Page last updated: 2024-11-13

aripiprazole lauroxil

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

Cross-References

ID SourceID
PubMed CID49831411
CHEMBL ID2219425
CHEBI ID90930
SCHEMBL ID1044330
MeSH IDM000613234

Synonyms (48)

Synonym
alks-9070
alks-9072
aristada initio
rdc3317
CHEMBL2219425
rdc 3317
alks 9070
1259305-29-7
b786j7a343 ,
unii-b786j7a343
aripiprazole lauroxil ,
dodecanoic acid, (7-(4-(4-(2,3-dichlorophenyl)-1-piperazinyl)butoxy)-3,4-dihydro-2-oxo-1(2h)-quinolinyl)methyl ester
alks 9072
(7-(4-(4-(2,3-dichlorophenyl)piperazin-1-yl)butoxy)-2-oxo-3,4-dihydroquinolin-1(2h)-yl)methyl dodecanoate
aristada
aripiprazole lauroxil [usan]
rdc-3317
aripiprazole lauroxil (usan)
D10364
aristada (tn)
SCHEMBL1044330
aripiprazole lauroxil [mi]
aripiprazole lauroxil [who-dd]
aripiprazole lauroxil [orange book]
CHEBI:90930 ,
[7-{4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy}-2-oxo-3,4-dihydroquinolin-1(2h)-yl]methyl dodecanoate
[7-[4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy]-2-oxo-3,4-dihydroquinolin-1-yl]methyl dodecanoate
DTXSID60154997 ,
dodecanoic acid [7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2-oxo-1(2h)-quinolinyl]methyl ester
mfcd26967976
AKOS030627657
aripiprazol- lauroxil
DB14185
AS-35241
Q25323757
EX-A4069
BCP14993
aripiprazole-lauroxil
HY-108751
CS-0030962
NCGC00532501-01
A856290
dtxcid5077488
aristada initio kit
dodecanoic acid, [7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2-oxo-1(2h)-quinolinyl]methyl ester
(7-{4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy}-2-oxo-1,2,3,4-tetrahydroquinolin-1-yl)methyl dodecanoate
EN300-7416466
AC-36504

Research Excerpts

Overview

Aripiprazole lauroxil (AL) is a long-acting atypical antipsychotic approved for the treatment of schizophrenia in adults. It is an extended-release prodrug of aripipazole for intramuscular injection, approved for schizophrenia treatment.

ExcerptReferenceRelevance
"Aripiprazole lauroxil (AL) is a long-acting injectable antipsychotic approved for treatment of schizophrenia in adults. "( Pharmacokinetics, Safety, and Tolerability of a 2-Month Dose Interval Regimen of the Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil: Results From a 44-Week Phase I Study.
Du, Y; Hard, M; Marandi, M; von Moltke, L; Walling, DP; Wehr, A; Weiden, PJ, 2020
)
2.21
"Aripiprazole lauroxil (AL) is a long-acting atypical antipsychotic approved for the treatment of schizophrenia in adults. "( Aripiprazole Lauroxil Dosing Regimens: Understanding Dosage Strengths and Injection Intervals.
Du, Y; Faldu, S; Rege, B; Sommi, RW; Wehr, A; Weiden, PJ, 2022
)
3.61
"Aripiprazole lauroxil is an extended-release prodrug of aripiprazole for intramuscular injection, approved for schizophrenia treatment. "( Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia.
Citrome, L; Hard, ML; Mills, RJ; Sadler, BM; Turncliff, RZ, 2017
)
3.34
"Aripiprazole lauroxil (AL) is a long-acting injectable medication approved for the treatment of schizophrenia. "( Pharmacokinetic Profile of a 2-Month Dose Regimen of Aripiprazole Lauroxil: A Phase I Study and a Population Pharmacokinetic Model.
Hard, ML; Mills, RJ; Sadler, BM; von Moltke, L; Wehr, AY; Weiden, PJ, 2017
)
2.15
"Aripiprazole lauroxil (AL) is a long-acting injectable atypical antipsychotic that was evaluated for the treatment of schizophrenia in a randomized, placebo-controlled, Phase 3 study. "( Effect of aripiprazole lauroxil in patients with acute schizophrenia as assessed by the Positive and Negative Syndrome Scale-supportive analyses from a Phase 3 study.
Citrome, L; Cutler, AJ; Du, Y; Nasrallah, HA; Risinger, R; Silverman, BL; Zummo, J, 2018
)
2.33
"Aripiprazole lauroxil (AL) is a long-acting injectable atypical antipsychotic recently approved for treatment of schizophrenia on the basis of a large-scale trial of two doses of AL versus placebo. "( Aripiprazole Lauroxil Compared with Paliperidone Palmitate in Patients with Schizophrenia: An Indirect Treatment Comparison.
Cameron, C; Desai, DN; Drake, C; Hutton, B; Kotb, A; Weiden, PJ; Zummo, J,
)
3.02
"Aripiprazole lauroxil (AL) is an FDA-approved treatment for schizophrenia. "( A Phase-1 Study Comparing Pharmacokinetic and Safety Profiles of Three Different Dose Intervals of Aripiprazole Lauroxil.
Hard, M; Risinger, R; Weiden, PJ, 2017
)
2.11
"Aripiprazole lauroxil (AL) is a long-acting injectable atypical antipsychotic recently approved for the treatment of schizophrenia."( Efficacy and safety of aripiprazole lauroxil once-monthly versus aripiprazole once-monthly long-acting injectable formulations in patients with acute symptoms of schizophrenia: an indirect comparison of two double-blind placebo-controlled studies.
Cameron, C; Desai, D; Drake, C; Hutton, B; Kotb, A; Weiden, PJ; Zummo, J, 2018
)
2.23
"Aripiprazole lauroxil is an LAI that offers multiple dosing options but requires oral treatment overlap during initiation for the first 21 consecutive days."( Aripiprazole Lauroxil NanoCrystal
Clark, C; Davis, E; Ehret, MJ; Luttrell, SE,
)
2.3

