | 2012-06-30 | Active, 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 3 | 197 participants (Actual) | Interventional | 2005-03-31 | Completed |
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 3 | 672 participants | Interventional | 2005-08-31 | Completed |
A Randomized, Placebo-Controlled Trial of Quetiapine (Seroquel) Monotherapy in the Treatment of PTSD [NCT00237393] | Phase 4 | 80 participants (Actual) | Interventional | 2003-08-31 | Completed |
A Single-Blind Prospective Study of Quetiapine for the Treatment of Mood Disorders in Adolescents [NCT00221468] | Phase 3 | 20 participants (Actual) | Interventional | 2003-06-30 | Completed |
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 1 | 31 participants (Actual) | Interventional | 2022-06-13 | Completed |
Comparison of Venlafaxine Augmentation With Quetiapine v.s. Placebo in Treatment Resistant Depression [NCT00253266] | Phase 4 | 126 participants (Actual) | Interventional | 2008-04-30 | Completed |
Safety and Efficacy of Seroquel in First Episode Schizophrenia [NCT00254241] | Phase 4 | 80 participants | Interventional | 2002-05-31 | Completed |
The Effect of Quetiapine on Psychotic-Like Symptoms in Borderline Personality Disordered Patients: A Randomised Placebo-Controlled Trial [NCT00254748] | Phase 2 | 40 participants (Anticipated) | Interventional | 2004-06-30 | Completed |
An Open Label, Double-blind Discontinuation Study of Quetiapine (Extended Release) XR in Social Anxiety Disorder [NCT00606541] | Early Phase 1 | 55 participants (Actual) | Interventional | 2008-01-31 | Terminated(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 2 | 90 participants (Actual) | Interventional | 2023-03-01 | Completed |
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 2 | 389 participants (Actual) | Interventional | 2020-11-20 | Active, not recruiting |
Quetiapine vs. Placebo in Alcohol Relapse Prevention - a Pilot Study [NCT00561587] | Phase 2 | 40 participants (Anticipated) | Interventional | 2007-11-30 | Completed |
Methamphetamine-Quetiapine Interaction in Humans: A Pilot Study [NCT00567866] | Early Phase 1 | 10 participants (Actual) | Interventional | 2008-01-31 | Terminated(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 2 | 24 participants (Actual) | Interventional | 2007-02-28 | Terminated(stopped due to Lack of Enrollment) |
Acute Psychotherapy for Bipolar II Depression [NCT01133821] | Phase 4 | 92 participants (Actual) | Interventional | 2010-08-31 | Completed |
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 3 | 50 participants (Actual) | Interventional | 2003-11-30 | Completed |
A Randomized, Double-Blind, Placebo Controlled Study Of Quetiapine SR (QTP) As Adjunctive Treatment In Mixed States (MS) Of Bipolar Disorder [NCT01195363] | Phase 4 | 28 participants (Actual) | Interventional | 2007-04-30 | Completed |
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 1 | 54 participants (Actual) | Interventional | 2011-04-30 | Completed |
Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies [NCT02893371] | | 1,037,352 participants (Actual) | Observational | 2016-09-30 | Completed |
Comparison of Single-Dose Plasma and Blood Concentrations of Aripiprazole, Olanzapine, Quetiapine, Paliperidone and Risperidone After Capillary and Venous Blood Sample Collection [NCT01607762] | Phase 1 | 31 participants (Actual) | Interventional | 2012-02-29 | Completed |
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 3 | 216 participants (Actual) | Interventional | 2008-02-29 | Completed |
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 4 | 40 participants (Actual) | Interventional | 2007-06-30 | Completed |
Randomized, Placebo-Controlled Effectiveness Study of Quetiapine XR in Co-Morbid Depressive and Anxiety Disorders [NCT00688818] | | 108 participants (Actual) | Interventional | 2008-06-30 | Completed |
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 4 | 88 participants (Actual) | Interventional | 2008-05-31 | Completed |
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 3 | 388 participants (Actual) | Interventional | 2009-04-30 | Completed |
Effects of Seroquel on Sleep Architecture in Patients With Bipolar Depression or Major Depressive Disorder - An Open Label Study [NCT00616889] | | 15 participants (Actual) | Observational | 2006-05-31 | Completed |
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 4 | 120 participants (Anticipated) | Interventional | 2007-04-30 | Completed |
The Interest of a Specific Combined Treatment (Psychotherapy and Pharmacotherapy) in Patients With Dissociative Disorders [NCT00630981] | | 30 participants (Actual) | Observational | 2008-02-29 | Active, 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 4 | 450 participants (Actual) | Interventional | 2010-05-31 | Completed |
A Study of Individualized Diagnosis and Treatment for Major Depressive Disorder With Atypical Features [NCT04209166] | | 780 participants (Anticipated) | Interventional | 2019-08-12 | Recruiting |
The Role of miR-30 Family Dysregulation in Response to Antipsychotic Treatment [NCT02650102] | Phase 1/Phase 2 | 200 participants (Anticipated) | Interventional | 2013-01-31 | Recruiting |
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 4 | 32 participants (Actual) | Interventional | 2008-09-30 | Terminated(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 4 | 30 participants (Actual) | Interventional | 2008-03-31 | Completed |
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 3 | 876 participants (Anticipated) | Interventional | 2006-04-30 | Completed |
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 3 | 535 participants | Interventional | 2004-06-30 | Completed |
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 3 | 64 participants (Actual) | Interventional | 2009-04-30 | Terminated(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 3 | 27 participants (Actual) | Interventional | 2009-05-31 | Completed |
Seroquel on Glucose Metabolism [NCT00214578] | Phase 4 | 572 participants | Interventional | 2004-04-30 | Completed |
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 1 | 40 participants (Actual) | Interventional | 2012-11-30 | Completed |
Phase I Study of FK949E - Multiple Dose Study of Non-Elderly Adult Patients With Major Depressive Disorder (MDD) [NCT01871974] | Phase 1 | 16 participants (Actual) | Interventional | 2009-05-31 | Completed |
Pharmacokinetic Study of FK949E -A Pharmacokinetic Study in Healthy Male Volunteers to Investigate the Effect of Food on the Pharmacokinetics of FK949E [NCT01871987] | Phase 1 | 24 participants (Actual) | Interventional | 2009-06-30 | Completed |
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) | Observational | 2005-10-31 | Completed |
Melancholic Depression and Insomnia as Predictors of Response to Quetiapine in Patients With Major Depression [NCT03207438] | Phase 4 | 1,790 participants (Actual) | Interventional | 2006-04-30 | Completed |
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 3 | 400 participants | Interventional | 2006-12-31 | Completed |
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 3 | 150 participants | Interventional | 2005-08-31 | Completed |
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 3 | 234 participants (Anticipated) | Interventional | 2007-07-31 | Terminated(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 4 | 20 participants (Anticipated) | Interventional | 2006-02-28 | Completed |
[NCT00462618] | Phase 2/Phase 3 | 32 participants (Actual) | Interventional | 2007-04-30 | Completed |
Antipsychotic Polypharmacy in Schizophrenia [NCT00493233] | | 100 participants (Anticipated) | Interventional | 2006-11-30 | Completed |
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 3 | 757 participants (Actual) | Interventional | 2020-09-15 | Completed |
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 4 | 60 participants (Anticipated) | Interventional | 2007-08-31 | Completed |
Schizophrenia Sensory Gating Deficit With Quetiapine [NCT00536783] | | 20 participants (Anticipated) | Observational | 2004-04-30 | Completed |
Open-Label Pilot Study of Quetiapine Treatment for Cannabis Dependence [NCT00954681] | Phase 2 | 15 participants (Actual) | Interventional | 2009-08-31 | Completed |
Quetiapine and the Dopaminergic Epigenetic Control - a Pilot Study [NCT00370500] | Phase 4 | 100 participants (Actual) | Interventional | 2007-04-30 | Completed |
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 4 | 60 participants | Interventional | 2003-11-30 | Completed |
Differences in Cognitive Function Due to Acute Sedative Effects of Risperidone and Quetiapine in Stable Bipolar I Out-Patients. [NCT00097032] | Phase 3 | 30 participants (Actual) | Interventional | 2004-10-31 | Completed |
Efficacy of Quetiapine in the Reduction of Cocaine Use and Cravings in Individuals With Cocaine Dependence [NCT00232336] | Phase 4 | 42 participants (Actual) | Interventional | 2003-10-31 | Completed |
A Double-Blind Randomized Placebo Controlled Study of Quetiapine for the Treatment of Depression in Adolescents With Bipolar Disorder [NCT00232414] | Phase 3 | 30 participants (Anticipated) | Interventional | 2005-10-31 | Completed |
Quetiapine for the Treatment of Insomnia Associated With Alzheimer's Disease [NCT00232570] | | 18 participants (Anticipated) | Interventional | 2005-11-30 | Recruiting |
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 3 | 700 participants | Interventional | 2004-07-31 | Completed |
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 3 | 100 participants (Anticipated) | Interventional | 2004-06-30 | Completed |
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 3 | 3,000 participants | Interventional | 2005-12-31 | Completed |
Dopaminergic Modulation of Choroidal Blood Flow Changes During Dark/Light Transitions [NCT00280501] | | 21 participants (Actual) | Interventional | 2005-08-31 | Completed |
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 3 | 676 participants (Actual) | Interventional | 2005-05-31 | Completed |
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 3 | 710 participants | Interventional | 2004-03-31 | Completed |
Efficacy of Quetiapine in Generalised Social Anxiety Disorder, a Double-blind, Placebo-controlled Study [NCT00302770] | Phase 3 | 50 participants (Anticipated) | Interventional | 2006-06-30 | Terminated(stopped due to This study was terminated due to poor enrollment) |
Interaction Between IV Cocaine and Quetiapine [NCT00087750] | Phase 1 | 12 participants | Interventional | 2003-10-31 | Active, not recruiting |
Efficacy of Quetiapine Compared to Risperidone on Negative Symptoms and Cognition With Regard to Underlying Neurobiological Mechanisms and Brain Activation. [NCT00305422] | Phase 3 | 45 participants (Actual) | Interventional | 2001-11-30 | Completed |
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 4 | 340 participants | Interventional | 2004-07-31 | Completed |
Quetiapine Treatment for Symptoms Associated With Borderline Personality Disorder [NCT00122070] | Phase 3 | 15 participants (Actual) | Interventional | 2005-05-31 | Completed |
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 3 | 249 participants (Anticipated) | Interventional | 2004-09-30 | Completed |
Quetiapine for Primary Insomnia Patients : A Randomized Controlled Trial [NCT00328822] | | 16 participants (Anticipated) | Interventional | 2006-12-31 | Completed |
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 3 | 330 participants | Interventional | 2003-10-31 | Completed |
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 3 | 800 participants (Anticipated) | Interventional | 2006-04-30 | Completed |
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 3 | 530 participants | Interventional | 2004-06-30 | Completed |
A Double-Blind Study of Quetiapine Fumarate (Seroquel) for the Treatment of Type A vs.Type B Alcoholics. [NCT00124059] | Phase 3 | 61 participants (Actual) | Interventional | 2003-03-31 | Completed |
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 3 | 600 participants | Interventional | 2006-04-30 | Completed |
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 3 | 399 participants (Actual) | Interventional | 2006-04-30 | Completed |
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 3 | 220 participants (Actual) | Interventional | 2004-07-31 | Completed |
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 3 | 286 participants (Actual) | Interventional | 2006-12-31 | Completed |
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 4 | 120 participants (Anticipated) | Interventional | 2006-12-31 | Completed |
Phase IV Study to Investigate if Valproate Add-on Therapy is Superior to Quetiapine Monotherapy in Acutely Manic Patients [NCT00139074] | Phase 4 | 17 participants (Actual) | Interventional | 2005-07-31 | Terminated(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 3 | 450 participants (Anticipated) | Interventional | 2006-05-31 | Completed |
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 3 | 494 participants (Actual) | Interventional | 2006-05-31 | Completed |
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 3 | 350 participants | Interventional | 2006-01-31 | Completed |
Randomized, Open Label, 8-Week Study of Quetiapine and Risperidone on Quality of Life in Female With Schizophrenia [NCT00498004] | Phase 4 | 100 participants (Anticipated) | Interventional | 2007-08-31 | Terminated(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 4 | 54 participants (Actual) | Interventional | 2007-05-31 | Completed |
Quetiapine XR Monotherapy or Adjunctive Therapy to Antidepressants in the Treatment of Major Depressive Disorder With Comorbid Generalized Anxiety Disorder [NCT00868374] | Phase 3 | 23 participants (Actual) | Interventional | 2008-06-30 | Terminated(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 4 | 482 participants (Actual) | Interventional | 2010-09-30 | Completed |
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 3 | 290 participants | Interventional | 2001-11-30 | Completed |
[NCT00161018] | Phase 3 | 150 participants | Interventional | 2003-11-30 | Completed |
Seroquel (Quetiapine) Therapy for Schizophrenia and Schizoaffective Disorders and Comorbid Cocaine and/or Amphetamine Abuse/Dependence: A Comparative Study With Risperidone [NCT00208143] | Phase 4 | 20 participants | Interventional | 2003-11-30 | Completed |
Effectiveness of Atypical Vs Conventional Antipsychotics [NCT00237861] | Phase 4 | 0 participants | Interventional | | Completed |
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 2 | 30 participants | Interventional | 2005-06-30 | Completed |
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 4 | 356 participants (Actual) | Interventional | 2009-06-30 | Completed |
Functional and Neurochemical Brain Changes in First-episode Bipolar Mania Following Successful Treatment With Lithium or Quetiapine [NCT00609193] | | 81 participants (Actual) | Observational | 2008-01-31 | Completed |
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 4 | 75 participants (Actual) | Interventional | 2010-11-30 | Completed |
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 3 | 361 participants (Actual) | Interventional | 2010-12-31 | Completed |
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 3 | 150 participants | Interventional | 2003-07-31 | Completed |
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 4 | 418 participants (Anticipated) | Interventional | 2023-11-01 | Not 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) | Interventional | 2008-04-30 | Completed |
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) | Interventional | 2007-12-31 | Completed |
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 3 | 710 participants | Interventional | 2004-04-30 | Completed |
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 3 | 83 participants (Actual) | Interventional | 2007-04-30 | Terminated(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 4 | 1,600 participants | Interventional | 2000-12-31 | Completed |
Treatment of Agitation/Psychosis in Dementia/Parkinsonism (TAP/DAP) [NCT00043849] | Phase 4 | 60 participants | Interventional | 2002-07-31 | Completed |
Treatment and Outcome of Early Onset Bipolar Disorder [NCT00048802] | Phase 4 | 40 participants | Interventional | 2002-08-31 | Completed |
Comparative Effectiveness of Antipsychotic Medications in Patients With Alzheimer's Disease (CATIE Alzheimer's Disease Trial) [NCT00015548] | | 450 participants | Interventional | 2001-03-31 | Completed |
Predicting the Optimal Pharmacotherapy for Outpatients With Schizophrenia [NCT00018642] | | 0 participants | Interventional | 1997-04-30 | Completed |
[NCT00034905] | Phase 4 | 0 participants | Interventional | 2001-07-31 | Completed |
Psychopharmacologic Aspects of Motor Slowing in Schizophrenia [NCT00018668] | Phase 4 | 0 participants | Interventional | 2000-10-31 | Completed |
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 3 | 454 participants (Actual) | Interventional | 2004-11-30 | Completed |
5-HT2A-receptor Binding: Implications for the Pathophysiology of Schizophrenia and Effects of Treatment With Antipsychotic Drugs [NCT00207064] | | 46 participants (Actual) | Interventional | 2004-04-30 | Completed |
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 4 | 50 participants (Anticipated) | Interventional | 2003-09-30 | Completed |
A Randomized, Double-Blind, Placebo-Controlled Pilot Study of Quetiapine in Social Anxiety Disorder [NCT00215254] | Phase 2/Phase 3 | 15 participants | Interventional | 2004-03-31 | Completed |
A Randomized, Double-Blind, Placebo-Controlled Add-On Trial of Quetiapine in Patients With Bipolar Disorder and Cocaine Dependence [NCT00223210] | Phase 4 | 100 participants (Actual) | Interventional | 2005-11-30 | Completed |
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 4 | 225 participants (Actual) | Interventional | 2003-06-30 | Completed |
A Randomized, Double-Blind, Placebo-Controlled Add-On Trial of Quetiapine in Patients With Bipolar Disorder and Alcohol Abuse/ Dependence. [NCT00223249] | Phase 4 | 115 participants (Actual) | Interventional | 2002-11-30 | Completed |
Preventing Relapse: Oral Antipsychotics Compared To Injectables: Evaluating Efficacy (PROACTIVE) [NCT00330863] | Phase 4 | 357 participants (Actual) | Interventional | 2006-05-31 | Completed |
Psychotherapy for Bipolar II Depression, Pilot Study, Phase II [NCT00411463] | Phase 2/Phase 3 | 25 participants (Actual) | Interventional | 2006-12-31 | Completed |
CONSTATRE: Risperdal Consta Trial Of Relapse Prevention And Effectiveness [NCT00216476] | Phase 3 | 753 participants (Actual) | Interventional | 2004-10-31 | Completed |
Glucose and Lipid Metabolism on Antipsychotic Medication [NCT00515723] | | 96 participants (Actual) | Interventional | 2001-09-30 | Completed |
A Phase II Double-blind, Placebo-controlled Trial of Quetiapine for Frequent, Heavy Drinkers (Seroquel2) [NCT00674765] | Phase 2 | 156 participants (Actual) | Interventional | 2008-01-31 | Completed |
Open-label Multicentre Study on Efficacy and Safety of Oral Quetiapine (Seroquel XR) in Adults With Schizophrenia [NCT00852631] | Phase 3 | 28 participants (Actual) | Interventional | 2009-02-28 | Terminated(stopped due to The study was prematurely terminated due to insufficient recruitment.) |
Seroquel XR for the Management of Borderline Personality Disorder (BPD) [NCT00880919] | Phase 3 | 95 participants (Actual) | Interventional | 2008-06-30 | Completed |
Neuroleptic Induced Movement Disorders in Older Patients [NCT00255879] | Phase 1 | 250 participants | Interventional | 1999-01-31 | Completed |
A Randomized Control Trial Comparing Quetiapine to Risperidone in Bipolar Disorder Outpatients With Current Stimulant Dependence [NCT00227123] | | 96 participants (Actual) | Interventional | 2002-10-31 | Completed |
Quetiapine Decreases Smoking in Patients With Chronic Schizophrenia [NCT00231101] | | 40 participants | Interventional | 2004-01-31 | Recruiting |
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 3 | 550 participants | Interventional | 2004-11-30 | Completed |
Quetiapine Augmentation in Severe Obsessive Compulsive Disorder (OCD) - Pilot Study [NCT00254735] | Phase 3 | 44 participants (Actual) | Interventional | 2002-04-30 | Completed |
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 3 | 44 participants (Actual) | Interventional | 2002-01-31 | Completed |
Fast Titration Of Quetiapine Versus Currently Approved Titration: A Randomised, Multicentre, Parallel Group Open Trial In Schizophrenia And Schizoaffective Disorder [NCT00254813] | Phase 3 | 150 participants | Interventional | 2004-10-31 | Completed |
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 4 | 85 participants (Actual) | Interventional | 2005-09-30 | Completed |
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 1 | 54 participants (Actual) | Interventional | 2011-04-30 | Completed |
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 3 | 90 participants (Anticipated) | Interventional | 2004-12-31 | Completed |
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 3 | 1,255 participants (Actual) | Interventional | 2005-03-31 | Completed |
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 3 | 40 participants (Anticipated) | Interventional | 2004-02-29 | Completed |
Depakote ER vs. Seroquel for Agitated Behaviors in Nursing Home Care Unit Patients With Dementia [NCT00315900] | Phase 3 | 20 participants (Actual) | Interventional | 2006-05-01 | Terminated(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 3 | 493 participants (Actual) | Interventional | 2006-04-30 | Completed |
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 3 | 600 participants | Interventional | 2006-04-30 | Completed |
Fast Titration of Quetiapine Versus Conventional Titration in the Treatment of Schizophrenia/Schizoaffective Disorder: a Randomised, Parallel Group Open Trial [NCT00304473] | Phase 3 | 40 participants | Interventional | 2004-08-31 | Completed |
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 4 | 323 participants (Actual) | Interventional | 2006-07-31 | Completed |
The Impact of Quetiapine on the Drug Abuse Patterns of Addicted Schizophrenic Patients [NCT00295412] | Phase 4 | 0 participants | Interventional | | Completed |
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 3 | 60 participants (Actual) | Interventional | 2004-12-31 | Completed |
A Multi-center, Randomized, Open, Treatment-switching Study From Orally Administered Antipsychotic Monotherapy in the Treatment of Chronic Schizophrenic and Schizoaffective Patients [NCT00304616] | Phase 4 | 500 participants | Interventional | 2004-10-31 | Completed |
Duration of Maintenance Anti-psychotic Therapy After First -Episode Schizophrenia: a Double-blind Randomized Placebo-control Relapse Prevention Study [NCT00334035] | Phase 4 | 169 participants (Actual) | Interventional | 2003-08-31 | Completed |
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 3 | 575 participants | Interventional | 2006-03-31 | Completed |
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 1 | 0 participants | Interventional | | Completed |
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 1 | 0 participants | Interventional | | Completed |
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 1 | 0 participants | Interventional | | Completed |
[NCT03007303] | | 30 participants (Anticipated) | Observational [Patient Registry] | 2016-06-30 | Recruiting |
A Pilot Study on the Safety, Tolerability, and Effectiveness of Quetiapine in Postpartum Depression [NCT04950868] | Phase 1 | 30 participants (Anticipated) | Interventional | 2022-03-18 | Recruiting |
Quetiapine as a Prophylactic Agent for Early Postoperative Delirium in High Risk Patients in Open Heart Surgeries [NCT05801289] | | 60 participants (Anticipated) | Interventional | 2022-12-04 | Recruiting |
A Longitudinal Comparison of Aripiprazole vs. Higher Metabolic Risk Antipsychotic Drugs on Adiposity Using MRI [NCT01739127] | | 83 participants (Actual) | Observational | 2012-11-30 | Completed |
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 3 | 104 participants (Anticipated) | Interventional | 2012-11-30 | Recruiting |
Randomized Controlled Trial Comparing Haloperidol, Quetiapine and Placebo in the Pharmacological Treatment of Delirium : The Haloquet Trial [NCT01811459] | Phase 3 | 107 participants (Actual) | Interventional | 2013-02-28 | Completed |
Atypical Antipsychotics Influence on the Safety of the Heart and Monitoring Indicators Model Building [NCT04446234] | Phase 4 | 350 participants (Anticipated) | Interventional | 2021-05-31 | Not yet recruiting |
Correlation Between Cognitive Function and Relapse of Schizophrenia Regarding Dose Reduction in Patients Undergoing High-dose Antipsychotic Therapy [NCT03019887] | | 139 participants (Actual) | Interventional | 2011-04-30 | Completed |
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 3 | 2,182 participants (Actual) | Interventional | 2012-12-31 | Completed |
Phase 2 Study of FK949E - Double-blind, Placebo-controlled, Comparative Study in Major Depressive Disorder Patients With Inadequate Response to Existing Antidepressants [NCT01725282] | Phase 2 | 172 participants (Actual) | Interventional | 2011-12-14 | Completed |
Comparative Safety, Tolerability, and Effectiveness of Lithium Versus Quetiapine in Patients Across the Spectrum of Bipolar Disorder [NCT01526148] | Phase 4 | 42 participants (Actual) | Interventional | 2012-01-31 | Terminated(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 4 | 14 participants (Actual) | Interventional | 2008-01-31 | Terminated(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 3 | 475 participants (Actual) | Interventional | 2019-11-15 | Completed |
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 3 | 1,254 participants (Anticipated) | Interventional | 2023-08-01 | Not yet recruiting |
Brain Imaging of Quetiapine Response in Anxious Depression [NCT00982345] | Phase 4 | 20 participants (Actual) | Interventional | 2009-03-31 | Completed |
Phase I Study of FK949E - Phase I Oral Multiple-dose Study in Patients With Major Depressive Disorder [NCT01924520] | Phase 1 | 32 participants (Actual) | Interventional | 2010-11-30 | Completed |