Treatment

ExcerptReferenceRelevance
"Treatment with aripiprazole lauroxil resulted in decreases in agitation and hostility in patients with schizophrenia and this antihostility effect appears to be independent of a general antipsychotic effect."( Effect of aripiprazole lauroxil on agitation and hostility in patients with schizophrenia.
Bose, A; Citrome, L; Claxton, A; Du, Y; Ehrich, EW; Risinger, R; Silverman, BL; Stankovic, S; Zummo, J, 2016
)
1.18

Toxicity

ExcerptReferenceRelevance
" The incidence of treatment-emergent adverse events (AEs) was evaluated."( Effect of Aripiprazole Lauroxil on Metabolic and Endocrine Profiles and Related Safety Considerations Among Patients With Acute Schizophrenia.
Bose, A; Du, Y; Ehrich, EW; Nasrallah, HA; Newcomer, JW; Risinger, R; Silverman, BL; Stankovic, S; Zummo, J, 2016
)
0.84
" Common adverse events (>5%) were schizophrenia, akathisia, headache, insomnia, and anxiety."( Efficacy and safety of aripiprazole lauroxil in schizophrenic patients presenting with severe psychotic symptoms during an acute exacerbation.
Bose, A; Du, Y; Ehrich, E; Potkin, SG; Risinger, R; Silverman, B; Stankovic, S; Zummo, J, 2017
)
0.77
" The most common adverse event (AE) for all groups was injection-site reaction (pain)."( A Phase-1 Study Comparing Pharmacokinetic and Safety Profiles of Three Different Dose Intervals of Aripiprazole Lauroxil.
Hard, M; Risinger, R; Weiden, PJ, 2017
)
0.67
" The analysis indirectly compared AL and AOM treatment groups for efficacy by mean change in Positive and Negative Syndrome Scale (PANSS) total score and ≥30% reduction in PANSS total score, as well as tolerability including adverse events, akathisia, and weight gain."( Efficacy and safety of aripiprazole lauroxil once-monthly versus aripiprazole once-monthly long-acting injectable formulations in patients with acute symptoms of schizophrenia: an indirect comparison of two double-blind placebo-controlled studies.
Cameron, C; Desai, D; Drake, C; Hutton, B; Kotb, A; Weiden, PJ; Zummo, J, 2018
)
0.79
" Overall, adverse event (AE) rates experienced over 12 weeks were modest; no AEs were considered serious."( Switching stable patients with schizophrenia from their oral antipsychotics to aripiprazole lauroxil: a post hoc safety analysis of the initial 12-week crossover period.
Du, Y; Liu, CC; Stanford, AD; Weiden, PJ, 2019
)
0.74
" Safety endpoints included adverse events (AEs) and extrapyramidal symptoms (EPS) including akathisia, injection-site reactions (ISRs), and clinically relevant changes in metabolic and endocrine values."( Long-term safety and tolerability of aripiprazole lauroxil in patients with schizophrenia.
Aquila, R; Claxton, A; Du, Y; Nasrallah, HA; Stanford, AD; Weiden, PJ, 2019
)
0.79
" Adverse events (AEs) and laboratory data were monitored."( Efficacy and Safety of a 2-Month Formulation of Aripiprazole Lauroxil With 1-Day Initiation in Patients Hospitalized for Acute Schizophrenia Transitioned to Outpatient Care: Phase 3, Randomized, Double-Blind, Active-Control ALPINE Study.
Bidollari, I; Cash, E; Claxton, A; Du, Y; Keane, E; Kunovac, J; Walling, DP; Weiden, PJ; Yagoda, S; Yao, B, 2020
)
0.81
" Overall incidence by group of any adverse events (AEs) throughout the study was 68."( Pharmacokinetics, Safety, and Tolerability of a 2-Month Dose Interval Regimen of the Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil: Results From a 44-Week Phase I Study.
Du, Y; Hard, M; Marandi, M; von Moltke, L; Walling, DP; Wehr, A; Weiden, PJ, 2020
)
0.77
" Safety metrics included adverse events (AEs), AEs leading to study discontinuations, physical examinations, laboratory parameters, and extrapyramidal symptom (EPS) rating scales."( Beyond 52-Week Long-Term Safety: Long-Term Outcomes of Aripiprazole Lauroxil for Patients With Schizophrenia Continuing in an Extension Study.
Claxton, A; Du, Y; Lauriello, J; Weiden, PJ, 2020
)
0.81
" Patient-reported sexual and endocrine side effects were assessed on the UKU Side Effect Rating Scale sexual function subscale and analyzed in study completers."( Analysis of prolactin and sexual side effects in patients with schizophrenia who switched from paliperidone palmitate to aripiprazole lauroxil.
Bidollari, I; Claxton, A; Du, Y; Kelly, DL, 2021
)
0.83

Pharmacokinetics

ExcerptReferenceRelevance
" We developed a population pharmacokinetic (PopPK) model to characterize aripiprazole lauroxil PK and evaluate dosing scenarios likely to be encountered in clinical practice."( Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia.
Citrome, L; Hard, ML; Mills, RJ; Sadler, BM; Turncliff, RZ, 2017
)
2.13
"We examined the feasibility of a 2-month (every 8 weeks [q8wk]) dosing interval of AL in a phase I open-label pharmacokinetic study investigating AL 1064 mg administered q8wk for 24 weeks, followed by 20 weeks of safety and pharmacokinetic measurements (ClinicalTrials."( Pharmacokinetic Profile of a 2-Month Dose Regimen of Aripiprazole Lauroxil: A Phase I Study and a Population Pharmacokinetic Model.
Hard, ML; Mills, RJ; Sadler, BM; von Moltke, L; Wehr, AY; Weiden, PJ, 2017
)
0.7
" Pharmacokinetic samples were collected at various time points during the 24-week study period and the 20-week follow-up period."( Pharmacokinetic Profile of a 2-Month Dose Regimen of Aripiprazole Lauroxil: A Phase I Study and a Population Pharmacokinetic Model.
Hard, ML; Mills, RJ; Sadler, BM; von Moltke, L; Wehr, AY; Weiden, PJ, 2017
)
0.7
" Here, a 6-month pharmacokinetic study compared 2 different initiation regimens for starting AL."( Pharmacokinetic Evaluation of a 1-Day Treatment Initiation Option for Starting Long-Acting Aripiprazole Lauroxil for Schizophrenia.
Du, Y; Hard, ML; von Moltke, L; Walling, D; Wehr, AY; Weiden, PJ, 2018
)
0.7
" The pharmacokinetic profile of the 1-day initiation regimen was comparable to the 21-day initiation regimen; both achieved aripiprazole concentrations in the therapeutic range within 4 days and remained in a comparable concentration range during treatment initiation."( Pharmacokinetic Evaluation of a 1-Day Treatment Initiation Option for Starting Long-Acting Aripiprazole Lauroxil for Schizophrenia.
Du, Y; Hard, ML; von Moltke, L; Walling, D; Wehr, AY; Weiden, PJ, 2018
)
0.7
" Plasma concentration samples were obtained at regular intervals to provide pharmacokinetic data for the duration of AL exposure and to measure persistence of plasma aripiprazole concentrations after AL discontinuation."( Pharmacokinetics, Safety, and Tolerability of a 2-Month Dose Interval Regimen of the Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil: Results From a 44-Week Phase I Study.
Du, Y; Hard, M; Marandi, M; von Moltke, L; Walling, DP; Wehr, A; Weiden, PJ, 2020
)
0.77