Pharmacokinetics of Quetiapine Across Pregnancy and Postpartum [NCT02978534] | | 4 participants (Actual) | Observational | 2016-03-31 | Completed |
Phase IV Study of Quetiapine XR Aimed at Disability and Cognitive Impairments. [NCT00746421] | Phase 4 | 32 participants (Actual) | Interventional | 2010-01-31 | Terminated(stopped due to Sponsor withdrew funding) |
Trazodone vs. Quetiapine for the Treatment of ICU Delirium: A Prospective Observational Pilot Study [NCT05307003] | | 60 participants (Anticipated) | Observational | 2023-04-01 | Recruiting |
Effects of Sleep Disorders and Sedative-hypnotic Medications on Health-related Quality of Life in Chronic Kidney Disease Patients [NCT05240261] | Phase 1 | 60 participants (Anticipated) | Interventional | 2022-05-01 | Not 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 4 | 0 participants (Actual) | Interventional | 2023-03-28 | Withdrawn(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 4 | 23 participants (Actual) | Interventional | 2004-03-31 | Completed |
A Randomised Pragmatic Trial Comparing the Clinical and Cost Effectiveness of Lithium and Quetiapine Augmentation in Treatment Resistant Depression [NCT03004521] | Phase 4 | 276 participants (Anticipated) | Interventional | 2016-11-30 | Recruiting |
Comparison of Quetiapine and Trazodone Treatment for Insomnia in Dually Diagnosed Veterans: an Open (e.g. Unblinded) Randomized Stay-Switch Pilot Trial [NCT01662297] | Phase 4 | 1 participants (Actual) | Interventional | 2012-07-31 | Terminated(stopped due to it became clear that recruitment was infeasible) |
Quetiapine Pharmacotherapy for Cannabis Dependence [NCT01697709] | Phase 2 | 130 participants (Actual) | Interventional | 2012-10-01 | Completed |
Divalproex Extended Release and Placebo, Lithium, or Quetiapine for Mania [NCT00183443] | Phase 3 | 75 participants (Actual) | Interventional | 2005-02-28 | Completed |
CSP #2015 - Multicenter, Randomized, Double-blind Comparator Study of Antipsychotics Pimavanserin and Quetiapine for Parkinson''s Disease Psychosis (C-SAPP) [NCT04373317] | Phase 4 | 358 participants (Anticipated) | Interventional | 2022-10-24 | Recruiting |
"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) | Observational | 2020-07-13 | Completed |
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 2 | 107 participants (Actual) | Interventional | 2017-12-12 | Completed |
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) | Interventional | 2007-07-31 | Completed |
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) | Interventional | 2007-06-30 | Completed |
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) | Interventional | 2007-04-30 | Completed |
Quetiapine Plus Topiramate or Placebo for Bipolar Mania & Cannabis Use in Adolescents [NCT00393978] | Phase 4 | 75 participants (Actual) | Interventional | 2006-11-30 | Completed |
A Single-Blind, Randomized, Naturalistic Pilot Study, Comparison of Divalproex ER and Quetiapine for Adults With Acute Mania or Mixed Episodes [NCT00397020] | Phase 4 | 30 participants (Actual) | Interventional | 2006-12-31 | Completed |
Quetiapine Augmentation to SRIs for Patients With Obsessive Compulsive Disorder, a Double-blind, Placebo-controlled Study [NCT00318539] | Phase 2 | 90 participants | Interventional | 2003-12-31 | Completed |
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 3 | 800 participants (Anticipated) | Interventional | 2006-05-31 | Completed |
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 3 | 450 participants (Anticipated) | Interventional | 2006-04-30 | Completed |
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 3 | 310 participants (Actual) | Interventional | 2006-04-30 | Completed |
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 2 | 9 participants (Actual) | Interventional | 2015-05-31 | Terminated(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 3 | 22 participants (Actual) | Interventional | 2015-02-18 | Completed |
Long-term Study of FK949E in Elderly Patients -Long-term Study in Elderly Bipolar Disorder Patients With Major Depressive Episodes- [NCT01737268] | Phase 3 | 20 participants (Actual) | Interventional | 2012-10-29 | Completed |
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 3 | 447 participants (Actual) | Interventional | 2007-01-31 | Completed |
An Open-Label Study of Quetiapine Added to Oros Methylphenidate in the Treatment of ADHD and Aggressive Behavior [NCT00550147] | Phase 2 | 30 participants (Actual) | Interventional | 2004-02-29 | Completed |
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 4 | 0 participants (Actual) | Interventional | 2006-10-31 | Withdrawn |
Efficacy of Quetiapine for Pediatric Delirium [NCT02056171] | Phase 1/Phase 2 | 6 participants (Actual) | Interventional | 2015-03-31 | Terminated(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) | Observational | 2020-11-05 | Recruiting |
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 3 | 210 participants (Actual) | Interventional | 2018-04-09 | Completed |
Developing a Single Patient Open-label Trial Tapering Algorithm for Antipsychotics in Long-Term Care - A Pilot Study [NCT02958800] | | 20 participants (Anticipated) | Interventional | 2016-12-31 | Recruiting |
A Pragmatic Randomized Trial Comparing Antipsychotics in Lewy Body Disease [NCT05590637] | Phase 4 | 94 participants (Anticipated) | Interventional | 2022-04-22 | Recruiting |
Quetiapine for Bipolar Disorder and Alcohol Dependence [NCT00457197] | Phase 4 | 90 participants (Actual) | Interventional | 2007-03-31 | Completed |
Efficacy of Hydroxyzine Versus Treatment as Usual for Panic Disorder: An Eight-Week, Open Label, Pilot, Randomized Controlled Trial. [NCT05737511] | Phase 4 | 80 participants (Anticipated) | Interventional | 2023-12-30 | Not 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 3 | 40 participants (Anticipated) | Interventional | 2008-12-31 | Active, not recruiting |
Pharmacovigilance in Gerontopsychiatric Patients [NCT02374567] | Phase 3 | 407 participants (Actual) | Interventional | 2015-01-31 | Terminated |
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 2 | 20 participants (Actual) | Interventional | 2010-09-30 | Completed |
Sequential Multiple Assignment Randomized Treatment (SMART) for Bipolar Disorder [NCT01588457] | Phase 4 | 112 participants (Actual) | Interventional | 2011-06-30 | Completed |
Drug Use-results Survey on Quetiapine Extended-release Tablets in Patients With Depression in Bipolar Disorder [NCT03403790] | | 369 participants (Actual) | Observational | 2018-01-15 | Completed |
Quetiapine Compared With Placebo in the Management of Fibromyalgia [NCT01458964] | Phase 4 | 42 participants (Actual) | Interventional | 2008-01-31 | Completed |
Comparison of Trazodone vs Quetiapine vs Placebo for the Treatment of ICU Delirium: A Randomized Controlled Trial (The TraQ Study) [NCT05085808] | Phase 4 | 30 participants (Anticipated) | Interventional | 2024-03-01 | Not 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 4 | 72 participants (Actual) | Interventional | 2006-05-31 | Completed |
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 2 | 224 participants (Actual) | Interventional | 2007-12-31 | Completed |
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 3 | 431 participants (Actual) | Interventional | 2012-02-07 | Completed |
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 4 | 224 participants (Actual) | Interventional | 2007-07-31 | Completed |
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 3 | 488 participants (Actual) | Interventional | 2008-10-31 | Completed |
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) | Interventional | 2009-09-30 | Completed |
Mirtazapine and Quetiapine as Treatment for Postoperative Sleep Disturbance After Fast-track Knee Replacement [NCT04728581] | | 165 participants (Anticipated) | Interventional | 2024-01-01 | Not 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 4 | 24 participants (Actual) | Interventional | 2017-01-20 | Completed |
1/2-MC4R Genotype and Pediatric Antipsychotic Drug- Induced Weight Gain [NCT01844700] | Phase 4 | 14 participants (Actual) | Interventional | 2013-07-31 | Terminated(stopped due to very slow recruitment, no sufficient results) |
Clinical Management of Metabolic Problems in Patients With Schizophrenia [NCT00423878] | Phase 4 | 215 participants (Actual) | Interventional | 2007-01-31 | Completed |
Quetiapine Plus Topiramate or Placebo for Bipolar Mania & Alcohol Use in Adolescents & Young Adults [NCT00550394] | Phase 4 | 56 participants (Actual) | Interventional | 2008-04-30 | Completed |
An Open Label Study of Seroquel SR® (Quetiapine) for the Treatment of Refractory and Treatment Resistant Functional Bowel Disorders [NCT00617396] | | 25 participants (Actual) | Interventional | 2008-02-29 | Completed |
A Double-Blind, Placebo-Controlled Trial of the Efficacy of Quetiapine for the Reduction of Cocaine Use [NCT00631748] | | 60 participants (Actual) | Interventional | 2008-02-29 | Completed |
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 4 | 1 participants (Actual) | Interventional | 2008-09-30 | Terminated(stopped due to Terminated: recruiting or enrolling participants has halted prematurely) |
Improving Metabolic Parameters of Antipsychotic Child Treatment (IMPACT) [NCT00806234] | Phase 4 | 127 participants (Actual) | Interventional | 2009-01-31 | Completed |
Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-reference, Flexible-dose Study of Brexpiprazole in Patients With Acute Schizophrenia [NCT01810380] | Phase 3 | 468 participants (Actual) | Interventional | 2013-03-31 | Completed |
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 4 | 203 participants (Actual) | Interventional | 2005-10-31 | Completed |
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) | Interventional | 2021-04-10 | Recruiting |
NMDA Antagonists in Bipolar Depression [NCT01833897] | Phase 4 | 8 participants (Actual) | Interventional | 2013-03-31 | Completed |
Cognitive Control and Functional Connectivity During Resting State in Patients With Heightened Risk of Bipolar Disorder - a Quetiapine Challenge [NCT02451306] | | 54 participants (Anticipated) | Interventional | 2015-06-30 | Not yet recruiting |
Effectiveness of Switching Antipsychotic Medications [NCT00044655] | Phase 4 | 219 participants (Actual) | Interventional | 2001-07-31 | Completed |
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Trial | Outcome |
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
Intervention | participants (Number) |
---|
Stay | 11 |
Switch | 23 |
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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)
Intervention | participants (Number) |
---|
Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine | 4 |
Placebo Augmentation of Continued Paroxetine | 2 |
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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)
Intervention | participants (Number) |
---|
Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine | 6 |
Placebo Augmentation of Continued Paroxetine | 5 |
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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)
Intervention | units on a scale (Mean) |
---|
| Baseline (Week 10) | Endpoint (Week 18) |
---|
Placebo Augmentation of Continued Paroxetine | 12.36 | 11.64 |
,Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine | 11.45 | 10.27 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | Week 18 | Change |
---|
Placebo Augmentation of Continued Paroxetine | 15.82 | 15.55 | -0.3 |
,Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine | 16.27 | 13.64 | -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)
Intervention | units on a scale (Mean) |
---|
| Baseline (Week 10) | Endpoint (Week 18) |
---|
Placebo Augmentation of Continued Paroxetine | 45.89 | 45.11 |
,Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine | 45.13 | 46.25 |
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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
Intervention | Drinking Days per Week (Mean) |
---|
QUET | 2.7 |
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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
Intervention | Units on a scale (Mean) |
---|
QUET | 65.5 |
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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
Intervention | Number of clinical events (Mean) |
---|
Risperidone LAI | 0.86 |
Oral AAP | 1.61 |
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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
Intervention | participants (Number) |
---|
Risperidone LAI | 0 |
Oral AAP | 0 |
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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
Intervention | participants (Number) |
---|
Risperidone LAI | 0 |
Oral AAP | 0 |
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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
Intervention | kg / m^2 (Mean) |
---|
| Baseline | Final |
---|
Oral AAP | 29.86 | 32.0 |
,Risperidone LAI | 31.05 | 32.27 |
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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
Intervention | Units 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
Intervention | units on a scale (Mean) |
---|
DVP + Placebo | 5.7 |
DVP + Quetiapine | 11.1 |
DVP + Lithium | 10.0 |
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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
Intervention | units on a scale (Mean) |
---|
DVP + Placebo | 68.3 |
DVP + Quetiapine | 62.3 |
DVP + Lithium | 60.8 |
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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
Intervention | units on a scale (Mean) |
---|
DVP + Placebo | 1.58 |
DVP + Quetiapine | 2.54 |
DVP + Lithium | 2.32 |
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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
Intervention | units on a scale (Mean) |
---|
DVP + Placebo | 13.2 |
DVP + Quetiapine | 18.3 |
DVP + Lithium | 18.8 |
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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
Intervention | units on a scale (Mean) |
---|
DVP + Placebo | 68.2 |
DVP + Quetiapine | 62.1 |
DVP + Lithium | 59.8 |
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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
Intervention | percentage of participants (Number) |
---|
Quetiapine/Seroquel | 47 |
Placebo | 21 |
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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
Intervention | percentage of participants (Number) |
---|
Quetiapine/Seroquel | 37 |
Placebo | 21 |
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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
Intervention | percentage of participants (Number) |
---|
Quetiapine/Seroquel | 47 |
Placebo | 29 |
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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
Intervention | units on scale (Mean) |
---|
Quetiapine Fumarate | 1.2 |
Risperidone | 0.9 |
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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
Intervention | units 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
Intervention | Participants with P type event (Number) |
---|
Quetiapine Fumarate | 4 |
Risperidone | 7 |
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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
Intervention | units of scale (Mean) |
---|
Quetiapine Fumarate | -0.1 |
Risperidone | 0.1 |
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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
Intervention | units 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
Intervention | units on scale (Mean) |
---|
Quetiapine Fumarate | -0.2 |
Risperidone | 0.1 |
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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
Intervention | units 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
Intervention | units 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
Intervention | units 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
Intervention | Participants (Number) |
---|
Quetiapine Fumarate | 73 |
Risperidone | 106 |
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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
Intervention | Relapses (Number) |
---|
Quetiapine Fumarate | 24 |
Risperidone | 33 |
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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
Intervention | units 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
Intervention | Participants with C type event (Number) |
---|
Quetiapine Fumarate | 2 |
Risperidone | 8 |
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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
Intervention | Participants with N type event (Number) |
---|
Quetiapine Fumarate | 0 |
Risperidone | 2 |
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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)
Intervention | days (Mean) |
---|
Risperidone LAI | 607 |
Quetiapine | 533 |
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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)
Intervention | days (Mean) |
---|
Aripiprazole | 314 |
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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)
Intervention | units 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)
Intervention | units on a scale (Mean) |
---|
Risperidone LAI | -0.3 |
Quetiapine | 0.1 |
Aripiprazole | -0.1 |
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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
Intervention | Participants (Number) |
---|
Quetiapine | 37 |
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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
Intervention | Participants (Number) |
---|
Quetiapine | 34 |
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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
Intervention | Participants (Number) |
---|
Quetiapine | 11 |
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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
Intervention | Participants (Number) |
---|
Quetiapine | 321 |
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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
Intervention | Participants (Number) |
---|
Quetiapine | 70 |
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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
Intervention | Participants (Number) |
---|
Quetiapine | 19 |
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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
Intervention | mmHg (Mean) |
---|
Quetiapine | 1.7 |
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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
Intervention | mmHg (Mean) |
---|
Quetiapine | 1.3 |
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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
Intervention | Participants (Number) |
---|
Quetiapine | 134 |
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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
Intervention | bpm (Mean) |
---|
Quetiapine | 0.8 |
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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
Intervention | units on a scale (Mean) |
---|
Quetiapine | 7 |
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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)
Intervention | units on a scale (Mean) |
---|
| Baseline Q-LES-Q | Endpoint Q-LES-Q |
---|
Arm 2 OL Paroxetine + DB Placebo | 37.85 | 38.22 |
,Arm 3: OL Paroxetine + DB Quetiapine | 40.44 | 41.06 |
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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)
Intervention | units on a scale (Mean) |
---|
| Baseline SDS-WS | Endpoint SDS-WS | Baseline SDS-SL | Endpoint SDS-SL | Baseline SDS-FL | Endpoint SDS-FL |
---|
Arm 2 OL Paroxetine + DB Placebo | 5.07 | 4.58 | 6.67 | 5.92 | 5.85 | 5.39 |
,Arm 3: OL Paroxetine + DB Quetiapine | 4.44 | 4.66 | 5.64 | 4.95 | 4.72 | 4.61 |
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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)
Intervention | units on a scale (Mean) |
---|
| Baseline PSQI | Endpoint PSQI |
---|
Arm 2 OL Paroxetine + DB Placebo | 11.60 | 8.70 |
,Arm 3: OL Paroxetine + DB Quetiapine | 12.69 | 13.19 |
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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)
Intervention | units on a scale (Mean) |
---|
| Baseline CGI-I | Endpoint CGI-I |
---|
Arm 2 OL Paroxetine + DB Placebo | 3.56 | 2.61 |
,Arm 3: OL Paroxetine + DB Quetiapine | 3.36 | 2.22 |
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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)
Intervention | units on a scale (Mean) |
---|
| CAPS Total Baseline | CAPS Total Endpoint |
---|
Arm 2 OL Paroxetine + DB Placebo | 72.15 | 67.90 |
,Arm 3: OL Paroxetine + DB Quetiapine | 68.78 | 51.52 |
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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)
Intervention | units on a scale (Mean) |
---|
| Baseline ASEX | Endpoint ASEX |
---|
Arm 2 OL Paroxetine + DB Placebo | 22.00 | 21.93 |
,Arm 3: OL Paroxetine + DB Quetiapine | 17.88 | 16.94 |
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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)
Intervention | units on a scale (Mean) |
---|
| Baseline Total PANSS | Endpoint Total PANSS |
---|
Arm 2 OL Paroxetine + DB Placebo | 46.63 | 43.92 |
,Arm 3: OL Paroxetine + DB Quetiapine | 47.76 | 42.24 |
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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)
Intervention | units on a scale (Mean) |
---|
| Baseline HAMD | Endpoint HAMD |
---|
Arm 2 OL Paroxetine + DB Placebo | 14.60 | 12.29 |
,Arm 3: OL Paroxetine + DB Quetiapine | 13.84 | 9.29 |
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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)
Intervention | units on a scale (Mean) |
---|
| Baseline DTS | Endpoint DTS |
---|
Arm 2 OL Paroxetine + DB Placebo | 82.19 | 84.06 |
,Arm 3: OL Paroxetine + DB Quetiapine | 77.25 | 61.50 |
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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
Intervention | units on a scale (Least Squares Mean) |
---|
Injectable | 1.8 |
Oral | 2.0 |
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Number of Patients Discontinuing From the Study
(NCT00330863)
Timeframe: Measured throughout study up to 30 months
Intervention | participants (Number) |
---|
Injectable | 81 |
Oral | 80 |
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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
Intervention | units on scale (Median) |
---|
Quetiapine XR | 0 |
Placebo | 0 |
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Tolerability as Measured by Adverse Event Withdrawals During Treatment
(NCT00388973)
Timeframe: Baseline to Week 9
Intervention | Participants (Number) |
---|
Quetiapine XR | 16 |
Placebo | 7 |
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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
Intervention | units 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
Intervention | units 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
Intervention | units 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
Intervention | units 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
Intervention | units on scale (Median) |
---|
Quetiapine XR | 0 |
Placebo | 0 |
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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
Intervention | units 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
Intervention | units 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
Intervention | Number of participants. (Number) |
---|
Quetiapine XR | 152 |
Placebo | 54 |
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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
Intervention | Number of participants. (Number) |
---|
Quetiapine XR | 89 |
Placebo | 29 |
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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
Intervention | Patients (Number) |
---|
Quetiapine XR | 12.00 |
Placebo | 5.00 |
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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
Intervention | Participants (Number) |
---|
Quetiapine XR | 145.00 |
Placebo | 114.00 |
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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
Intervention | units 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
Intervention | units 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
Intervention | units 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
Intervention | mm (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
Intervention | cannabis 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
Intervention | joints (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
Intervention | units on a scale (Mean) |
---|
1 Divalproex ER | 14.8 |
2 Quetiapine Fumarate | 13.9 |
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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
Intervention | Participants (Count of Participants) |
---|
Psychotherapy | 4 |
Medication | 3 |
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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
Intervention | participants (Number) |
---|
| 50% reduction in HRSD 25 score and YMRS <= 10 | Non-responder |
---|
Medication | 3 | 8 |
,Psychotherapy | 4 | 10 |
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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
Intervention | Participants (Count of Participants) |
---|
Psychotherapy | 11 |
Medication | 8 |
Total | 19 |
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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
Intervention | participants (Number) |
---|
Switch Group | 22 |
Stay Group | 18 |
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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
Intervention | mg/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.
Intervention | units on a scale (Mean) |
---|
| ISI (baseline) | ISI (week 7) |
---|
Placebo | 14.80 | 6.70 |
,Quetiapine XR | 17.00 | 5.40 |
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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.
Intervention | units on a scale (Mean) |
---|
| PSQI (baseline) | PSQI (week 4) | PSQI (week 9) |
---|
Placebo | 14.60 | 13.80 | 13.80 |
,Quetiapine XR | 14.70 | 13.20 | 14.50 |
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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
Intervention | minutes (Mean) |
---|
| WASO (baseline) | WASO (week 8) |
---|
Placebo | 61.17 | 66.99 |
,Quetiapine XR | 101.87 | 60.71 |
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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.
Intervention | percentage (Mean) |
---|
| Sleep Efficiency (baseline) | Sleep Efficiency (after 8 weeks of treatment) |
---|
Placebo | 78.63 | 82.80 |
,Quetiapine XR | 70.70 | 79.45 |
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The Number of Standard Drinks/Day Will Serve as the Primary Outcome Measure.
(NCT00457197)
Timeframe: 12 weeks
Intervention | drinks (Least Squares Mean) |
---|
Placebo | 10.6 |
Quetiapine | 8.09 |
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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
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | 8.70 |
Quetiapine | 8.48 |
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Aspartate Aminotransferase (AST)
AST is a liver enzyme measurement (IU/I) (NCT00457197)
Timeframe: 12 weeks
Intervention | IU/I (Least Squares Mean) |
---|
Placebo | 29.7 |
Quetiapine | 31.1 |
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Alanine Aminotransferase (ALT)
ALT is a liver enzyme measurement (IU/I). (NCT00457197)
Timeframe: 12 weeks
Intervention | IU/I (Least Squares Mean) |
---|
Placebo | 25.1 |
Quetiapine | 30.4 |
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Gamma-glutamyltransferase (GGT)
GGT is a liver enzyme measurement (IU/I) (NCT00457197)
Timeframe: 12 weeks
Intervention | IU/I (Least Squares Mean) |
---|
Placebo | 66.6 |
Quetiapine | 66.0 |
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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
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | 10.9 |
Quetiapine | 10.3 |
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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
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | 19.0 |
Quetiapine | 21.9 |
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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
Intervention | units on a scale (Least Squares Mean) |
---|
Placebo | 14.1 |
Quetiapine | 12.3 |
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Percent of Heavy Drinking Days
(NCT00457197)
Timeframe: 12 weeks
Intervention | drinks (Least Squares Mean) |
---|
Placebo | 28.8 |
Quetiapine | 20.8 |
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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
Intervention | score 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
Intervention | score on a scale (Least Squares Mean) |
---|
Quetiapine Fumerate Plus Medical Management | 2.4 |
Sugar Pill Plus Medical Management | 3.0 |
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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
Intervention | drinks per drinking day (Least Squares Mean) |
---|
Quetiapine Fumerate Plus Medical Management | 6.2 |
Sugar Pill Plus Medical Management | 6.3 |
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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
Intervention | drinks per day (Least Squares Mean) |
---|
Quetiapine Fumerate Plus Medical Management | 4.3 |
Sugar Pill Plus Medical Management | 4.4 |
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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
Intervention | score on a scale (Least Squares Mean) |
---|
Quetiapine Fumerate Plus Medical Management | 18.5 |
Sugar Pill Plus Medical Management | 22.5 |
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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
Intervention | Participants (Count of Participants) |
---|
Quetiapine Fumerate Plus Medical Management | 12 |
Sugar Pill Plus Medical Management | 12 |
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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
Intervention | score on a scale (Least Squares Mean) |
---|
Quetiapine | 51.0 |
Placebo | 50.6 |
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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
Intervention | Participants (Count of Participants) |
---|
Quetiapine Fumerate Plus Medical Management | 17 |
Sugar Pill Plus Medical Management | 24 |
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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
Intervention | score on a scale (Least Squares Mean) |
---|
Quetiapine Fumerate Plus Medical Management | 51.5 |
Sugar Pill Plus Medical Management | 50.7 |
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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
Intervention | percentage heavy drinking days (Least Squares Mean) |
---|
Quetiapine Fumerate Plus Medical Management | 16.5 |
Sugar Pill Plus Medical Management | 18.8 |
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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
Intervention | score (Least Squares Mean) |
---|
Quetiapine Fumerate Plus Medical Management | 4.1 |
Sugar Pill Plus Medical Management | 5.1 |
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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
Intervention | percentage of heavy drinking days (Least Squares Mean) |
---|
Quetiapine Fumerate Plus Medical Management | 37.1 |
Sugar Pill Plus Medical Management | 37.9 |
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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
Intervention | percentage of days abstinent (Least Squares Mean) |
---|
Quetiapine Fumerate Plus Medical Management | 49.5 |
Sugar Pill Plus Medical Management | 47.1 |
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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
Intervention | score on a scale (Mean) |
---|
Quetiapine Fumerate Plus Medical Management | 12.1 |
Sugar Pill Plus Medical Management | 12.8 |
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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
Intervention | score on a scale (Least Squares Mean) |
---|
Quetiapine Fumerate Plus Medical Management | 2.8 |
Sugar Pill Plus Medical Management | 4.1 |
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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
Intervention | participants (Number) |
---|
Control Group | 22 |
Aripiprazole | 16 |
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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
Intervention | percent change (Mean) |
---|
Control Group | 10.06 |
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
Intervention | units on a scale (Mean) |
---|
| Baseline | Week 4 | Week 8 | Week 12 | Week 16 |
---|
Galantamine and CDP-choline Group | 4.32 | 4 | 3.67 | 3.87 | 3.8 |
,Placebo Group | 4.38 | 3.92 | 4.04 | 4 | 3.68 |
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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
Intervention | raw scores (Mean) |
---|
| Baseline | Week 8 | Week 16 |
---|
Galantamine and CDP-choline Group | 20.5 | 21.8 | 23.0 |
,Placebo Group | 20.6 | 21.2 | 20.4 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | Week 4 | Week 8 | Week 12 | Week 16 |
---|
Galantamine/CDP Choline | 17.63 | 17.06 | 13.93 | 14.93 | 13.93 |
,Placebos for Galantamine/CDP Choline | 18.29 | 17.08 | 17.26 | 17.32 | 16.05 |
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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.
Intervention | kilograms of body fat (Mean) |
---|
| Baseline | 6 Weeks | 12 Weeks |
---|
Olanzapine | 32.24 | 34.38 | 35.45 |
,Quetiapine | 28.83 | 29.60 | 30.10 |
,Risperidone | 27.66 | 28.29 | 29.23 |
,Total | 30.25 | 31.05 | 31.52 |
,Ziprasidone | 31.60 | 31.18 | 30.66 |
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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.
Intervention | mg/kg/min (Mean) |
---|
| Baseline | Week 12 |
---|
Olanzapine | 4.39 | 3.62 |
,Quetiapine | 5.28 | 5.08 |
,Risperidone | 5.53 | 5.01 |
,Total | 4.82 | 4.50 |
,Ziprasidone | 4.33 | 4.45 |
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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)
Intervention | Units on the scale (Mean) |
---|
Placebo | NA |
Quetiapine | NA |
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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)
Intervention | Units on the scale (Mean) |
---|
| Trait | State |
---|
Placebo | NA | NA |
,Quetiapine | NA | NA |
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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)
Intervention | Units on the scale (Mean) |
---|
| Positive Scale | Negative Scale | General Scale |
---|
Placebo | NA | NA | NA |
,Quetiapine | NA | NA | NA |
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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)
Intervention | Hours (Mean) |
---|
| Hours occupied by preoccupations | Hours occupied by rituals |
---|
Placebo | NA | NA |
,Quetiapine | NA | NA |
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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)
Intervention | Units on the scale (Mean) |
---|
Placebo | NA |
Quetiapine | NA |
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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
Intervention | Scores on a scale (Mean) |
---|
Quetiapine 600 mg | 0.31 |
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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
Intervention | Scores 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
Intervention | Scores on a scale (Mean) |
---|
Quetiapine 600 mg | 1.67 |
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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
Intervention | Scores on a scale (Mean) |
---|
Quetiapine 600 mg | 1.78 |
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Change in Weight From Baseline to Final Visit or Last Observation Carried Forward (LOCF).
(NCT00521365)
Timeframe: Baseline and 3 weeks
Intervention | Kg (Mean) |
---|
Quetiapine 600 mg | 0.27 |
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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
Intervention | cm (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
Intervention | Participants (Number) |
---|
Quetiapine 600 mg | 81 |
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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
Intervention | Participants (Number) |
---|
Quetiapine 600 mg | 49 |
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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
Intervention | Participants (Number) |
---|
Quetiapine 600 mg | 1 |
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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
Intervention | Scores 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
Intervention | Scores 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
Intervention | Scores 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
Intervention | Scores on a scale (Mean) |
---|
Quetiapine 600 mg | 1.16 |
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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
Intervention | Scores on a scale (Mean) |
---|
Quetiapine 600 mg | 27.73 |
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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
Intervention | units 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
Intervention | Participants (Number) |
---|
Quetiapine XR | 84 |
Placebo | 72 |
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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
Intervention | Participants (Number) |
---|
Quetiapine XR | 33 |
Placebo | 22 |
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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
Intervention | Participants (Number) |
---|
Quetiapine XR | 48 |
Placebo | 34 |
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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
Intervention | Participants (Number) |
---|
Quetiapine XR | 114 |
Placebo | 97 |
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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
Intervention | LS 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
Intervention | LS 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
Intervention | Mean change from randomization (Mean) |
---|
Quetiapine XR | 0.30 |
Placebo | 0.40 |
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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
Intervention | LS 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
Intervention | LS 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
Intervention | LS 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
Intervention | LS mean change from randomization (Least Squares Mean) |
---|
Quetiapine XR | 7.33 |
Placebo | 6.43 |
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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
Intervention | LS 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
Intervention | LS 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
Intervention | Mean change from randomization (Mean) |
---|
Quetiapine XR | 0.30 |
Placebo | 0.20 |
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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
Intervention | units on a scale (Mean) |
---|
Baseline | 19.0 |
Visit 5 - MPH Monotherapy - Week 4 | 14.5 |
Visit 10 - MPH+Quetiapine - Week 13 | 10.3 |
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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
Intervention | units on a scale (Mean) |
---|
Baseline | 5.3 |
Visit 5 - MPH Monotherapy - Week 4 | 4.1 |
Visit 10 - MPH + Quetiapine - Week 13 | 2.8 |
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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
Intervention | units on a scale (Mean) |
---|
Baseline | 4.3 |
Visit 5 - MPH Monotherapy - Week 4 | 3.2 |
Visit 10 - MPH+Quetiapine - Week 13 | 2.0 |
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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
Intervention | units on a scale (Mean) |
---|
Baseline | 45.7 |
Visit 5 - MPH Monotherapy - Week 4 | 32.7 |
Visit 10 - MPH+Quetiapine - Week 13 | 19.4 |
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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
Intervention | units on a scale (Mean) |
---|
Baseline | 229.0 |
Visit 5 - MPH Monotherapy - Week 4 | 73.7 |
Visit 10 - MPH + Quetiapine - Week 13 | 26.3 |
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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)
Intervention | Drinks 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)
Intervention | Drinks 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)
Intervention | Percent 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)
Intervention | Percentage of days abstinent (Mean) |
---|
Quetiapine and Placebo | 15 |
Quetiapine and Topiramate | 14 |
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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
Intervention | score 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
Intervention | score 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
Intervention | score on a scale (Least Squares Mean) |
---|
Quetiapine SR | 3.9 |
Divalproex Sodium ER | 1.9 |
Placebo | 2.3 |
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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
Intervention | score 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
Intervention | score 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
Intervention | score 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
Intervention | score 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
Intervention | score 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)
Intervention | score on a scale (Least Squares Mean) |
---|
Quetiapine SR | 4.9 |
Divalproex Sodium ER | 2.9 |
Placebo | 3.4 |
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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
Intervention | score 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
Intervention | score 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
Intervention | Events (Number) |
---|
Quetiapine XR | 51 |
Risperidone | 112 |
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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
Intervention | Participants (Number) |
---|
Quetiapine XR | 0 |
Risperidone | 10 |
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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
Intervention | Participants (Number) |
---|
Quetiapine XR | 9 |
Risperidone | 13 |
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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
Intervention | Participants (Number) |
---|
Quetiapine XR | 57 |
Risperidone | 48 |
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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
Intervention | Participants (Number) |
---|
Quetiapine XR | 22 |
Risperidone | 17 |
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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
Intervention | Participants (Number) |
---|
Quetiapine XR | 38 |
Risperidone | 83 |
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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
Intervention | Participants (Number) |
---|
Quetiapine XR | 238 |
Risperidone | 258 |
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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
Intervention | Participants (Number) |
---|
Quetiapine XR | 4 |
Risperidone | 20 |
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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
Intervention | Participants with stable state (Number) |
---|
Quetiapine XR | 160 |
Risperidone | 171 |
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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
Intervention | Scores on a scale (Least Squares Mean) |
---|
Quetiapine XR | 22.7 |
Risperidone | 19.4 |
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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
Intervention | Scores on a scale (Least Squares Mean) |
---|
Quetiapine XR | 23.2 |
Risperidone | 21.1 |
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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
Intervention | Scores on a scale (Least Squares Mean) |
---|
Quetiapine XR | 4.5 |
Risperidone | 3.9 |
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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
Intervention | Scores on a scale (Least Squares Mean) |
---|
Quetiapine XR | 4.9 |
Risperidone | 3.9 |
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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
Intervention | Scores on a scale (Least Squares Mean) |
---|
Quetiapine XR | 4.9 |
Risperidone | 4.0 |
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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
Intervention | Scores on a scale (Least Squares Mean) |
---|
Quetiapine XR | 4.1 |
Risperidone | 3.8 |
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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
Intervention | Scores on a scale (Least Squares Mean) |
---|
Quetiapine XR | 4.6 |
Risperidone | 4.0 |
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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
Intervention | Participants (Number) |
---|
Quetiapine XR | 72 |
Risperidone | 63 |
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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
Intervention | Participants (Number) |
---|
Quetiapine XR | 94 |
Risperidone | 70 |
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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
Intervention | Participants (Number) |
---|
Quetiapine XR | 136 |
Risperidone | 158 |
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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
Intervention | Participants (Number) |
---|
Quetiapine XR | 270 |
Risperidone | 249 |
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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
Intervention | Scores on a scale (Mean) |
---|
Quetiapine XR | 3.8 |
Risperidone | 3.9 |
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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
Intervention | Participants (Number) |
---|
Quetiapine XR | 176 |
Risperidone | 178 |
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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
Intervention | Scores 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
Intervention | Participants (Number) |
---|
Quetiapine XR | 43 |
Risperidone | 31 |
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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
Intervention | Days (Mean) |
---|
Quetiapine XR | 10 |
Risperidone | 6.7 |
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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
Intervention | Participants (Number) |
---|
Quetiapine XR | 138 |
Risperidone | 141 |
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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
Intervention | Participants (Number) |
---|
Quetiapine XR | 37 |
Risperidone | 21 |
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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
Intervention | Days (Mean) |
---|
Quetiapine XR | 144.3 |
Risperidone | 152.8 |
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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
Intervention | Participants (Number) |
---|
Quetiapine XR | 139 |
Risperidone | 128 |
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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
Intervention | ng/mL (Mean) |
---|
Quetiapine XR | -7.735 |
Risperidone | 15.990 |
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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
Intervention | percentage 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
Intervention | units on a scale (Mean) |
---|
| Decrease in HAM-D scores | Decrease in HAM-A scores | Increase in PSQI sleep quality scores |
---|
Placebo | 3.8 | 5.5 | 1.3 |
,Quetiapine XR | 5.0 | 6.8 | 1.3 |
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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
Intervention | units 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
Intervention | Percentage of Participants (Number) |
---|
Study Drug | 45.5 |
Placebo | 44.4 |
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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)
Intervention | grams of cocaine used (Mean) |
---|
Study Drug | 0.11 |
Placebo | 0.63 |
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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
Intervention | score on scale (Mean) |
---|
Seroquel XR | 102.26 |
Risperidone | 100.51 |
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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
Intervention | KG (Least Squares Mean) |
---|
Seroquel XR | 61.20 |
Risperidone | 90.80 |
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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
Intervention | Participants (Number) |
---|
Seroquel XR | 14 |
Risperidone | 17 |
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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
Intervention | Participants (Number) |
---|
Seroquel XR | 12 |
Risperidone | 11 |
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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
Intervention | Score 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
Intervention | Score 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
Intervention | Kg/m^2 (Mean) |
---|
Seroquel XR | 29.07 |
Risperidone | 28.80 |
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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
Intervention | score on a scale (Mean) |
---|
Seroquel XR | 91 |
Risperidone | 88 |
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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
Intervention | score on scale (Mean) |
---|
Seroquel XR | 2.74 |
Risperidone | 3.88 |
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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
Intervention | Score on a scale (Least Squares Mean) |
---|
Seroquel XR | 7.31 |
Risperidone | 5.53 |
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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
Intervention | score on scale (Least Squares Mean) |
---|
Seroquel XR | 86.38 |
Risperidone | 76.64 |
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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
Intervention | units on a scale (Mean) |
---|
Seroquel XR | 6.45 |
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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
Intervention | units on a scale (Mean) |
---|
Seroquel XR | 3.67 |
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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
Intervention | units on a scale (Mean) |
---|
Seroquel XR | 2.36 |
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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
Intervention | units on a scale (Mean) |
---|
Seroquel XR | 10.95 |
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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
Intervention | units on a scale (Mean) |
---|
Seroquel XR | 0.55 |
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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)