Dosage Studied

A dosing interval of 882 mg every 6 weeks results in concentrations that fall within the concentration range associated with the efficacious aripiprazole lauroxil dose range (441-882 mg dosed monthly) We developed a population pharmacokinetic (PopPK) model to evaluate dosing scenarios likely to be encountered in clinical practice.

ExcerptRelevanceReference
" The pharmacokinetic profile of AL also led to approval of dosing intervals of every 6 weeks for the 882 mg dose."( Aripiprazole long-acting injectable formulations for schizophrenia: aripiprazole monohydrate and aripiprazole lauroxil.
Citrome, L, 2016
)
0.65
" We developed a population pharmacokinetic (PopPK) model to characterize aripiprazole lauroxil PK and evaluate dosing scenarios likely to be encountered in clinical practice."( Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia.
Citrome, L; Hard, ML; Mills, RJ; Sadler, BM; Turncliff, RZ, 2017
)
2.13
" The model was subsequently used to evaluate various dose levels and frequency and the impact of dosing delay on aripiprazole concentrations."( Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia.
Citrome, L; Hard, ML; Mills, RJ; Sadler, BM; Turncliff, RZ, 2017
)
1.9
" Based on the PopPK model simulations, a dosing interval of 882 mg every 6 weeks results in aripiprazole concentrations that fall within the concentration range associated with the efficacious aripiprazole lauroxil dose range (441-882 mg dosed monthly)."( Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia.
Citrome, L; Hard, ML; Mills, RJ; Sadler, BM; Turncliff, RZ, 2017
)
2.09
"This PopPK model and model-based simulations were effective means for evaluating aripiprazole lauroxil dosing regimens and management of missed doses."( Aripiprazole Lauroxil: Pharmacokinetic Profile of This Long-Acting Injectable Antipsychotic in Persons With Schizophrenia.
Citrome, L; Hard, ML; Mills, RJ; Sadler, BM; Turncliff, RZ, 2017
)
2.12
"We examined the feasibility of a 2-month (every 8 weeks [q8wk]) dosing interval of AL in a phase I open-label pharmacokinetic study investigating AL 1064 mg administered q8wk for 24 weeks, followed by 20 weeks of safety and pharmacokinetic measurements (ClinicalTrials."( Pharmacokinetic Profile of a 2-Month Dose Regimen of Aripiprazole Lauroxil: A Phase I Study and a Population Pharmacokinetic Model.
Hard, ML; Mills, RJ; Sadler, BM; von Moltke, L; Wehr, AY; Weiden, PJ, 2017
)
0.7
" Study limitations included use of a fixed dose for initial oral aripiprazole and fixed monthly AL doses without the option to individualize the oral initiation dosing or injection frequency for efficacy, tolerability, or safety."( Effect of aripiprazole lauroxil in patients with acute schizophrenia as assessed by the Positive and Negative Syndrome Scale-supportive analyses from a Phase 3 study.
Citrome, L; Cutler, AJ; Du, Y; Nasrallah, HA; Risinger, R; Silverman, BL; Zummo, J, 2018
)
0.88
" The PK results from this study show that a dosing interval of every 8 weeks for the 1064 mg dose resulted in aripiprazole concentrations within the established therapeutic window for AL."( A Phase-1 Study Comparing Pharmacokinetic and Safety Profiles of Three Different Dose Intervals of Aripiprazole Lauroxil.
Hard, M; Risinger, R; Weiden, PJ, 2017
)
0.67