Intervention | Percentage of Participants (Mean) |
---|
Seroquel XR | 56.88 |
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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
Intervention | percentage of subjects (Number) |
---|
| Improved | Unchanged | Worsened |
---|
Seroquel XR | 28.1 | 63.7 | 8.2 |
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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
Intervention | Percentage of subjects (Number) |
---|
| Improved | Unchanged | Worsened |
---|
Seroquel XR | 46.1 | 43.5 | 10.4 |
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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
Intervention | units on a scale (Mean) |
---|
Seroquel XR | 5.54 |
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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
Intervention | units on a scale (Mean) |
---|
Seroquel XR | 0.51 |
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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
Intervention | units on a scale (Mean) |
---|
Seroquel XR | 1.41 |
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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
Intervention | percentage of slow wave sleep (Mean) |
---|
| percentage at baseline | percentage on the 28th day | percentage change from baseline to the 28th day |
---|
Haloperidol | 8.6 | 6.3 | -2.3 |
,Quetiapine Fumarate | 10.5 | 9.2 | -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
Intervention | percentage of rapid eye movement sleep (Mean) |
---|
| percentage at baseline | percentage on the 28th day | percentage change from baseline to the 28th day |
---|
Haloperidol | 13.2 | 10.4 | -2.7 |
,Quetiapine Fumarate | 12.6 | 16.4 | 3.9 |
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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
Intervention | units 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
Intervention | units 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
Intervention | units on a scale (Mean) |
---|
Quetiapine XR | 0.11 |
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
Intervention | units 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
Intervention | participants (Number) |
---|
Quetiapine XR | 12 |
Placebo for Quetiapine XR | 11 |
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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
Intervention | Participants (Number) |
---|
Quetiapine XR | 6 |
Placebo for Quetiapine XR | 6 |
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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
Intervention | score 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
Intervention | score 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
Intervention | Participants (Number) |
---|
Quetiapine Fumarate Used as Mono-Therapy | 117 |
Quetiapine Fumarate Used as Adjunct Therapy | 123 |
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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
Intervention | Participants (Number) |
---|
Quetiapine Fumarate Used as Mono-Therapy | 139 |
Quetiapine Fumarate Used as Adjunct Therapy | 153 |
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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
Intervention | score 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
Intervention | score 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
Intervention | score 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
Intervention | score 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
Intervention | units 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
Intervention | percent days of heavy drinking (Number) |
---|
Seroquel (Quetiapine) | 20 |
Placebo Sugar Pill | 24 |
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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
Intervention | scores on a HAM-D scale (Mean) |
---|
Quetiapine Fumarate | 21 |
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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)
Intervention | Puffs (Mean) |
---|
Quetiapine, Marijuana | 2.5 |
Placebo, Marijuana | 1.5 |
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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
Intervention | units on a scale (composite t-score) (Mean) |
---|
Quetiapine XR Group | 49.6 |
Placebo Group | 47.8 |
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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
Intervention | score 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
Intervention | score 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
Intervention | score 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
Intervention | score 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
Intervention | score 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
Intervention | score on a scale (Mean) |
---|
Quetiapine XR | 17.9 |
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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
Intervention | score 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
Intervention | units 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
Intervention | units on a scale (Least Squares Mean) |
---|
Lurasidone-Lurasidone | 0.22 |
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
Intervention | units 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
Intervention | participants (Number) |
---|
Lurasidone-Lurasidone | 29 |
Quetiapine-Quetiapine | 21 |
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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
Intervention | Participants (Number) |
---|
Quetiapine XR Mono | 114 |
Add-on Quetiapine XR | 120 |
Add-on Lithium | 102 |
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Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With One Previous Treatment Failure
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 weeks of treatment
Intervention | Participants (Number) |
---|
Quetiapine XR Mono | 54 |
Add-on Quetiapine XR | 65 |
Add-on Lithium | 53 |
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Response Rate; Montgomery-Asberg Depression Rating Scale (MADRS) Score Reduced ≥ 50%, Patients With Two Previous Treatment Failure
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 weeks of treatment
Intervention | Participants (Number) |
---|
Quetiapine XR Mono | 60 |
Add-on Quetiapine XR | 55 |
Add-on Lithium | 49 |
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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
Intervention | Participants (Number) |
---|
Quetiapine XR Mono | 135 |
Add-on Quetiapine XR | 146 |
Add-on Lithium | 131 |
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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
Intervention | Scores 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
Intervention | Scores on a scale (Least Squares Mean) |
---|
Quetiapine XR Mono | -0.62 |
Add-on Quetiapine XR | 0.014 |
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
Intervention | scores 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
Intervention | scores 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 (CGI) Item 4 Efficacy and Safety Combined, Patients With One Previous Treatment Failure
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. (NCT00789854)
Timeframe: 6 weeks of treatment
Intervention | Participants (Number) |
---|
Quetiapine XR Mono | 67 |
Add-on Quetiapine XR | 75 |
Add-on Lithium | 69 |
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Change in Clinical Global Impression (CGI) Item 4 Efficacy and Safety Combined, Patients With Two Previous Treatment Failures
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. (NCT00789854)
Timeframe: 6 week of treatments
Intervention | Participants (Number) |
---|
Quetiapine XR Mono | 68 |
Add-on Quetiapine XR | 71 |
Add-on Lithium | 62 |
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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
Intervention | scores 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 Clinical Global Impression Scale (CGI-S), Patients With One Previous Treatment Failure
Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale from 1-7, where a lower value shows a larger improvement. (NCT00789854)
Timeframe: 6 weeks of treatment
Intervention | scores on a scale (Least Squares Mean) |
---|
Quetiapine XR Mono | -1.45 |
Add-on Quetiapine XR | -1.82 |
Add-on Lithium | -1.59 |
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Change in Clinical Global Impression Scale (CGI-S), Patients With Two Previous Treatment Failure
Change in severity of illness measured by Clinical Global Impression Scale (CGI-S). Scale from 1-7, where a lower value shows a larger improvement. (NCT00789854)
Timeframe: 6 weeks of treatment
Intervention | scores on a scale (Least Squares Mean) |
---|
Quetiapine XR Mono | -1.52 |
Add-on Quetiapine XR | -1.55 |
Add-on Lithium | -1.45 |
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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
Intervention | scores 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
Intervention | scores 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
Intervention | scores 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
Intervention | Scores on a scale (Least Squares Mean) |
---|
Quetiapine XR Mono | 0.184 |
Add-on Quetiapine XR | 0.224 |
Add-on Lithium | 0.208 |
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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
Intervention | MADRS 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
Intervention | Scores 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
Intervention | Scores 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) ≤10, Patients With One Previous Treatment Failure
Number of patients in remission with one previous treatment failure and 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
Intervention | Participants (Number) |
---|
Quetiapine XR Mono | 22 |
Add-on Quetiapine XR | 42 |
Add-on Lithium | 31 |
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Depression Remission; Montgomery-Asberg Depression Rating Scale (MADRS) ≤10, Patients With Two Previous Treatment Failure
Number of patients in remission with two previous treatment failure and 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
Intervention | Participants (Number) |
---|
Quetiapine XR Mono | 31 |
Add-on Quetiapine XR | 31 |
Add-on Lithium | 29 |
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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
Intervention | Participants (Number) |
---|
Quetiapine XR Mono | 67 |
Add-on Quetiapine XR | 89 |
Add-on Lithium | 73 |
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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
Intervention | Participants (Number) |
---|
Quetiapine XR Mono | 35 |
Add-on Quetiapine XR | 58 |
Add-on Lithium | 45 |
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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
Intervention | Participants (Number) |
---|
Quetiapine XR Mono | 53 |
Add-on Quetiapine XR | 73 |
Add-on Lithium | 60 |
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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
Intervention | scores on a scale (Mean) |
---|
Quetiapine XR Mono | -1.54 |
Add-on Quetiapine XR | -1.85 |
Add-on Lithium | -1.58 |
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Responder: Clinical Global Impression Improvement (CGI-I) Item 2, Patients With Two Previous Treatment Failure
Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where a lower value shows a larger improvement. (NCT00789854)
Timeframe: 6 weeks of treatment
Intervention | scores on a scale (Mean) |
---|
Quetiapine XR Mono | -1.67 |
Add-on Quetiapine XR | -1.79 |
Add-on Lithium | -1.54 |
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Responder: Clinical Global Impression Improvement (CGI)-I Item 2, Patients With One Previous Treatment Failure
Change in global improvement measured by Clinical Global Impression Improvement (CGI-I). Scale from 1-4, where a lower value shows a larger improvement. (NCT00789854)
Timeframe: 6 weeks of treatment
Intervention | scores on a scale (Mean) |
---|
Quetiapine XR Mono | -1.42 |
Add-on Quetiapine XR | -1.91 |
Add-on Lithium | -1.62 |
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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
Intervention | scores 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
Intervention | scores 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
Intervention | mg/dL (Least Squares Mean) |
---|
Healthy Lifestyle Information | 0.2 |
Switch Treatment + Healthy Lifestyle Instruction | 16.6 |
Metformin Treatment + Healthy Lifestyle Instruction | 14.7 |
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Body Mass Index (BMI) Z-score Change
(NCT00806234)
Timeframe: Change from baseline to 24 weeks
Intervention | Z Score (Least Squares Mean) |
---|
Healthy Lifestyle Information | 0.040 |
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
Intervention | mg/dL (Least Squares Mean) |
---|
Healthy Lifestyle Information | 3.6 |
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
Intervention | mU/L (Least Squares Mean) |
---|
Healthy Lifestyle Information | 0.74 |
Switch Treatment + Healthy Lifestyle Instruction | 0.42 |
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
Intervention | participants (Number) |
---|
Quetiapine XR | 58 |
Placebo | 55 |
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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
Intervention | Proportions (Number) |
---|
Quetiapine XR | 0.522 |
Placebo | 0.40 |
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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
Intervention | Scores 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
Intervention | participants (Number) |
---|
Quetiapine XR | 42 |
Placebo | 34 |
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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
Intervention | Scores 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
Intervention | Scores on a scale (Least Squares Mean) |
---|
Quetiapine XR | 2.4 |
Placebo | 2.6 |
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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
Intervention | Scores on a scale (Mean) |
---|
Seroquel XR | 3.2 |
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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
Intervention | Scores on a scale (Mean) |
---|
| Day 1 (Baseline) (n= 28) | Day 42 (n= 17) |
---|
Seroquel XR | 4.6 | 2.7 |
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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
Intervention | Scores on a scale (Mean) |
---|
| Day 1 (Baseline) (n= 28) | Day 42 (n= 17) |
---|
Seroquel XR | 85.3 | 48.5 |
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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
Intervention | score 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
Intervention | score 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
Intervention | Participants (Number) |
---|
Quetiapine Extended Release | 4 |
Setraline | 4 |
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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
Intervention | Participants (Number) |
---|
Quetiapine Extended Release | 6 |
Setraline | 5 |
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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
Intervention | Participants (Number) |
---|
Quetiapine Extended Release | 6 |
Setraline | 5 |
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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
Intervention | Participants (Number) |
---|
Quetiapine Extended Release | 3 |
Setraline | 3 |
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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
Intervention | Participants (Number) |
---|
Quetiapine Extended Release | 3 |
Setraline | 4 |
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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
Intervention | Participants (Number) |
---|
Quetiapine Extended Release | 8 |
Setraline | 2 |
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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
Intervention | Participants (Number) |
---|
Quetiapine Extended Release | 8 |
Setraline | 6 |
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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
Intervention | Participants (Number) |
---|
Quetiapine Extended Release | 8 |
Setraline | 5 |
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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
Intervention | score 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
Intervention | score 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
Intervention | score 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
Intervention | score 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
Intervention | score 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
Intervention | score on a scale (Mean) |
---|
Quetiapine Extended Release | -13.4 |
Setraline | -8.9 |
[back to top]
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
Intervention | score 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
Intervention | score 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)
Intervention | mg/dL (Mean) |
---|
Aripiprazole | 176.07 |
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
Intervention | Percentage of change (Mean) |
---|
| Week 4 | Week 8 | Week 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
Intervention | Participants (Number) |
---|
| Deaths | SAEs | AEs leading to discontinuation | 1 or more AEs |
---|
Aripiprazole | 0 | 2 | 3 | 11 |
,Control Group (Olanzapine, Risperidone, or Quetiapine) | 0 | 0 | 0 | 6 |
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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
Intervention | units on a scale (Mean) |
---|
Quetiapine XR | -0.5 |
Placebo | 3.9 |
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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
Intervention | units 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
Intervention | units 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
Intervention | units 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
Intervention | units 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
Intervention | units 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
Intervention | units 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
Intervention | units 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
Intervention | units 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
Intervention | units 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
Intervention | scores 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
Intervention | scores 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
Intervention | percentage of participants (Number) |
---|
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) | 87.6 |
Chlorpromazine | 88.9 |
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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
Intervention | Percentage of participants (Number) |
---|
Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) | 57.7 |
Chlorpromazine | 66.3 |
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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
Intervention | scores 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
Intervention | scores 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
Intervention | scores 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
Intervention | scores 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
Intervention | scores 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
Intervention | scores on a scale (Mean) |
---|
Quetiapine XR | 2.3 |
Quatiapine XR + Lithium | 2.2 |
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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
Intervention | Scores on a scale (Mean) |
---|
Quetiapine XR | 3.7 |
Quatiapine XR + Lithium | 5.0 |
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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
Intervention | scores on a scale (Mean) |
---|
Quetiapine XR | 3.1 |
Quatiapine XR + Lithium | 3.3 |
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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
Intervention | percentage of participants (Number) |
---|
Quetiapine XR | 93.2 |
Quatiapine XR + Lithium | 92.9 |
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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
Intervention | Scores on a scale (Mean) |
---|
| Effectivenes, baseline | Effectivenes, week 8 | Side effects, baseline | Side effects, week 8 | Convenience, baseline | Convenience, week 8 | Global satisfaction, baseline | Global satisfaction, week 8 |
---|
Quatiapine XR + Lithium | 36.7 | 66.7 | 44.4 | 50.4 | 52.8 | 72.9 | 35.0 | 70.7 |
,Quetiapine XR | 42.7 | 68.7 | 41.7 | 58.2 | 53.8 | 73.6 | 37.4 | 69.4 |
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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
Intervention | scores on a scale (Mean) |
---|
Quetiapine XR | 17.5 |
Quatiapine XR + Lithium | 17.7 |
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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
Intervention | scores on a scale (Mean) |
---|
Quetiapine XR | 23.7 |
Quatiapine XR + Lithium | 24.3 |
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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
Intervention | scores 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
Intervention | scores on a scale (Mean) |
---|
Quetiapine XR | 20.5 |
Quatiapine XR + Lithium | 21.0 |
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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
Intervention | scores on a scale (Mean) |
---|
Quetiapine XR | 14.4 |
Quatiapine XR + Lithium | 14.3 |
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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)
Intervention | mm * hour (Least Squares Mean) |
---|
Quetiapine IR | 1061.12 |
Quetiapine XR | 988.842 |
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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
Intervention | units 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
Intervention | units 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
Intervention | units on scale (Mean) |
---|
Quetiapine IR | -0.1 |
Quetiapine XR | 0.1 |
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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)
Intervention | units on scale (Least Squares Mean) |
---|
Quetiapine IR | 99.929 |
Quetiapine XR | 96.937 |
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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)
Intervention | units on scale (Least Squares Mean) |
---|
Quetiapine IR | 51.521 |
Quetiapine XR | 29.146 |
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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)
Intervention | units on scale (Least Squares Mean) |
---|
Quetiapine IR | 48.336 |
Quetiapine XR | 30.130 |
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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)
Intervention | units on scale (Least Squares Mean) |
---|
Quetiapine IR | 49.414 |
Quetiapine XR | 32.626 |
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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)
Intervention | units on scale (Least Squares Mean) |
---|
Quetiapine IR | 48.959 |
Quetiapine XR | 30.144 |
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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)
Intervention | units on scale (Least Squares Mean) |
---|
Quetiapine IR | 45.022 |
Quetiapine XR | 32.472 |
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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
Intervention | Patients (Number) |
---|
Quetiapine IR | 8 |
Quetiapine XR | 2 |
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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
Intervention | Patients (Number) |
---|
Quetiapine IR | 11 |
Quetiapine XR | 12 |
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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)
Intervention | Hours (Least Squares Mean) |
---|
Quetiapine IR | 3.685 |
Quetiapine XR | 4.254 |
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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
Intervention | Scores 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.
Intervention | Scores 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
Intervention | Scores 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
Intervention | Scores 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
Intervention | Scores 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.
Intervention | Scores 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.
Intervention | Participants (Number) |
---|
Lithium+Quetiapine XR | 134 |
Placebo+Quetiapine XR | 125 |
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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
Intervention | Participants (Number) |
---|
Lithium+Quetiapine XR | 125 |
Placebo+Quetiapine XR | 105 |
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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)
Intervention | Participants (Number) |
---|
Lithium+Quetiapine XR | 137 |
Placebo+Quetiapine XR | 120 |
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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
Intervention | Scores 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
Intervention | Scores on a scale (Least Squares Mean) |
---|
Lithium+Quetiapine XR | 1.7 |
Placebo+Quetiapine XR | 1.9 |
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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.
Intervention | Scores 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
Intervention | Scores 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
Intervention | Scores 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
Intervention | Scores 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
Intervention | Scores 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
Intervention | Scores 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
Intervention | Scores 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
Intervention | Scores 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
Intervention | Scores 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
Intervention | Scores 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
Intervention | units on a scale (Median) |
---|
Intervention Cohort Baseline | 22.00 |
Intervention Cohort End of Treatment | 6.00 |
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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
Intervention | units on a scale (Median) |
---|
Intervention Cohort Baseline | 26.50 |
Intervention Cohort End of Treatment | 6.50 |
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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
Intervention | units on a scale (Median) |
---|
Intervention Cohort Baseline | 15.00 |
Intervention Cohort End of Treatment | 3.00 |
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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
Intervention | units on a scale (Median) |
---|
Intervention Cohort Baseline | 24.00 |
Intervention Cohort End of Treatment | 5.50 |
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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
Intervention | units on a scale (Median) |
---|
Intervention Cohort Baseline | 25.00 |
Intervention Cohort End of Treatment | 6.00 |
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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
Intervention | units on a scale (Median) |
---|
Intervention Cohort Baseline | 50.00 |
Intervention Cohort End of Treatment | 35.00 |
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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
Intervention | mg/L (Median) |
---|
Experimental Cohort | 3.31 |
Healthy Control | 0.50 |
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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
Intervention | Scores 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
Intervention | scores 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
Intervention | Scores 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
Intervention | Scores on a scale (Mean) |
---|
| Baseline | Day 21 |
---|
Quetiapine Fumarate XR | 3.9 | 2.4 |
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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
Intervention | Scores 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
Intervention | Scores 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
Intervention | Scores 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
Intervention | milligrams (Mean) |
---|
Open-Label Quetiapine Treatment | 197 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | Week 8 |
---|
Quetiapine | 95.8 | 104.6 |
,Quetiapine With SSRI | 85.4 | 86.1 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | Last visit |
---|
Quetiapine | 56.09 | 34.25 |
,Quetiapine With SSRI | 60.45 | 32.83 |
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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
Intervention | mg/dl (Mean) |
---|
| Baseline | Week 8 |
---|
Quetiapine | 109 | 121.1 |
,Quetiapine With SSRI | 94.6 | 123.3 |
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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
Intervention | mg/dl (Mean) |
---|
| Baseline | Week 8 |
---|
Quetiapine | 47.7 | 40.8 |
,Quetiapine With SSRI | 45.3 | 40.5 |
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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
Intervention | mg/dl (Mean) |
---|
| Baseline | Week 8 |
---|
Quetiapine | 144.9 | 170.6 |
,Quetiapine With SSRI | 154.25 | 190.5 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | Week 8 |
---|
Quetiapine | 80.4 | 87.9 |
,Quetiapine With SSRI | 77.6 | 91.1 |
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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
Intervention | ml/dl (Mean) |
---|
| Baseline | Week 8 |
---|
Quetiapine | 91.6 | 89.1 |
,Quetiapine and SSRI | 89.4 | 96.8 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | Last visit |
---|
Quetiapine | 27 | 9.57 |
,Quetiapine With SSRI | 26.73 | 10.14 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | Last visit |
---|
Quetiapine | 30.8 | 23.56 |
,Quetiapine With SSRI | 29.3 | 21.00 |
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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
Intervention | mg/dl (Mean) |
---|
| Baseline | Week 8 |
---|
Quetiapine | 184.2 | 188 |
,Quetiapine With SSRI | 171.8 | 201.7 |
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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) |
---|
| Baseline | Week 8 |
---|
Quetiapine | 5.6 | 5.4 |
,Quetiapine With SSRI | 5.7 | 5.8 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | Last visit |
---|
Quetiapine | 77.38 | 77.25 |
,Quetiapine With SSRI | 70.00 | 78.29 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | Week 8 |
---|
Quetiapine | 70.6 | 70.5 |
,Quetiapine With SSRI | 75.6 | 78.3 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | Week 8 |
---|
Quetiapine | 82.4 | 72.9 |
,Quetiapine With SSRI | 69.6 | 74.7 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline 17-item HDRS | Post-treatment at 8 weeks 17-item HDRS |
---|
Quetiapine | 20 | 8 |
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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 XR | 0 |
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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
Intervention | units on a scale (Mean) |
---|
Seroquel | 7.3 |
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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
Intervention | Participants (Count of Participants) |
---|
IPSRT Plus Quetiapine | 16 |
Placebo | 13 |
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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
Intervention | Days (Median) |
---|
Paliperidone Palmitate | NA |
Oral Antipsychotics | NA |
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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
Intervention | Units 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
Intervention | percentage of participants (Number) |
---|
| Treatment Failure Due to Any Event | Arrest/incarceration | Psychiatric hospitalization | D/C due to safety/tolerability | Treatment supplementation | D/C due to inadequate efficacy | Increase in level of psychiatric services | Suicide |
---|
Oral Antipsychotics | 53.7 | 29.4 | 11.9 | 3.7 | 2.8 | 4.1 | 1.8 | 0 |
,Paliperidone Palmitate | 39.8 | 21.2 | 8.0 | 6.6 | 2.2 | 0.4 | 1.3 | 0 |
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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
Intervention | Days (Median) |
---|
Paliperidone Palmitate | NA |
Oral Antipsychotics | 274 |
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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
Intervention | Days (Median) |
---|
Paliperidone Palmitate | 416 |
Oral Antipsychotics | 226 |
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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
Intervention | days (Mean) |
---|
Quetiapine Fumarate Extended Release (Quetiapine XR) | 2.1 |
Quetiapine XR Plus Mirtazapine | 1.3 |
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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
Intervention | participants (Number) |
---|
| MADRS | YMRS |
---|
Active Quetiapine S.R., 200-600mg, po, qd | 4 | 4 |
,Placebo Quetiapine S.R. 200-600mg, po, qd | 4 | 4 |
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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
Intervention | units on a scale (Mean) |
---|
| Side Effects | Effectiveness | Convenience | Overall Satisfaction |
---|
Seroquel IR | 81.5 | 62.2 | 63.6 | 58.9 |
,Seroquel XR | 87.9 | 65.4 | 66.2 | 63.0 |
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Number of Dropouts.
The number of patients who dropped out was counted. (NCT01213836)
Timeframe: Period 1 and Period 2
Intervention | participants (Number) |
---|
| Period 1 | Period 2 |
---|
Seroquel IR | 2 | 0 |
,Seroquel XR | 3 | 0 |
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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.
Intervention | standardised units (Mean) |
---|
| Post 1 | Post 2 | Post 3 |
---|
Seroquel IR | -0.098 | -0.131 | -0.120 |
,Seroquel XR | 0.002 | -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.
Intervention | units on a scale (Mean) |
---|
Seroquel XR | 23.5 |
Seroquel IR | 28.6 |
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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.
Intervention | units on a scale (Mean) |
---|
Seroquel XR | 2.4 |
Seroquel IR | 2.6 |
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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
Intervention | Ratio (Mean) |
---|
Seroquel XR | 1.941 |
Seroquel IR | 2.128 |
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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
Intervention | units 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
Intervention | scores 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
Intervention | scores 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
Intervention | Participants (Number) |
---|
Placebo | 65 |
Quetiapine XR | 91 |
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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
Intervention | Participants (Number) |
---|
Placebo | 4 |
Quetiapine XR | 1 |
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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
Intervention | Participants (Number) |
---|
Placebo | 59 |
Quetiapine XR | 88 |
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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
Intervention | Participants (Number) |
---|
Placebo | 62 |
Quetiapine XR | 93 |
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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
Intervention | Scores on a scale (Least Squares Mean) |
---|
| Change from Baseline to End of Study | Baseline |
---|
Placebo | -15.27 | 28.8 |
,Quetiapine XR | -18.48 | 28.5 |
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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
Intervention | Scores on a scale (Least Squares Mean) |
---|
| CGI-BP-S score for Overall Bipolar (BP) Illness | CGI-BP-S score of depression | CGI-BP-S overall score Baseline | CGI-BP-S score for depression Baseline |
---|
Placebo | -1.73 | -1.81 | 4.5 | 4.5 |
,Quetiapine XR | -2.24 | -2.28 | 4.6 | 4.6 |
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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
Intervention | Scores on a scale (Least Squares Mean) |
---|
| Change from Baseline to Week 8 | Baseline |
---|
Placebo | -12.92 | 23.2 |
,Quetiapine XR | -15.16 | 23.5 |
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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
Intervention | Scores on a scale (Least Squares Mean) |
---|
| Change from Baseline to Week 8 | Baseline |
---|
Placebo | -0.76 | 1.2 |
,Quetiapine XR | -0.98 | 1.0 |
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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
Intervention | Scores on a scale (Least Squares Mean) |
---|
| Change from Baseline to Week 1 | Change from Baseline to Week 2 | Change from Baseline to Week 4 | Change from Baseline to Week 6 | Change from Baseline to Week 8 | Baseline |
---|
Placebo | -4.14 | -7.70 | -11.05 | -13.96 | -15.27 | 28.8 |
,Quetiapine XR | -5.62 | -10.13 | -14.18 | -16.04 | -18.48 | 28.5 |
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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
Intervention | Mean NCAs per month (Mean) |
---|
Li + APT | .8 |
QTP + APT | .9 |
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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
Intervention | Units on the scale (Mean) |
---|
Li + APT | 1.58 |
QTP + APT | 1.52 |
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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
Intervention | units on a scale (Mean) |
---|
Li + APT | -0.26 |
QTP + APT | 0.17 |
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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
Intervention | days (Mean) |
---|
Lithium | 41 |
Quetiapine | 77 |
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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
Intervention | IR Score (Mean) |
---|
Lithium | -5.5 |
Quetiapine | 0.2 |
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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
Intervention | percentage of subjects (Number) |
---|
| Single never married | Married | Disrupted Marriage |
---|
Divalproex | 27.1 | 55.9 | 17.0 |
,Lithium | 33.3 | 37.0 | 29.6 |
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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
Intervention | percentage of participants (Number) |
---|
Bipolar Type 1 Divalproex Group | 70 |
Bipolar Type II Divalproex Group | 74.1 |
Bipolar Type 1 Lithium Group | 30 |
Bipolar Type II Lithium Group | 25.9 |
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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
Intervention | calculated mean scale score (Mean) |
---|
| Mania | Depression | Irritability | Anxiety | Psychosis |
---|
Divalproex After Randomization 1 | -0.31 | -0.71 | -0.50 | -0.49 | -0.14 |
,Divalproex or Lithium Monotherapy | 0.15 | -0.18 | -0.27 | 0.16 | -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
Intervention | calculated mean scale score (Mean) |
---|
| CGI-Depression | CGI-Mania | CGI-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
Intervention | units on a scale (Mean) |
---|
| change at week 4 | change at week 8 |
---|
Trazodone | -14 | -16 |
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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
Intervention | units on a scale (Mean) |
---|
| change at 4 weeks | change 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
Intervention | percentage of heavy drinking days (Mean) |
---|
| percentage at week 4 | percentage at week 8 |
---|
Trazodone | 0 | 0 |
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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
Intervention | percentage of tests (Mean) |
---|
| cumulative percentage at week 4 | cumulative percentage at week 8 |
---|
Trazodone | 0 | 0 |
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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
Intervention | units on a scale (Mean) |
---|
| change after week 4 | change 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
Intervention | units on a scale (Mean) |
---|
| change at week 4 | change 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
Intervention | units on a scale (Mean) |
---|
| change at week 4 | change 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
Intervention | units on a scale (Mean) |
---|
| change at week 4 | change 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
Intervention | dollars (Median) |
---|
| week 1 | week 2 | week 3 | week 4 | week 5 | week 6 | week 7 | week 8 | week 9 | week 10 | week 11 | week 12 |
---|
Placebo | 14.00 | 10.00 | 7.14 | 6.43 | 6.43 | 5.71 | 3.70 | 2.86 | 6.43 | 5.35 | 3.21 | 1.00 |
,Quetiapine | 7.00 | 8.00 | 5.86 | 5.71 | 4.29 | 4.11 | 3.57 | 3.43 | 3.00 | 2.86 | 2.86 | 2.14 |
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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
Intervention | Participants (Count of Participants) |
---|
| Week 172079520 | Week 172079519 | Week 272079519 | Week 272079520 | Week 372079519 | Week 372079520 | Week 472079519 | Week 472079520 | Week 572079520 | Week 572079519 | Week 672079520 | Week 672079519 | Week 772079519 | Week 772079520 | Week 872079519 | Week 872079520 | Week 972079519 | Week 972079520 | Week 1072079520 | Week 1072079519 | Week 1172079519 | Week 1172079520 | Week 1272079519 | Week 1272079520 |
---|
| high use | medium use | low use |
---|
Quetiapine | 4 |
Placebo | 9 |
Quetiapine | 9 |
Placebo | 40 |
Quetiapine | 46 |
Placebo | 8 |
Placebo | 7 |
Quetiapine | 7 |
Placebo | 34 |
Quetiapine | 44 |
Quetiapine | 5 |
Placebo | 28 |
Quetiapine | 33 |
Quetiapine | 8 |
Placebo | 23 |
Quetiapine | 26 |
Placebo | 10 |
Quetiapine | 10 |
Quetiapine | 16 |
Placebo | 22 |
Quetiapine | 21 |
Placebo | 13 |
Placebo | 4 |
Quetiapine | 13 |
Quetiapine | 23 |
Placebo | 12 |
Quetiapine | 11 |
Quetiapine | 15 |
Quetiapine | 17 |
Placebo | 18 |
Placebo | 14 |
Placebo | 15 |
Quetiapine | 14 |
Placebo | 5 |
Quetiapine | 12 |
Placebo | 16 |
Placebo | 17 |
Placebo | 3 |
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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
Intervention | units 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
Intervention | percentage of participants (Number) |
---|
Placebo | 54.5 |
Quetiapine 50 mg | 50.0 |
Quetiapine 150 mg | 53.7 |
Quetiapine 300 mg | 27.2 |
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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
Intervention | participants (Number) |
---|
| Any adverse event | Drug-related adverse event | Deaths | Serious adverse event | Drug-related serious adverse event | AE leading to discontinuation | Drug-related AE leading to discontinuation |
---|
Placebo | 25 | 21 | 0 | 0 | 0 | 2 | 1 |
,Quetiapine 150 mg | 35 | 29 | 0 | 0 | 0 | 6 | 6 |
,Quetiapine 300 mg | 35 | 31 | 0 | 1 | 1 | 4 | 2 |
,Quetiapine 50 mg | 33 | 24 | 0 | 1 | 1 | 2 | 2 |
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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
Intervention | units 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
Intervention | units 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)
Intervention | Participants (Count of Participants) |
---|
| Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined treatment period |
---|
Placebo / FK949E | 17 | 9 | 6 | 5 | 4 | 6 | 2 | 3 | 3 | 3 | 1 | 6 |
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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
Intervention | units on a scale (Mean) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 8 | End 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
Intervention | units on a scale (Mean) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 8 | Week 10 | Week 12 | Week 13 | Week 14 | Week 16 | Week 18 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End 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
Intervention | units on a scale (Mean) |
---|
| Week 13 | Week 14 | Week 16 | Week 18 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End 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
Intervention | units on a scale (Mean) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 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
Intervention | units on a scale (Mean) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 8 | Week 10 | Week 12 | Week 13 | Week 14 | Week 16 | Week 18 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End 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
Intervention | units on a scale (Mean) |
---|
| Week 13 | Week 14 | Week 16 | Week 18 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End 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
Intervention | units on a scale (Mean) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 8 |
---|
FK949E 150 mg | 4.0 | 4.0 | 4.0 | 4.0 | 3.9 | 3.9 |
,FK949E 300 mg | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 |
,Placebo | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 |
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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
Intervention | units on a scale (Mean) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 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
Intervention | units on a scale (Mean) |
---|
| Week 14 | Week 16 | Week 20 | Week 28 | Week 36 | Week 44 | Week 52 | End 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
Intervention | units on a scale (Mean) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 8 | Week 10 | Week 12 | Week 14 | Week 16 | Week 20 | Week 28 | Week 36 | Week 44 | Week 52 | End 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
Intervention | units on a scale (Mean) |
---|
| Week 4 | Week 8 | End of Treatment Period I |
---|
FK949E 150 mg | 0.0 | 0.0 | 0.0 |
,Placebo | 0.0 | 0.1 | 0.1 |
,Treatment Period I: FK949E 300 mg | 0.2 | 0.1 | 0.1 |
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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
Intervention | units on a scale (Mean) |
---|
| Week 16 | Week 20 | Week 28 | Week 36 | Week 44 | Week 52 | End of combined treatment period |
---|
Placebo / FK949E | 0.2 | 0.1 | 0.1 | 0.0 | 0.0 | 0.1 | 0.1 |
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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
Intervention | units on a scale (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 28 | Week 36 | Week 44 | Week 52 | End of combined treatment period |
---|
FK949E 150 mg / FK949E | 0.0 | 0.0 | 0.1 | 0.1 | 0.1 | -0.0 | 0.0 | -0.0 | 0.0 | -0.0 |
,FK949E 300 mg / FK949E | 0.2 | 0.1 | 0.1 | 0.1 | 0.1 | 0.0 | -0.1 | -0.1 | -0.2 | 0.0 |
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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
Intervention | units on a scale (Mean) |
---|
| Week 4 | Week 8 | End of Treatment Period I |
---|
FK949E 150 mg | -0.1 | -0.1 | -0.1 |
,FK949E 300 mg | 0.0 | -0.1 | -0.1 |
,Placebo | 0.0 | 0.0 | 0.1 |
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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
Intervention | umits on a scale (Mean) |
---|
| Week 16 | Week 20 | Week 28 | Week 36 | Week 44 | Week 52 | End of combined treatment period |
---|
Placebo / FK949E | 0.0 | 0.0 | -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
Intervention | umits on a scale (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 28 | Week 36 | Week 44 | Week 52 | End of combined treatment period |
---|
FK949E 150 mg / FK949E | -0.1 | -0.1 | 0.0 | -0.0 | -0.0 | -0.1 | -0.1 | -0.1 | -0.1 | -0.1 |
,FK949E 300 mg / FK949E | 0.0 | -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
Intervention | units on a scale (Mean) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 8 |
---|
FK949E 150 mg | 0.0 | -0.0 | -0.0 | -0.0 | -0.1 | -0.1 |
,FK949E 300 mg | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
,Placebo | -0.0 | -0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined treatment period |
---|
Placebo / FK949E | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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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
Intervention | units on a scale (Mean) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 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