"Concomitant administration of the 1-day initiation regimen with all approved AL dosing regimens (441, 662, or 882 mg monthly, 882 mg every 6 weeks, or 1064 mg every 2 months) is predicted to achieve aripiprazole concentrations associated with therapeutic doses of AL using the 21-day initiation regimen within 4 days, maintaining these concentrations until the next AL dose."( Population Pharmacokinetic Analysis and Model-Based Simulations of Aripiprazole for a 1-Day Initiation Regimen for the Long-Acting Antipsychotic Aripiprazole Lauroxil.
Hard, ML; Mills, RJ; Sadler, BM; von Moltke, L; Wehr, AY, 2018
)
0.68
" Long-acting injectable (LAI) antipsychotics offer an extended dosing interval option for patients, although the current options may require an oral overlap at initiation."( Aripiprazole Lauroxil NanoCrystal
Clark, C; Davis, E; Ehret, MJ; Luttrell, SE,
)
1.57
"The dose-response relationships of antipsychotic drugs for schizophrenia are not well defined, but such information would be important for decision making by clinicians."( Dose-Response Meta-Analysis of Antipsychotic Drugs for Acute Schizophrenia.
Crippa, A; Davis, JM; Leucht, S; Orsini, N; Patel, MX; Siafis, S, 2020
)
0.56
" Dose-response curves were constructed with random-effects dose-response meta-analyses and a spline model."( Dose-Response Meta-Analysis of Antipsychotic Drugs for Acute Schizophrenia.
Crippa, A; Davis, JM; Leucht, S; Orsini, N; Patel, MX; Siafis, S, 2020
)
0.56
" For some drugs, higher than currently licensed doses might be tested in further trials, because their dose-response curves did not plateau."( Dose-Response Meta-Analysis of Antipsychotic Drugs for Acute Schizophrenia.
Crippa, A; Davis, JM; Leucht, S; Orsini, N; Patel, MX; Siafis, S, 2020
)
0.56
" Approved AL doses and dosing regimens include 441 mg monthly, 662 mg monthly, and 882 mg monthly or every 6 weeks (q6wk), as well as the most recently approved dose, 1064 mg, administered every 2 months."( Pharmacokinetics, Safety, and Tolerability of a 2-Month Dose Interval Regimen of the Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil: Results From a 44-Week Phase I Study.
Du, Y; Hard, M; Marandi, M; von Moltke, L; Walling, DP; Wehr, A; Weiden, PJ, 2020
)
0.77
"This study evaluated pharmacokinetics of AL given at a higher dosage strength (1064 mg) and at a longer dose interval (every 8 weeks [q8wk]) than previously studied."( Pharmacokinetics, Safety, and Tolerability of a 2-Month Dose Interval Regimen of the Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil: Results From a 44-Week Phase I Study.
Du, Y; Hard, M; Marandi, M; von Moltke, L; Walling, DP; Wehr, A; Weiden, PJ, 2020
)
0.77
"AL 1064 mg q8wk provided continuous exposure to aripiprazole throughout the 8-week dosing interval and had a safety profile consistent with the 4- and 6-week regimens."( Pharmacokinetics, Safety, and Tolerability of a 2-Month Dose Interval Regimen of the Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil: Results From a 44-Week Phase I Study.
Du, Y; Hard, M; Marandi, M; von Moltke, L; Walling, DP; Wehr, A; Weiden, PJ, 2020
)
0.77
" AL has five regimen options that offer three different injection intervals using four different dosage strengths."( Aripiprazole Lauroxil Dosing Regimens: Understanding Dosage Strengths and Injection Intervals.
Du, Y; Faldu, S; Rege, B; Sommi, RW; Wehr, A; Weiden, PJ, 2022
)
2.16
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (4)