Intervention | units on a scale (Mean) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 8 | Week 10 | Week 12 | Week 14 | Week 16 | Week 18 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End 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
Intervention | units on a scale (Mean) |
---|
| Week 14 | Week 16 | Week 18 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End 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
Intervention | units on a scale (Mean) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 8 | Week 10 | Week 12 | Week 14 | Week 16 | Week 18 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined treatment period |
---|
FK949E 150 mg / FK949E | 0.0 | 0.0 | -0.0 | 0.0 | -0.0 | -0.0 | -0.0 | 0.0 | -0.1 | -0.1 | -0.1 | -0.1 | -0.0 | -0.0 | 0.0 | -0.0 | 0.0 | -0.0 | -0.0 | -0.0 | -0.1 |
,FK949E 300 mg / 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 | 0.0 | 0.0 | -0.0 | 0.0 | -0.0 | 0.0 | -0.0 | 0.1 |
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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
Intervention | units on a scale (Mean) |
---|
| Week 14 | Week 16 | Week 18 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End 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
Intervention | Participants (Count of Participants) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 8 |
---|
FK949E 150 mg | 6 | 17 | 25 | 28 | 34 | 32 |
,FK949E 300 mg | 15 | 41 | 52 | 62 | 70 | 79 |
,Placebo | 4 | 13 | 36 | 47 | 54 | 63 |
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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
Intervention | Participants (Count of Participants) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 8 | Week 10 | Week 12 | Week 13 | Week 14 | Week 16 | Week 18 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined treatment period |
---|
FK949E 300 mg / FK949E | 15 | 37 | 49 | 58 | 66 | 73 | 71 | 68 | 65 | 66 | 67 | 78 | 73 | 74 | 71 | 65 | 61 | 62 | 61 | 57 | 57 | 89 |
,FK949E 150 mg / FK949E | 6 | 16 | 23 | 25 | 30 | 27 | 28 | 22 | 32 | 30 | 26 | 30 | 30 | 31 | 34 | 31 | 30 | 28 | 28 | 29 | 27 | 42 |
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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
Intervention | Participants (Count of Participants) |
---|
| Week 13 | Week 14 | Week 16 | Week 18 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined treatment period |
---|
Placebo / FK949E | 8 | 26 | 31 | 48 | 47 | 48 | 48 | 43 | 43 | 47 | 42 | 38 | 41 | 57 |
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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
Intervention | Participants (Count of Participants) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 8 |
---|
FK949E 150 mg | 4 | 12 | 21 | 21 | 27 | 28 |
,FK949E 300 mg | 12 | 28 | 39 | 49 | 60 | 68 |
,Placebo | 4 | 9 | 26 | 31 | 39 | 47 |
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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
Intervention | Participants (Count of Participants) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 8 | Week 10 | Week 12 | Week 13 | Week 14 | Week 16 | Week 18 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined treatment period |
---|
FK949E 150 mg / FK949E | 4 | 11 | 20 | 19 | 24 | 25 | 24 | 20 | 24 | 24 | 20 | 23 | 24 | 28 | 28 | 28 | 27 | 26 | 24 | 24 | 26 | 38 |
,FK949E 300 mg / FK949E | 12 | 25 | 36 | 45 | 56 | 61 | 61 | 58 | 58 | 60 | 60 | 68 | 64 | 65 | 64 | 58 | 53 | 55 | 54 | 51 | 51 | 82 |
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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
Intervention | Participants (Count of Participants) |
---|
| Week 12 | Week 13 | Week 14 | Week 16 | Week 18 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined treatment period |
---|
Placebo / FK949E | 41 | 48 | 51 | 52 | 69 | 64 | 67 | 62 | 55 | 56 | 60 | 54 | 55 | 54 | 75 |
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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
Intervention | Participants (Count of Participants) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 8 |
---|
FK949E 150 mg | 7 | 22 | 30 | 35 | 44 | 41 |
,FK949E 300 mg | 14 | 42 | 52 | 64 | 66 | 78 |
,Placebo | 10 | 29 | 41 | 54 | 63 | 68 |
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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
Intervention | Participants (Count of Participants) |
---|
| Week 14 | Week 16 | Week 20 | Week 28 | Week 36 | Week 44 | Week 52 | End of combined treatment period |
---|
Placebo / FK949E | 20 | 30 | 40 | 44 | 36 | 41 | 40 | 53 |
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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
Intervention | Participants (Count of Participants) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 8 | Week 10 | Week 12 | Week 14 | Week 16 | Week 20 | Week 28 | Week 36 | Week 44 | Week 52 | End of combined treatment period |
---|
FK949E 150 mg / FK949E | 7 | 22 | 27 | 32 | 39 | 35 | 35 | 32 | 35 | 30 | 32 | 32 | 29 | 25 | 25 | 43 |
,FK949E 300 mg / FK949E | 14 | 39 | 50 | 61 | 63 | 73 | 77 | 77 | 78 | 80 | 75 | 73 | 61 | 61 | 58 | 95 |
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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
Intervention | participants (Number) |
---|
| Week 4: Wish to be dead | Week 4: Suicidal thoughts | Week 4: Suicidal thoughts w/ method | Week 4: Suicidal intent (w/o plan) | Week 4: Suicidal intent w/ plan | Week 8: Wish to be dead | Week 8: Suicidal thoughts | Week 8: Suicidal thoughts w/ method | Week 8: Suicidal intent (w/o plan) | Week 8: Suicidal intent w/ plan | End of Period I: Wish to be dead | End of Period I: Suicidal thoughts | Endf of Period I: Suicidal thoughts w/ method | End of Period I: Suicidal intent (w/o plan) | End of Period I: Suicidal intent w/ plan |
---|
FK949E 150 mg | 14 | 3 | 0 | 0 | 0 | 6 | 2 | 0 | 0 | 0 | 8 | 3 | 0 | 0 | 0 |
,FK949E 300 mg | 34 | 10 | 5 | 1 | 0 | 15 | 2 | 0 | 0 | 0 | 26 | 9 | 7 | 1 | 0 |
,Placebo | 39 | 10 | 4 | 1 | 1 | 19 | 6 | 3 | 0 | 0 | 32 | 13 | 7 | 2 | 1 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined treatment period |
---|
FK949E 150 mg / FK949E | 14 | 6 | 9 | 8 | 8 | 5 | 4 | 4 | 4 | 4 | 3 | 4 | 4 | 11 |
,FK949E 300 mg / FK949E | 34 | 15 | 21 | 22 | 12 | 8 | 8 | 9 | 8 | 6 | 7 | 7 | 3 | 26 |
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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
Intervention | units 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
Intervention | units on a scale (Mean) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 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)
Intervention | Participants (Count of Participants) |
---|
| Week 12 | Week 16 | Week 32 | End of combined treatment period |
---|
Placebo / FK949E | 1 | 1 | 1 | 2 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 36 | Week 40 | Week 48 | Week 52 | End of combined treatment period |
---|
FK949E 150 mg / FK949E | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 1 | 4 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 24 | Week 28 | Week 36 | Week 40 | Week 44 | Week 48 | End of combined treatment period |
---|
FK949E 300 mg / FK949E | 5 | 0 | 0 | 4 | 2 | 0 | 2 | 0 | 0 | 0 | 12 |
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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)
Intervention | particpants (Number) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined treatment period |
---|
FK949E 150 mg / FK949E | 3 | 2 | 2 | 2 | 2 | 1 | 1 | 0 | 1 | 2 | 0 | 1 | 1 | 2 |
,FK949E 300 mg / FK949E | 10 | 2 | 1 | 5 | 0 | 2 | 2 | 0 | 2 | 1 | 2 | 2 | 0 | 14 |
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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)
Intervention | particpants (Number) |
---|
| Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined treatment period |
---|
Placebo / FK949E | 4 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Week 12 | Week 16 | Week 32 | End of combined treatment period |
---|
Placebo / FK949E | 0 | 1 | 1 | 2 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 36 | Week 40 | Week 48 | Week 52 | End of combined treatment period |
---|
FK949E 150 mg / FK949E | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 24 | Week 28 | Week 36 | Week 40 | Week 44 | Week 48 | End of combined treatment period |
---|
FK949E 300 mg / FK949E | 1 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 4 |
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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
Intervention | units on a sale (Mean) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 8 | Week 10 | Week 12 | Week 14 | Week 16 | Week 18 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End 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
Intervention | units on a sale (Mean) |
---|
| Week 14 | Week 16 | Week 18 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End 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)
Intervention | units on a scale (Mean) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 8 | Week 10 | Week 12 | Week 14 | Week 16 | Week 18 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined treatment period |
---|
FK949E 150 mg / FK949E | 3.5 | 3.1 | 2.9 | 2.7 | 2.6 | 2.5 | 2.5 | 2.6 | 2.6 | 2.4 | 2.5 | 2.3 | 2.1 | 1.9 | 2.1 | 1.9 | 1.8 | 2.0 | 1.9 | 1.7 | 2.5 |
,FK949E 300 mg / FK949E | 3.5 | 3.2 | 2.9 | 2.7 | 2.7 | 2.5 | 2.4 | 2.4 | 2.4 | 2.4 | 2.2 | 2.3 | 2.2 | 2.2 | 2.2 | 2.1 | 2.1 | 1.9 | 2.0 | 1.8 | 2.7 |
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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)
Intervention | units on a scale (Mean) |
---|
| Week 12 | Week 14 | Week 16 | Week 18 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined treatment period |
---|
Placebo / FK949E | 2.7 | 2.4 | 2.3 | 2.1 | 2.0 | 1.9 | 1.9 | 2.0 | 1.9 | 1.8 | 1.8 | 1.9 | 1.8 | 2.1 |
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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)
Intervention | units on a scale (Mean) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 8 | Week 10 | Week 12 | Week 14 | Week 16 | Week 18 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined treatment period |
---|
FK949E 150 mg / FK949E | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 3.9 |
,FK949E 300 mg / FK949E | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 4.1 |
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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)
Intervention | units on a scale (Mean) |
---|
| Week 12 | Week 14 | Week 16 | Week 18 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined treatment period |
---|
Placebo / FK949E | 4.0 | 3.9 | 3.9 | 3.9 | 3.9 | 4.0 | 3.9 | 4.0 | 4.0 | 4.0 | 4.0 | 4.0 | 3.9 | 4.0 |
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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
Intervention | units on a scale (Mean) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 8 |
---|
FK949E 150 mg | 3.5 | 3.1 | 2.9 | 2.8 | 2.7 | 2.6 |
,FK949E 300 mg | 3.5 | 3.2 | 3.0 | 2.9 | 2.8 | 2.8 |
,Placebo | 3.7 | 3.6 | 3.4 | 3.2 | 3.2 | 3.1 |
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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)
Intervention | units on a scale (Mean) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 8 | Week 10 | Week 12 | Week 14 | Week 16 | Week 18 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined period |
---|
FK949E 150 mg / FK949E | 3.5 | 3.1 | 2.9 | 2.7 | 2.6 | 2.5 | 2.5 | 2.6 | 2.6 | 2.4 | 2.5 | 2.3 | 2.1 | 1.9 | 2.0 | 1.8 | 1.8 | 2.0 | 1.9 | 1.7 | 2.5 |
,FK949E 300 mg / FK949E | 3.5 | 3.1 | 2.9 | 2.7 | 2.7 | 2.5 | 2.4 | 2.4 | 2.4 | 2.4 | 2.2 | 2.2 | 2.2 | 2.2 | 2.1 | 2.1 | 2.1 | 1.9 | 1.9 | 1.8 | 2.6 |
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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)
Intervention | units on a scale (Mean) |
---|
| Week 12 | Week 14 | Week 16 | Week 18 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined period |
---|
Placebo / FK949E | 2.7 | 2.4 | 2.3 | 2.1 | 2.0 | 1.9 | 1.9 | 1.9 | 1.9 | 1.8 | 1.8 | 1.9 | 1.8 | 2.0 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Week 12 | Week 16 | Week 32 | End of combined treatment period |
---|
Placebo / FK949E | 0 | 1 | 1 | 2 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 36 | Week 40 | Week 48 | Week 52 | End of combined treatment period |
---|
FK949E 150 mg / FK949E | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 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)
Intervention | Participants (Count of Participants) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 24 | Week 28 | Week 36 | Week 40 | Week 44 | Week 48 | End of combined treatment period |
---|
FK949E 300 mg / FK949E | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
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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
Intervention | participants (Number) |
---|
| Week 4: Suicide attempt | Week 4: Self-injury w/o intent | Week 4: Discontinued attempt | Week 4: Interrupted attempt | Week 4: Preliminary act to suicide | Week 4: Suicidal behavior | Week 4: Completed suicide | Week 8: Suicide attempt | Week 8: Self-injury w/o intent | Week 8: Discontinued attempt | Week 8: Interrupted attempt | Week 8: Preliminary act to suicide | Week 8: Suicidal behavior | Week 8: Completed suicide | End of Period I: Suicide attempt | End of Period I: Self-injury w/o intent | End of Period I: Discontinued attempt | End of Period I: Interrupted attempt | End of Period I: Preliminary act to suicide | End of Period I: Suicidal behavior | End of Period I: Completed suicide |
---|
FK949E 150 mg | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,FK949E 300 mg | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 |
,Placebo | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 2 | 0 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined treatment period |
---|
FK949E 150 mg / FK949E | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
,FK949E 300 mg / FK949E | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined treatment period |
---|
Placebo / FK949E | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined treatment period |
---|
FK949E 150 mg / FK949E | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 0 | 1 |
,FK949E 300 mg / FK949E | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined treatment period |
---|
Placebo / FK949E | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined treatment period |
---|
FK949E 150 mg / FK949E | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,FK949E 300 mg / FK949E | 2 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 1 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined treatment period |
---|
Placebo / FK949E | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 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)
Intervention | Participants (Count of Participants) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined treatment period |
---|
FK949E 150 mg / FK949E | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,FK949E 300 mg / FK949E | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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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
Intervention | units on a scale (Mean) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 6 | Week 8 |
---|
FK949E 150 mg | 3.5 | 3.1 | 2.9 | 2.8 | 2.7 | 2.6 |
,FK949E 300 mg | 3.5 | 3.2 | 3.0 | 2.9 | 2.9 | 2.8 |
,Placebo | 3.7 | 3.6 | 3.4 | 3.3 | 3.3 | 3.1 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined treatment period |
---|
FK949E 150 mg / FK949E | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,FK949E 300 mg / FK949E | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined treatment period |
---|
Placebo / FK949E | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | Endof combined treatment period |
---|
FK949E 150 mg / FK949E | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
,FK949E 300 mg / FK949E | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | Endof combined treatment period |
---|
Placebo / FK949E | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined treatment period |
---|
FK949E 150 mg / FK949E | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,FK949E 300 mg / FK949E | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 | Week 36 | Week 40 | Week 44 | Week 48 | Week 52 | End of combined treatment period |
---|
Placebo / FK949E | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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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
Intervention | participants (Number) |
---|
| Any AE | Drug-related AEs | Deaths | Serious AEs | Drug-related SAEs | AEs that caused study drug discontimuation | Drug-related AEs that caused study drug discont. |
---|
FK949E 150 mg | 55 | 50 | 0 | 1 | 0 | 6 | 5 |
,FK949E 300 mg | 149 | 133 | 0 | 0 | 0 | 27 | 23 |
,Placebo | 81 | 52 | 1 | 2 | 0 | 16 | 11 |
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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)
Intervention | Participants (Count of Participants) |
---|
| Any AE | Drug-related AEs | Deaths | Serious AEs | Drug-related SAEs | AEs that caused study drug discontimuation | Drug-related AEs that caused study drug discont |
---|
FK949E 150 mg / FK949E | 63 | 60 | 0 | 4 | 2 | 15 | 11 |
,FK949E 300 mg / FK949E | 171 | 159 | 0 | 5 | 2 | 51 | 39 |
,Placebo / FK949E | 110 | 100 | 0 | 1 | 0 | 15 | 13 |
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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).
Intervention | Participants (Count of Participants) |
---|
Brexpiprazole + ADT | 100 |
Seroquel XR + ADT | 48 |
Placebo + ADT | 79 |
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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).
Intervention | Participants (Count of Participants) |
---|
Brexpiprazole + ADT | 20 |
Seroquel XR + ADT | 8 |
Placebo + ADT | 14 |
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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).
Intervention | Units 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).
Intervention | Participants (Count of Participants) |
---|
Brexpiprazole + ADT | 13 |
Seroquel XR + ADT | 2 |
Placebo + ADT | 9 |
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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).
Intervention | units 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)
Intervention | units on a scale (Least Squares Mean) |
---|
| Phase B Week 2 | Phase 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).
Intervention | Mean score (Mean) |
---|
| CGI-Severity of Illness Scale | CGI-Improvement Scale Score |
---|
Brexpiprazole + ADT | 3.98 | 2.55 |
,Placebo + ADT | 4.02 | 2.74 |
,Seroquel XR + ADT | 4.07 | 2.71 |
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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.
Intervention | Participants (Count of Participants) |
---|
| Death | Serious TEAE | Discontinuation due to TEAE | Any TEAE |
---|
Brexpiprazole + ADT | 0 | 0 | 2 | 100 |
,Placebo + ADT | 0 | 1 | 1 | 107 |
,Seroquel XR + ADT | 0 | 1 | 4 | 58 |
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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).
Intervention | units on a scale (Least Squares Mean) |
---|
| Work/School Score | Social Life Score | Family 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)
Intervention | units 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)
Intervention | units on a scale (Mean) |
---|
FK949E Elderly Participants | 0 |
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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)
Intervention | units 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)
Intervention | units on a scale (Mean) |
---|
FK949E Elderly Participants | 4.0 |
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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)
Intervention | units on a scale (Mean) |
---|
FK949E Elderly Participant | 2.4 |
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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)
Intervention | units 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)
Intervention | Participants (Count of Participants) |
---|
| Any AE | Drug-related AEs | Deaths | Serious AEs | Drug-related SAEs | AEs that caused study drug discountinuation | Drug-related AEs that caused study drug discont. |
---|
FK949E Elderly Participants | 18 | 18 | 0 | 2 | 1 | 8 | 7 |
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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)
Intervention | units on a scale (Mean) |
---|
FK949E Elderly Participants | 2.4 |
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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)
Intervention | units 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
Intervention | units 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
Intervention | units 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
Intervention | units 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
Intervention | units 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
Intervention | units 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
Intervention | units 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
Intervention | units 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
Intervention | units 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
Intervention | units 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
Intervention | units on a scale (Mean) |
---|
Placebo | 3.0 |
Brexpiprazole | 2.7 |
Quetiapine Extended Release | 2.5 |
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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
Intervention | percentage of patients (Number) |
---|
Placebo | 14.91 |
Brexpiprazole | 6.67 |
Quetiapine Extended Release | 7.19 |
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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
Intervention | percentage of remitters (Number) |
---|
Placebo | 5.7 |
Brexpiprazole | 9.6 |
Quetiapine Extended Release | 14.4 |
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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
Intervention | percentage of responders (Number) |
---|
Placebo | 36.3 |
Brexpiprazole | 53.4 |
Quetiapine Extended Release | 64.4 |
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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
Intervention | percentage of responders (Number) |
---|
Placebo | 32.1 |
Brexpiprazole | 48.7 |
Quetiapine Extended Release | 62.7 |
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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
Intervention | units 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
Intervention | units 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
Intervention | percentage of aggressive patients (Number) |
---|
Placebo | 30.4 |
Brexpiprazole | 27.2 |
Quetiapine Extended Release | 22.2 |
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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
Intervention | units on a scale (Mean) |
---|
Placebo | 9.4 |
Brexpiprazole | 13.0 |
Quetiapine Extended Release | 15.3 |
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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
Intervention | units on a scale (final score) (Mean) |
---|
Ketamine and DCS Treatment | 1.6 |
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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
Intervention | units on a scale (final score) (Mean) |
---|
Ketamine and DCS Treatment | 10.8 |
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HAM-D Suicide Item
Ham-D suicide item: range 0-4, higher scores indicate worse symptoms (NCT01833897)
Timeframe: 8 weeks
Intervention | units on a scale (final) (Mean) |
---|
Ketamine and DCS Treatment | 0.3 |
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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
Intervention | units on a scale (final score) (Mean) |
---|
Ketamine and DCS Treatment | 6.4 |
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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
Intervention | units on a scale (final score) (Mean) |
---|
Ketamine and DCS Treatment | 9.5 |
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Weight Change
(NCT01844700)
Timeframe: baseline to week 12
Intervention | lbs (Mean) |
---|
| baseline | week 12 (n=1,2) |
---|
Aripiprazole, Quetiapine, Risperidone | 118.5 | 141 |
,Ziprasidone | 120.5 | 151 |
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BMI Percentile
(NCT01844700)
Timeframe: baseline to week 12
Intervention | BMI percentile (Mean) |
---|
| baseline | week 12 (n=1, n=2) |
---|
Aripiprazole, Quetiapine, Risperidone | 37.67 | 62.5 |
,Ziprasidone | 32 | 59 |
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BMI Z-scores
(NCT01844700)
Timeframe: baseline to week 12
Intervention | BMI z-score (Mean) |
---|
| baseline | week 12 (n=1, n=2) |
---|
Aripiprazole, Quetiapine, Risperidone | -0.37 | 0.38 |
,Ziprasidone | -0.51 | 0.22 |
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Percent Weight Change Compared to Baseline Weight
(NCT01844700)
Timeframe: baseline to week 12
Intervention | percentage of weight change (Mean) |
---|
Ziprasidone | 11.58 |
Aripiprazole, Quetiapine, Risperidone | 5.66 |
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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
Intervention | kg/m^2 (Mean) |
---|
Quitiapine Plus Omega | 24.4 |
Quetiapine Plus Placebo | 26.3 |
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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
Intervention | mg/dL (Mean) |
---|
Quitiapine Plus Omega | 99.7 |
Quetiapine Plus Placebo | 88 |
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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
Intervention | units on a scale (Mean) |
---|
Quitiapine Plus Omega | 4.3 |
Quetiapine Plus Placebo | 7.2 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | LOCF |
---|
Placebo Plus CBT | 16.6 | 14.1 |
,Seroquel XR Plus CBT | 15.1 | 1.8 |
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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
Intervention | units on a scale (Mean) |
---|
| CGI-S Baseline | CGI-S LOCF | CGI-I Baseline | CGI-I LOCF |
---|
Placebo Plus CBT | 4.3 | 2.9 | 2.7 | 2.4 |
,Seroquel XR Plus CBT | 4.1 | 2.5 | 3.3 | 1.8 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | LOCF (last observation carried forward) |
---|
Placebo Plus CBT | 17.8 | 9.4 |
,Seroquel XR Plus CBT | 16.7 | 5.9 |
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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
Intervention | units on a scale (Mean) |
---|
| Baseline | LOCF (last observation carried forward) |
---|
Placebo Plus CBT | 28.6 | 15.7 |
,Seroquel XR Plus CBT | 27.1 | 9.1 |
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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
Intervention | units on a scale (Median) |
---|
Quetiapine | 1 |
Placebo | 0 |
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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
Intervention | days (Mean) |
---|
Quetiapine | 8 |
Placebo | 7 |
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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
Intervention | days (Mean) |
---|
Quetiapine | 8 |
Placebo | 7 |
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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)
Intervention | UNITS ON A SCALE (Least Squares Mean) |
---|
FK949E 50 mg Tablets | 7.4 |
FK949E 150 mg Tablets | 7.9 |
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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)
Intervention | Units on a scale (Mean) |
---|
FK949E 50 mg Tablets | 4.0 |
FK949E 150 mg Tablets | 4.0 |
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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)
Intervention | Units on a scale (Least Squares Mean) |
---|
FK949E 50 mg Tablets | 2.0 |
FK949E 150 mg Tablets | 2.0 |
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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
Intervention | Participants (Number) |
---|
| Any AE | Drug-related AEs | Deaths | Serious AEs | Drug-related SAEs | AEs that caused study drug discontinuation | Drug-related AEs that caused study drug discont. |
---|
Treatment Period II FK949E 150 mg | 2 | 1 | 0 | 0 | 0 | 0 | 0 |
,Treatment Period II FK949E 50 mg | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
,Treatment Period III FK949E 150 mg | 5 | 2 | 0 | 0 | 0 | 0 | 0 |
,Treatment Period III FK949E 50 mg | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
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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)
Intervention | Units on a scale (Mean) |
---|
FK949E 50 mg Tablets | 1.0 |
FK949E 150 mg Tablets | 1.0 |
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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)
Intervention | Units on a scale (Least Squares Mean) |
---|
FK949E 50 mg Tablets | 2.1 |
FK949E 150 mg Tablets | 2.0 |
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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)
Intervention | Units on a scale (Least Squares Mean) |
---|
FK949E 50 mg Tablets | 5.5 |
FK949E 150 mg Tablets | 5.4 |
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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)
Intervention | Units on a scale (Least Squares Mean) |
---|
FK949E 50 mg Tablets | 2.0 |
FK949E 150 mg Tablets | 2.0 |
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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)
Intervention | Units on a scale (Least Squares Mean) |
---|
FK949E 50 mg Tablets | 2.1 |
FK949E 150 mg Tablets | 2.0 |
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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
Intervention | T-score (Mean) |
---|
Part 3-PP to PP | 3.4 |
Part 3-OAP to OAP | 4.7 |
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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
Intervention | units on a scale (Mean) |
---|
Part 3-PP to PP | 0.3 |
Part 3-OAP to OAP | 0.4 |
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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
Intervention | units 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
Intervention | T-score (Mean) |
---|
Part 3-PP to PP | 2.4 |
Part 3-OAP to OAP | 0.7 |
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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
Intervention | ratio (Mean) |
---|
Part 3-PP to PP | -0.001 |
Part 3-OAP to OAP | -0.003 |
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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
Intervention | T-score (Mean) |
---|
Part 3- PP to PP | -0.7 |
Part 3- OAP to PP (or Delayed-Start PP) | -0.2 |
Part 3-OAP to OAP | 0.5 |
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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
Intervention | T-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
Intervention | T-score (Mean) |
---|
Part-2: Paliperidone Palmitate (PP) | 1.3 |
Part-2: OAP | 1.4 |
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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
Intervention | T-score (Mean) |
---|
Part-2: Paliperidone Palmitate (PP) | 1.8 |
Part-2: OAP | 3.5 |
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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
Intervention | T-score (Mean) |
---|
Part-2: Paliperidone Palmitate (PP) | 0.3 |
Part-2: OAP | 1.6 |
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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
Intervention | T-score (Mean) |
---|
Part-2: Paliperidone Palmitate (PP) | 0.2 |
Part-2: OAP | 2.8 |
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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)
Intervention | units on a scale (Mean) |
---|
Part-2: Paliperidone Palmitate (PP) | -0.2 |
Part-2: OAP | 0.1 |
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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
Intervention | T-score (Least Squares Mean) |
---|
Part-2: Paliperidone Palmitate (PP) | 2.0 |
Part-2: OAP | 2.8 |
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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
Intervention | units 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
Intervention | T-score (Mean) |
---|
Part-2: Paliperidone Palmitate (PP) | 3.2 |
Part-2: OAP | 0.7 |
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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
Intervention | ratio (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
Intervention | days (Median) |
---|
Part 3-PP to PP | NA |
Part 3-OAP to OAP | NA |
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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
Intervention | Participants (Count of Participants) |
---|
| Hallucinations72513609 | Hallucinations72513610 | Delusions72513609 | Delusions72513610 | Disorganized Speech72513609 | Disorganized Speech72513610 | Abnormal Psychomotor Behavior72513609 | Abnormal Psychomotor Behavior72513610 | Negative Symptoms72513609 | Negative Symptoms72513610 | Impaired Cognition72513609 | Impaired Cognition72513610 | Mania72513609 | Mania72513610 | Depression72513609 | Depression72513610 |
---|
| Worsened | Unchanged | Improved |
---|
Part 3-PP to PP | 3 |
Part 3-OAP to OAP | 8 |
Part 3-PP to PP | 27 |
Part 3-OAP to OAP | 29 |
Part 3-PP to PP | 11 |
Part 3-OAP to OAP | 10 |
Part 3-PP to PP | 6 |
Part 3-PP to PP | 21 |
Part 3-OAP to OAP | 20 |
Part 3-PP to PP | 14 |
Part 3-OAP to OAP | 17 |
Part 3-PP to PP | 2 |
Part 3-OAP to OAP | 36 |
Part 3-PP to PP | 12 |
Part 3-PP to PP | 4 |
Part 3-OAP to OAP | 2 |
Part 3-PP to PP | 32 |
Part 3-OAP to OAP | 37 |
Part 3-PP to PP | 5 |
Part 3-OAP to OAP | 4 |
Part 3-OAP to OAP | 22 |
Part 3-PP to PP | 19 |
Part 3-OAP to OAP | 21 |
Part 3-PP to PP | 10 |
Part 3-OAP to OAP | 9 |
Part 3-OAP to OAP | 23 |
Part 3-PP to PP | 17 |
Part 3-OAP to OAP | 15 |
Part 3-PP to PP | 0 |
Part 3-OAP to OAP | 3 |
Part 3-PP to PP | 40 |
Part 3-OAP to OAP | 39 |
Part 3-PP to PP | 1 |
Part 3-OAP to OAP | 5 |
Part 3-PP to PP | 7 |
Part 3-OAP to OAP | 6 |
Part 3-PP to PP | 26 |
Part 3-PP to PP | 8 |
Part 3-OAP to OAP | 12 |
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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
Intervention | Participants (Count of Participants) |
---|
| Hallucinations72513608 | Hallucinations72513614 | Delusions72513614 | Delusions72513608 | Disorganized Speech72513614 | Disorganized Speech72513608 | Abnormal Psychomotor Behavior72513614 | Abnormal Psychomotor Behavior72513608 | Negative Symptoms72513608 | Negative Symptoms72513614 | Impaired Cognition72513614 | Impaired Cognition72513608 | Mania72513608 | Mania72513614 | Depression72513608 | Depression72513614 |
---|
| Unchanged | Improved | Worsened |
---|
Part-2: OAP | 19 |
Part-2: Paliperidone Palmitate (PP) | 29 |
Part-2: OAP | 73 |
Part-2: Paliperidone Palmitate (PP) | 14 |
Part-2: OAP | 33 |
Part-2: Paliperidone Palmitate (PP) | 10 |
Part-2: OAP | 20 |
Part-2: Paliperidone Palmitate (PP) | 23 |
Part-2: OAP | 70 |
Part-2: OAP | 35 |
Part-2: OAP | 13 |
Part-2: Paliperidone Palmitate (PP) | 36 |
Part-2: OAP | 85 |
Part-2: Paliperidone Palmitate (PP) | 12 |
Part-2: OAP | 27 |
Part-2: Paliperidone Palmitate (PP) | 9 |
Part-2: OAP | 14 |
Part-2: Paliperidone Palmitate (PP) | 37 |
Part-2: OAP | 86 |
Part-2: Paliperidone Palmitate (PP) | 4 |
Part-2: OAP | 25 |
Part-2: Paliperidone Palmitate (PP) | 16 |
Part-2: OAP | 61 |
Part-2: Paliperidone Palmitate (PP) | 17 |
Part-2: OAP | 39 |
Part-2: Paliperidone Palmitate (PP) | 13 |
Part-2: OAP | 29 |
Part-2: Paliperidone Palmitate (PP) | 22 |
Part-2: OAP | 52 |
Part-2: Paliperidone Palmitate (PP) | 15 |
Part-2: OAP | 44 |
Part-2: Paliperidone Palmitate (PP) | 1 |
Part-2: OAP | 7 |
Part-2: Paliperidone Palmitate (PP) | 47 |
Part-2: OAP | 107 |
Part-2: Paliperidone Palmitate (PP) | 2 |
Part-2: OAP | 11 |
Part-2: Paliperidone Palmitate (PP) | 7 |
Part-2: OAP | 28 |
Part-2: Paliperidone Palmitate (PP) | 33 |
Part-2: OAP | 74 |
Part-2: OAP | 23 |
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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
Intervention | days (Median) |
---|
Part-2: Paliperidone Palmitate (PP) | NA |
Part-2: OAP | NA |
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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
Intervention | T-score (Mean) |
---|
Part 3-PP to PP | 1.6 |
Part 3-OAP to OAP | 3.2 |
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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
Intervention | T-score (Mean) |
---|
Part-2: Paliperidone Palmitate (PP) | 1.3 |
Part-2: OAP | 1.0 |
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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
Intervention | T-score (Mean) |
---|
Part 3-PP to PP | -1.7 |
Part 3-OAP to OAP | 0.7 |
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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
Intervention | T-score (Mean) |
---|
Part 3-PP to PP | 0.2 |
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
Intervention | T-score (Mean) |
---|
Part 3-PP to PP | 0.3 |
Part 3-OAP to OAP | 0.8 |
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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
Intervention | T-score (Mean) |
---|
Part 3-PP to PP | 2.5 |
Part 3-OAP to OAP | 4.9 |
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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
Intervention | T-score (Mean) |
---|
Part 3-PP to PP | -0.2 |
Part 3-OAP to OAP | 1.4 |
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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
Intervention | ratio (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 OAP | 0.5 |
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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
Intervention | percent 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 1 | 100 | 100 | 100 | 100 | 100 | 100 | 97 | 93 | 90 | 90 | 96 | 90 | 95 | 100 | 100 | 100 | 100 |
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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
Intervention | Participants (Number) |
---|
Cohort 1 | 4 |
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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
Intervention | units 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 1 | 7 | 7 | 7 | 7 | 7 | 7 | 7 | 7 | 7 | 7 | 7 | 7 | 7 | 7 | 7 | 7 | 7 |
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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
Intervention | units 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 1 | 12 | 4 | 8 | 2 | 8 | 8 | 14 | 9 | 4 | 7 | 4 | 5 | 8 | 4 | 4 | 4 | 6 |
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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
Intervention | participants (Number) |
---|
| Side Effects Of Medication | Attitude Toward Treatment | Report of Increased Symptoms | Report of Decrease in Symptoms | Patient Still Symptomatic | Patient Ideation |
---|
Cohort 1 | 3 | 2 | 4 | 3 | 1 | 1 |
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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
Intervention | units 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 1 | 76 | 76 | 52 | 57 | 57 | 57 | 48 | 66 | 64 | 76 | 76 | 76 | 72 | 63 | 72 | 71 | 76 |
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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
Intervention | nanogram per milliliter (Number) |
---|
| Participant 1- ARIPIPRAZOLE | Participant 1- DEHYDROARIPIPRAZOLE | Participant 2- OLANZAPINE | Participant 2- PALIPERIDONE | Participant 3- 7-OH QUETIAPINE | Participant 3-NORQUETIAPINE | Participant 3-QUETIAPINE | Participant 3-QUETIAPINE SULFOXIDE | Participant 5-7-OH QUETIAPINE | Participant 5-NORQUETIAPINE | Participant 5-QUETIAPINE | Participant 5-QUETIAPINE SULFOXIDE | Participant 6-ARIPIPRAZOLE | Participant 6-DEHYDROARIPIPRAZOLE | Participant 7-PALIPERIDONE | Participant 7-RISPERIDONE | Participant 8-ARIPIPRAZOLE | Participant 8-DEHYDROARIPIPRAZOLE | Participant 9- 7-OH QUETIAPINE | Participant 9- NORQUETIAPINE | Participant 9- PALIPERIDONE | Participant 9- QUETIAPINE | Participant 9- QUETIAPINE SULFOXIDE | Participant 9- RISPERIDONE |
---|
Cohort 1 | 596.00 | 139.00 | 27.30 | 45.10 | 43.10 | 660.00 | 280.00 | 660.00 | 7.72 | 153.00 | 50.30 | 321.00 | 464.00 | 112.00 | 31.00 | 26.20 | 168.00 | 33.00 | 0.200 | 2.00 | 0.100 | 2.00 | 2.00 | 0.100 |
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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
Intervention | units 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 1 | 4 | 3 | 4 | 3 | 4 | 4 | 5 | 3 | 3 | 3 | 3 | 3 | 4 | 4 | 3 | 3 | 3 |
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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
Intervention | score 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
Intervention | Participants (Count of Participants) |
---|
Levomilnacipran | 21 |
Quetiapine | 24 |
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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
Intervention | Participants (Count of Participants) |
---|
Levomilnacipran | 13 |
Quetiapine | 13 |
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Remission Rate
Remission was defined as [>or=50% reduction in MADRS score with MADRS NCT02720198)
Timeframe: Week 8
Intervention | Participants (Count of Participants) |
---|
Levomilnacipran | 2 |
Quetiapine | 3 |
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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
Intervention | Participants (Count of Participants) |
---|
Levomilnacipran | 3 |
Quetiapine | 7 |
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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
Intervention | score on a scale (Mean) |
---|
Levomilnacipran | 2.28 |
Quetiapine | 2.90 |
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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
Intervention | score on a scale (Mean) |
---|
Levomilnacipran | 3.21 |
Quetiapine | 0.87 |
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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
Intervention | score 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
Intervention | score 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
Intervention | score 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
Intervention | score 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
Intervention | Days (Mean) |
---|
Quetiapine | 2.3 |
Placebo | 3.3 |
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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
Intervention | Proportion of Specimens (Median) |
---|
Quetiapine | 0 |
Placebo | 0 |
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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
Intervention | score 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
Intervention | score 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
Intervention | score on a scale (Mean) |
---|
Quetiapine | -1.8 |
Placebo | 0.4 |
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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.
Intervention | Participants (Count of Participants) |
---|
Dose Reduction | 130 |
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MADRS Response Rates
Defined as a 50% score reduction from baseline. (NCT03207438)
Timeframe: Day 4 - Week 6
Intervention | Participants (Count of Participants) |
---|
| Day 4 | Week 1 | Week 2 | Week 4 | Week 6 |
---|
Placebo 1 - Insomnia | 6 | 12 | 31 | 44 | 45 |
,Placebo 1 - No Insomnia | 0 | 1 | 1 | 8 | 5 |
,Quetiapine XR 50mg - Insomnia | 8 | 26 | 42 | 59 | 64 |
,Quetiapine XR 50mg - No Insomnia | 0 | 3 | 8 | 5 | 9 |
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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
Intervention | Participants (Count of Participants) |
---|
| Week 1 | Week 2 | Week 4 | Week 6 |
---|
Placebo 2 - Melancholic Depression | 28 | 41 | 62 | 64 |
,Placebo 2 - Nonmelancholic Depression | 47 | 100 | 136 | 174 |
,Quetiapine XR 150-300mg - Melancholic Depression | 63 | 105 | 124 | 141 |
,Quetiapine XR 150-300mg - Nonmelancholic Depression | 86 | 195 | 251 | 274 |
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Modified MADRS Response Rates
50% score reduction from baseline calculated without Item 4 (reduced sleep). (NCT03207438)
Timeframe: 1 - 6 weeks
Intervention | Participants (Count of Participants) |
---|
| Week 1 | Week 2 | Week 4 | Week 6 |
---|
Placebo 2 - Melancholic Depression | 26 | 45 | 61 | 64 |
,Placebo 2 - Nonmelancholic Depression | 46 | 100 | 136 | 176 |
,Quetiapine XR 150-300mg - Melancholic Depression | 53 | 90 | 124 | 132 |
,Quetiapine XR 150-300mg - Nonmelancholic Depression | 68 | 179 | 231 | 260 |
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Modified MADRS Response Rate
Calculated without Item 4 (reduced sleep). (NCT03207438)
Timeframe: Day 4 - Week 6
Intervention | Participants (Count of Participants) |
---|
| Day 4 | Week 1 | Week 2 | Week 4 | Week 6 |
---|
Placebo 1 | 6 | 11 | 28 | 49 | 51 |
,Quetiapine XR 50mg | 6 | 22 | 44 | 57 | 66 |
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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)
Intervention | percentage of participants (Number) |
---|
| 0=No Event | 1=Wish to be Dead | 2 = Non-Specific Active Suicidal Thoughts | 3 = Suicidal Ideation Without Plan and Intent | 4 = Suicidal Ideation Intent to Act Without Plan | 5 = Suicidal Ideation With Plan and Intent | 6 = Preparatory Acts or Behavior | 7 = Aborted Attempt | 8 = Interrupted Attempt | 9 = Actual Attempt | 10 = Completed Suicide |
---|
Quetiapine XR | 100 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
,Seltorexant | 100 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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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
Intervention | percentage of participants (Number) |
---|
Seltorexant | 16.7 |
Quetiapine XR | 0 |
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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
Intervention | percentage of participants (Number) |
---|
Seltorexant | 0 |
Quetiapine XR | 0 |
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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
Intervention | percentage of participants (Number) |
---|
Seltorexant | 25.0 |
Quetiapine XR | 37.5 |
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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
Intervention | percentage of participants (Number) |
---|
Seltorexant | 38.7 |
Quetiapine XR | 36.0 |
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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)
Intervention | percentage of participants (Number) |
---|
Seltorexant | 64.3 |
Quetiapine XR | 75.6 |
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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)
Intervention | percentage of participants (Number) |
---|
Seltorexant | 0 |
Quetiapine XR | 0 |
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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
Intervention | percentage of participants (Number) |
---|
Seltorexant | 0 |
Quetiapine XR | 0 |
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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
Intervention | percentage of participants (Number) |
---|
Seltorexant | 0 |
Quetiapine XR | 0 |
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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
Intervention | percentage of participants (Number) |
---|
Seltorexant | 9.1 |
Quetiapine XR | 25.0 |
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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
Intervention | percentage of participants (Number) |
---|
Seltorexant | 0 |
Quetiapine XR | 0 |
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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
Intervention | percentage of participants (Number) |
---|
Seltorexant | 13.2 |
Quetiapine XR | 19.4 |
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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
Intervention | percentage of participants (Number) |
---|
Seltorexant | 13.2 |
Quetiapine XR | 22.2 |
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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
Intervention | percentage of participants (Number) |
---|
Seltorexant | 65.4 |
Quetiapine XR | 80.8 |
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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
Intervention | percentage of participants (Number) |
---|
Seltorexant | 4.3 |
Quetiapine XR | 8.5 |
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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
Intervention | days (Median) |
---|
Seltorexant | NA |
Quetiapine XR | NA |
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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
Intervention | units on a scale (Mean) |
---|
| Total Recall: Week 6 | Total Recall: Week 12 | Total Recall: Week 24 | Delayed Recall: Week 6 | Delayed Recall: Week 12 | Delayed Recall: Week 24 | Total True-Positive Errors: Week 6 | Total True-Positive Errors: Week 12 | Total True-Positive Errors: Week 24 | Recognition Discrimination Index: Week 6 | Recognition Discrimination Index: Week 12 | Recognition Discrimination Index: Week 24 |
---|
Quetiapine XR | -0.1 | 1.3 | 1.4 | 0.6 | 1.0 | 1.4 | -0.4 | -0.1 | -0.7 | 1.0 | 0.1 | -0.3 |
,Seltorexant | 0.6 | 1.9 | 2.0 | 0.2 | 0.5 | 1.3 | 0.5 | 0.2 | 0.5 | 0.8 | -0.3 | 0.9 |
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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
Intervention | score on a scale (Mean) |
---|
| Baseline ISI score <15 | Baseline 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
Intervention | score on a scale (Mean) |
---|
| Baseline ISI score <15 | Baseline 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
Intervention | score on a scale (Mean) |
---|
| Baseline ISI score <15 | Baseline 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
Intervention | score on a scale (Mean) |
---|
| Week 2 | Week 4 | Week 6 | Week 12 | Week 18 | Week 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
Intervention | percentage of participants (Number) |
---|
| Supine Pulse Rate: Abnormally low | Supine Pulse Rate: Abnormally high | Standing Pulse Rate: Abnormally low | Standing Pulse Rate: Abnormally high | Supine Systolic Blood Pressure: Abnormally low | Supine Systolic Blood Pressure: Abnormally high | Standing Systolic Blood Pressure: Abnormally low | Standing Systolic Blood Pressure: Abnormally high | Supine Diastolic Blood Pressure: Abnormally low | Supine Diastolic Blood Pressure: Abnormally high | Standing Diastolic Blood Pressure: Abnormally low | Standing Diastolic Blood Pressure: Abnormally high | Temperature: Abnormally low | Temperature: Abnormally high | Weight: Abnormally low | Weight: Abnormally high |
---|
Quetiapine XR | 2.0 | 3.9 | 0 | 5.9 | 0 | 0 | 2.0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 8.5 |
,Seltorexant | 0 | 2.0 | 0 | 2.0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2.0 | 0 | 6.0 | 4.3 | 4.3 |
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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
Intervention | percentage of participants (Number) |
---|
Seltorexant | 3.2 |
Quetiapine XR | 4.0 |
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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
Intervention | score on a scale (Mean) |
---|
| Week 2 | Week 4 | Week 6 | Week 12 | Week 18 | Week 24 | Week 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
Intervention | score on a scale (Mean) |
---|
| Week 2 | Week 4 | Week 6 | Week 12 | Week 18 | Week 24 | Week 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 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
Intervention | units on a scale (Mean) |
---|
| Week 12 | Week 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
Intervention | nanomoles per liter (nmol/L) (Mean) |
---|
| Awakening: Week 6 | Awakening: Week 24 | Evening: Week 6 | Evening: Week 24 |
---|
Quetiapine XR | -2.8 | -1.7 | 0.5 | 0.9 |
,Seltorexant | 1.3 | 1.4 | -0.7 | 1.4 |
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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
Intervention | units on a scale (Mean) |
---|
| Week 6 | Week 12 | Week 24 |
---|
Quetiapine XR | -2.9 | 0.1 | 0.0 |
,Seltorexant | 5.0 | 5.5 | 4.7 |
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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
Intervention | units on a scale (Mean) |
---|
| Week 12 | Week 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
Intervention | percentage of participants (Number) |
---|
Seltorexant | 7.1 |
Quetiapine XR | 13.6 |
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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
Intervention | units on a scale (Mean) |
---|
| Week 12 | Week 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
Intervention | units on a scale (Mean) |
---|
| Week 12 | Week 18 | Week 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
Intervention | units on a scale (Mean) |
---|
| Week 12 | Week 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
Intervention | units on a scale (Mean) |
---|
| Week 6 | Week 12 | Week 24 |
---|
Quetiapine XR | 0.0 | 0.6 | -0.3 |
,Seltorexant | 0.4 | 0.2 | 0.5 |
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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
Intervention | percentage 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 XR | 33.3 | 53.6 | 0 | 0 | 0 | 10.7 | 0 | 14.3 | 0 | 39.3 | 33.3 | 85.7 | 66.7 | 60.7 | 66.7 | 39.3 | 33.3 | 32.1 | 0 | 7.1 | 66.7 | 46.4 | 66.7 | 25.0 | 66.7 | 21.4 | 33.3 | 14.3 | 0 | 17.9 | 0 | 3.6 | 33.3 | 85.7 | 33.3 | 10.7 | 33.3 | 14.3 | 33.3 | 14.3 |
,Seltorexant | 75.0 | 33.3 | 0 | 6.7 | 0 | 6.7 | 0 | 0 | 0 | 26.7 | 0 | 23.3 | 50.0 | 40.0 | 50.0 | 33.3 | 0 | 16.7 | 0 | 6.7 | 75.0 | 33.3 | 75.0 | 23.3 | 25.0 | 10.0 | 50.0 | 16.7 | 0 | 3.3 | 0 | 3.3 | 25.0 | 10.0 | 25.0 | 26.7 | 0 | 3.3 | 25.0 | 3.3 |
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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
Intervention | percentage of participants (Number) |
---|
| SAEs | AESIs |
---|
Quetiapine XR | 3.8 | 5.8 |
,Seltorexant | 1.9 | 13.5 |
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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
Intervention | participants (Number) |
---|
| Baseline | Week 6 | Week 12 |
---|
ASP4345 150 mg | 0 | 0 | 0 |
,ASP4345 50 mg | 0 | 0 | 0 |
,Placebo | 0 | 0 | 0 |
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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
Intervention | participants (Number) |
---|
| Baseline | Week 6 | Week 12 |
---|
ASP4345 150 mg | 0 | 0 | 0 |
,ASP4345 50 mg | 0 | 0 | 0 |
,Placebo | 0 | 0 | 0 |
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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)
Intervention | T-score (Least Squares Mean) |
---|
Placebo | 1.15 |
ASP4345 50 mg | 1.34 |
ASP4345 150 mg | 0.87 |
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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)
Intervention | participants (Number) |
---|
Placebo | 0 |
ASP4345 50 mg | 0 |
ASP4345 150 mg | 0 |
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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
Intervention | participants (Number) |
---|
| Baseline | Week 6 | Week 12 |
---|
ASP4345 150 mg | 0 | 0 | 0 |
,ASP4345 50 mg | 0 | 0 | 0 |
,Placebo | 0 | 0 | 0 |
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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)
Intervention | participants (Number) |
---|
| TEAE | Drug-Related TEAEs | Serious TEAEs | Drug-Related Serious TEAE |
---|
ASP4345 150 mg | 28 | 11 | 1 | 0 |
,ASP4345 50 mg | 28 | 13 | 3 | 0 |
,Placebo | 45 | 11 | 1 | 0 |
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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
Intervention | nanogram per milliliter (ng/mL) (Mean) |
---|
| Day 7 Pre-dose | Day 14 Pre-dose | Day 21 Pre-dose | Day 42 Pre-dose | Day 84 Pre-dose |
---|
ASP4345 150 mg | 483.84 | 428.88 | 384.48 | 471.78 | 433.56 |
,ASP4345 50 mg | 175.041 | 182.903 | 172.040 | 207.145 | 204.914 |
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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
Intervention | percentage of days (Mean) |
---|
Schizophrenia | 64.34 |
Schizoaffective Disorder | 62.99 |
First Episode Psychosis | 62.51 |
Total | 63.37 |
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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
Intervention | percentage of MITs (Mean) |
---|
Schizophrenia | 88.94 |
Schizoaffective Disorder | 72.29 |
First Episode Psychosis | 91.04 |
Total | 86.57 |
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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
Intervention | Participants (Count of Participants) |
---|
Placebo | 1 |
Quetiapine | 3 |
Pimavanserin 34 mg | 1 |
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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
Intervention | Units on scale (Mean) |
---|
| Physical Functioning Week 8 | Physical Functioning Week 12 | Physical Functioning Week 16 | Physical Functioning Week 20 | Physical Functioning Week 24 | Physical Functioning Week 28 | Physical Functioning Week 32 | Role-Physical Week 8 | Role-Physical Week 12 | Role-Physical Week 16 | Role-Physical Week 20 | Role-Physical Week 24 | Role-Physical Week 28 | Role-Physical Week 32 | Body Pain Week 8 | Body Pain Week 12 | Body Pain Week 16 | Body Pain Week 20 | Body Pain Week 24 | Body Pain Week 28 | Body Pain Week 32 | General Health Week 8 | General Health Week 12 | General Health Week 16 | General Health Week 20 | General Health Week 24 | General Health Week 28 | General Health Week 32 | Vitality Week 8 | Vitality Week 12 | Vitality Week 16 | Vitality Week 20 | Vitality Week 24 | Vitality Week 28 | Vitality Week 32 | Social Functioning Week 8 | Social Functioning Week 12 | Social Functioning Week 16 | Social Functioning Week 20 | Social Functioning Week 24 | Social Functioning Week 28 | Social Functioning Week 32 | Role-Emotional Week 8 | Role-Emotional Week 12 | Role-Emotional Week 16 | Role-Emotional Week 20 | Role-Emotional Week 24 | Role-Emotional Week 28 | Role-Emotional Week 32 | Mental Health Week 8 | Mental Health Week 12 | Mental Health Week 16 | Mental Health Week 20 | Mental Health Week 24 | Mental Health Week 28 | Mental Health Week 32 |
---|
Esketamine Nasal Spray + Oral Antidepressant (AD) | 5.1 | 5.3 | 5.6 | 5.5 | 5.6 | 5.6 | 6.0 | 7.4 | 8.3 | 9.3 | 9.1 | 9.2 | 9.4 | 10.2 | 4.4 | 4.8 | 5.2 | 5.2 | 5.6 | 5.4 | 6.0 | 6.9 | 7.4 | 8.0 | 8.1 | 8.2 | 8.6 | 9.2 | 11.1 | 11.7 | 12.3 | 12.3 | 12.2 | 12.8 | 13.8 | 10.7 | 11.4 | 12.2 | 12.3 | 12.7 | 13.0 | 14.0 | 12.0 | 12.7 | 14.2 | 14.3 | 14.3 | 15.2 | 16.0 | 12.9 | 14.0 | 14.7 | 15.0 | 14.8 | 15.5 | 16.3 |
,Quetiapine Extended Release (XR) + Oral AD | 3.2 | 3.9 | 4.2 | 4.0 | 4.4 | 4.5 | 4.6 | 5.3 | 5.7 | 6.2 | 6.3 | 6.9 | 6.8 | 7.2 | 3.5 | 4.2 | 4.3 | 4.5 | 4.4 | 4.5 | 5.0 | 4.9 | 5.1 | 5.6 | 5.5 | 5.6 | 6.1 | 6.7 | 7.8 | 8.7 | 9.5 | 9.6 | 9.6 | 10.1 | 10.4 | 7.6 | 8.6 | 9.0 | 9.1 | 9.5 | 9.8 | 10.3 | 8.6 | 9.8 | 10.3 | 10.4 | 11.2 | 11.2 | 11.2 | 9.8 | 10.6 | 10.9 | 11.2 | 11.5 | 12.2 | 12.6 |
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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
Intervention | Units on Scale (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 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
Intervention | Units on Scale (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 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
Intervention | Units on scale (Mean) |
---|
| Absenteeism Week 4 | Absenteeism Week 8 | Absenteeism Week 12 | Absenteeism Week 16 | Absenteeism Week 20 | Absenteeism Week 24 | Absenteeism Week 28 | Absenteeism Week 32 | Presenteeism Week 4 | Presenteeism Week 8 | Presenteeism Week 12 | Presenteeism Week 16 | Presenteeism Week 20 | Presenteeism Week 24 | Presenteeism Week 28 | Presenteeism Week 32 | Work productivity loss Week 4 | Work productivity loss Week 8 | Work productivity loss Week 12 | Work productivity loss Week 16 | Work productivity loss Week 20 | Work productivity loss Week 24 | Work productivity loss Week 28 | Work productivity loss Week 32 | Activity Impairment Week 4 | Activity Impairment Week 8 | Activity Impairment Week 12 | Activity Impairment Week 16 | Activity Impairment Week 20 | Activity Impairment Week 24 | Activity Impairment Week 28 | Activity 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
Intervention | Units on scale (Mean) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 |
---|
Esketamine Nasal Spray + Oral Antidepressant (AD) | 3.3 | 2.9 | 2.7 | 2.4 | 2.1 | 2.0 | 1.9 | 1.8 | 1.8 | 1.7 | 1.6 |
,Quetiapine Extended Release (XR) + Oral AD | 3.6 | 3.3 | 3.1 | 2.9 | 2.4 | 2.3 | 2.2 | 2.1 | 2.0 | 2.0 | 1.9 |
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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
Intervention | Participants (Count of Participants) |
---|
| Very much improved at Week 2 | Much improved at Week 2 | Minimally improved at Week 2 | No change at Week 2 | Minimally worse at Week 2 | Much worse at Week 2 | Very much worse at Week 2 | Very much improved at Week 3 | Much improved at Week 3 | Minimally improved at Week 3 | No change at Week 3 | Minimally worse at Week 3 | Much worse at Week 3 | Very much worse at Week 3 | Very much improved at Week 4 | Much improved at Week 4 | Minimally improved at Week 4 | No change at Week 4 | Minimally worse at Week 4 | Much worse at Week 4 | Very much worse at Week 4 | Very much improved at Week 8 | Much improved at Week 8 | Minimally improved at Week 8 | No change at Week 8 | Minimally worse at Week 8 | Much worse at Week 8 | Very much worse at Week 8 | Very much improved at Week 12 | Much improved at Week 12 | Minimally improved at Week 12 | No change at Week 12 | Minimally worse at Week 12 | Much worse at Week 12 | Very much worse at Week 12 | Very much improved at Week 16 | Much improved at Week 16 | Minimally improved at Week 16 | No change at Week 16 | Minimally worse at Week 16 | Much worse at Week 16 | Very much worse at Week 16 | Very much improved at Week 20 | Much improved at Week 20 | Minimally improved at Week 20 | No change at Week 20 | Minimally worse at Week 20 | Much worse at Week 20 | Very much worse at Week 20 | Very much improved at Week 24 | Much improved at Week 24 | Minimally improved at Week 24 | No change at Week 24 | Minimally worse at Week 24 | Much worse at Week 24 | Very much worse at Week 24 | Very much improved at Week 28 | Much improved at Week 28 | Minimally improved at Week 28 | No change at Week 28 | Minimally worse at Week 28 | Much worse at Week 28 | Very much worse at Week 28 | Very much improved at Week 32 | Much improved at Week 32 | Minimally improved at Week 32 | No change at Week 32 | Minimally worse at Week 32 | Much worse at Week 32 | Very much worse at Week 32 |
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Esketamine Nasal Spray + Oral Antidepressant (AD) | 6 | 97 | 141 | 75 | 6 | 1 | 1 | 14 | 126 | 135 | 45 | 6 | 0 | 1 | 41 | 150 | 102 | 29 | 4 | 0 | 1 | 68 | 165 | 68 | 18 | 5 | 2 | 1 | 83 | 156 | 53 | 24 | 9 | 1 | 1 | 100 | 136 | 58 | 25 | 5 | 2 | 1 | 106 | 137 | 55 | 19 | 7 | 2 | 1 | 123 | 123 | 48 | 25 | 6 | 1 | 1 | 127 | 121 | 46 | 24 | 7 | 1 | 1 | 148 | 103 | 42 | 28 | 4 | 1 | 1 |
,Quetiapine Extended Release (XR) + Oral AD | 4 | 39 | 149 | 108 | 26 | 5 | 0 | 8 | 57 | 159 | 81 | 20 | 6 | 0 | 17 | 83 | 152 | 52 | 17 | 10 | 0 | 38 | 118 | 105 | 44 | 16 | 10 | 0 | 45 | 120 | 92 | 47 | 18 | 9 | 0 | 55 | 111 | 84 | 49 | 23 | 9 | 0 | 61 | 110 | 83 | 49 | 19 | 9 | 0 | 64 | 109 | 86 | 44 | 19 | 9 | 0 | 71 | 104 | 80 | 48 | 19 | 9 | 0 | 82 | 96 | 81 | 43 | 20 | 9 | 0 |
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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
Intervention | Unit on scale (Mean) |
---|
| Week 2 | Week 4 | Week 6 | Week 8 | Week 10 | Week 12 | Week 14 | Week 16 | Week 18 | Week 20 | Week 22 | Week 24 | Week 26 | Week 28 | Week 30 | Week 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
Intervention | Unit on scale (Mean) |
---|
| Week 1 | Week 2 | Week 4 | Week 6 | Week 8 | Week 10 | Week 12 | Week 14 | Week 16 | Week 18 | Week 20 | Week 22 | Week 24 | Week 26 | Week 28 | Week 30 | Week 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
Intervention | Units on scale (Mean) |
---|
| Week 2 | Week 4 | Week 6 | Week 8 | Week 10 | Week 12 | Week 14 | Week 16 | Week 18 | Week 20 | Week 22 | Week 24 | Week 26 | Week 28 | Week 30 | Week 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
Intervention | Units on scale (Mean) |
---|
| Week 2 | Week 4 | Week 6 | Week 8 | Week 10 | Week 12 | Week 14 | Week 16 | Week 18 | Week 20 | Week 22 | Week 24 | Week 26 | Week 28 | Week 30 | Week 32 |
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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
Intervention | Participants (Count of Participants) |
---|
Esketamine Nasal Spray + Oral Antidepressant (AD) | 223 |
Quetiapine Extended Release (XR) + Oral AD | 140 |
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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
Intervention | Units on scale (Mean) |
---|
| Week 1 | Week 2 | Week 3 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 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
Intervention | Units on scale (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 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
Intervention | Units on scale (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 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
Intervention | Units on Scale (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 |
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Esketamine Nasal Spray + Oral Antidepressant (AD) | 13.3 | 18.9 | 20.9 | 21.9 | 22.3 | 23.6 | 25.2 | 24.9 |
,Quetiapine Extended Release (XR) + Oral AD | 9.7 | 16.1 | 17.2 | 20.2 | 19.6 | 21.8 | 23.2 | 24.5 |
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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
Intervention | Units on scale (Mean) |
---|
| Absenteeism Week 4 | Absenteeism Week 8 | Absenteeism Week 12 | Absenteeism Week 16 | Absenteeism Week 20 | Absenteeism Week 24 | Absenteeism Week 28 | Absenteeism Week 32 | Presenteeism Week 4 | Presenteeism Week 8 | Presenteeism Week 12 | Presenteeism Week 16 | Presenteeism Week 20 | Presenteeism Week 24 | Presenteeism Week 28 | Presenteeism Week 32 | Work productivity loss Week 4 | Work productivity loss Week 8 | Work productivity loss Week 12 | Work productivity loss Week 16 | Work productivity loss Week 20 | Work productivity loss Week 24 | Work productivity loss Week 28 | Work productivity loss Week 32 | Activity Impairment Week 4 | Activity Impairment Week 8 | Activity Impairment Week 12 | Activity Impairment Week 16 | Activity Impairment Week 20 | Activity Impairment Week 24 | Activity Impairment Week 28 | Activity 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
Intervention | Units on Scale (Mean) |
---|
| Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 32 |
---|
Esketamine Nasal Spray + Oral Antidepressant (AD) | 13.3 | 18.2 | 19.4 | 20.2 | 20.4 | 21.3 | 21.9 | 22.3 |
,Quetiapine Extended Release (XR) + Oral AD | 9.7 | 14.0 | 14.4 | 16.1 | 15.4 | 16.9 | 17.3 | 18.0 |
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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
Intervention | Percentage of participants (Number) |
---|
Esketamine Nasal Spray + Oral Antidepressant (AD) | 27.1 |
Quetiapine Extended Release (XR) + Oral AD | 17.6 |
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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
Intervention | Percentage of Participants (Number) |
---|
Esketamine Nasal Spray + Oral Antidepressant (AD) | 21.7 |
Quetiapine Extended Release (XR) + Oral AD | 14.1 |
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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
Intervention | Units on scale (Mean) |
---|
| Week 2 | Week 3 | Week 4 | Week 8 | Week 12 | Week 16 | Week 20 | Week 24 | Week 28 | Week 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
Intervention | Participants (Count of Participants) |
---|
Esketamine Nasal Spray + Oral Antidepressant (AD) | 307 |
Quetiapine Extended Release (XR) + Oral AD | 262 |
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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
Intervention | Participants (Count of Participants) |
---|
| Suicidal Ideation Week 1 | Suicidal Behavior Week 1 | Suicidal Ideation Week 2 | Suicidal Behavior Week 2 | Suicidal Ideation Week 3 | Suicidal Behavior Week 3 | Suicidal Ideation Week 4 | Suicidal Behavior Week 4 | Suicidal Ideation Week 8 | Suicidal Behavior Week 8 | Suicidal Ideation Week 12 | Suicidal Behavior Week 12 | Suicidal Ideation Week 16 | Suicidal Behavior Week 16 | Suicidal Ideation Week 20 | Suicidal Behavior Week 20 | Suicidal Ideation Week 24 | Suicidal Behavior Week 24 | Suicidal Ideation Week 28 | Suicidal Behavior Week 28 | Suicidal Ideation Week 32 | Suicidal Behavior Week 32 |
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Esketamine Nasal Spray + Oral Antidepressant (AD) | 22 | 0 | 21 | 0 | 19 | 0 | 22 | 0 | 21 | 0 | 13 | 0 | 12 | 1 | 15 | 0 | 14 | 0 | 8 | 0 | 7 | 0 |
,Quetiapine Extended Release (XR) + Oral AD | 25 | 0 | 32 | 1 | 17 | 0 | 27 | 0 | 18 | 0 | 14 | 0 | 12 | 1 | 14 | 0 | 9 | 0 | 5 | 0 | 4 | 1 |
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