RoleDescription
H1-receptor antagonistH1-receptor antagonists are the drugs that selectively bind to but do not activate histamine H1 receptors, thereby blocking the actions of endogenous histamine.
second generation antipsychoticAntipsychotic drugs which can have different modes of action but which tend to be less likely than first generation antipsychotics to cause extrapyramidal motor control disabilities such as body rigidity or Parkinson's disease-type movements.
serotonergic agonistAn agent that has an affinity for serotonin receptors and is able to mimic the effects of serotonin by stimulating the physiologic activity at the cell receptors. Serotonin agonists are used as antidepressants, anxiolytics, and in the treatment of migraine disorders.
prodrugA compound that, on administration, must undergo chemical conversion by metabolic processes before becoming the pharmacologically active drug for which it is a prodrug.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (7)

ClassDescription
dodecanoate esterAny fatty acid ester in which the carboxylic acid component is lauric acid.
quinolone
dichlorobenzeneAny member of the class of chlorobenzenes carrying two chloro groups at unspecified positions.
N-arylpiperazine
N-alkylpiperazine
aromatic etherAny ether in which the oxygen is attached to at least one aryl substituent.
delta-lactamA lactam in which the amide bond is contained within a six-membered ring, which includes the amide nitrogen and the carbonyl carbon.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Research

Studies (33)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's0 (0.00)29.6817
2010's24 (72.73)24.3611
2020's9 (27.27)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 54.59

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index54.59 (24.57)
Research Supply Index4.01 (2.92)
Research Growth Index4.57 (4.65)
Search Engine Demand Index85.33 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (54.59)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials18 (50.00%)5.53%
Reviews8 (22.22%)6.00%
Case Studies0 (0.00%)4.05%
Observational1 (2.78%)0.25%
Other9 (25.00%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (6)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase 3b, Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia in Subjects Hospitalized for Acute Exacerbation [NCT03345979]Phase 3200 participants (Actual)Interventional2017-11-15Completed
Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode [NCT04203056]Phase 415 participants (Actual)Interventional2019-12-16Terminated(stopped due to Withdraw of financial support by industry collaborator)
A Phase 1, Randomized, Open-Label Study Evaluating the Pharmacokinetics of Various Dosing Regimens of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia [NCT02320032]Phase 1140 participants (Actual)Interventional2014-12-31Completed
Safety and Tolerability of Initiating Aripiprazole Lauroxil in Subjects With Schizophrenia Who Are Inadequately Treated With Paliperidone Palmitate or Risperidone Long Acting Injection [NCT02634320]Phase 451 participants (Actual)Interventional2015-12-31Completed
A Phase 1, Randomized, Open-label, Single Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Aripiprazole Lauroxil Following Administration to the Deltoid or Gluteal Muscle in Adults With Schizophrenia or Schizoaffective Disorder [NCT02636842]Phase 147 participants (Actual)Interventional2015-12-31Completed
Comprehensive Treatment of Early Course Schizophrenia: A Nonrandomized Study of Long Acting Injectable Antipsychotic Medication Combined With Cognitive and Functional Skills Training [NCT05662306]Phase 460 participants (Anticipated)Interventional2024-02-01Recruiting
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT02634320 (6) [back to overview]Change From Baseline to Last Treatment Visit in Brief Psychiatric Rating Scale (BPRS) Scores
NCT02634320 (6) [back to overview]Change From Baseline to Last Treatment Visit in Clinical Global Impressions-Severity (CGI-S) Scores
NCT02634320 (6) [back to overview]Characterization of Family Burden Will be Measured Using the Burden Assessment Scale (BAS)
NCT02634320 (6) [back to overview]Daily and Social Functioning Will be Measured Using the Heinrichs-Carpenter Quality of Life Scale (QLS)
NCT02634320 (6) [back to overview]Number of Participants With Adverse Events
NCT02634320 (6) [back to overview]Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6)
NCT03345979 (7) [back to overview]Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
NCT03345979 (7) [back to overview]Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25
NCT03345979 (7) [back to overview]Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9
NCT03345979 (7) [back to overview]Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25
NCT03345979 (7) [back to overview]Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4
NCT03345979 (7) [back to overview]Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9
NCT03345979 (7) [back to overview]Number of Participants With Serious and Non-serious Adverse Events (AEs)
NCT04203056 (3) [back to overview]"Change From Baseline to One-Year in the MATRICS Consensus Cognitive Battery (MCCB) Overall Composite T-Score."
NCT04203056 (3) [back to overview]Change in Role Ratings on the Global Functioning Scale From Baseline to 12 Months
NCT04203056 (3) [back to overview]Exacerbation or Relapse of Psychotic Symptoms

Change From Baseline to Last Treatment Visit in Brief Psychiatric Rating Scale (BPRS) Scores

The BPRS is an instrument for evaluating change in psychopathology in patients with schizophrenia. It consists of 18 items in which clinicians rate patient symptoms on a 7-point scale (1=not present, 7=extremely severe). Scores range from 18 to 126, with higher scores indicative of more severe psychopathology). (NCT02634320)
Timeframe: Up to 7 months

Interventionunits on a scale (Mean)
Aripiprazole Lauroxil-2.7

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Change From Baseline to Last Treatment Visit in Clinical Global Impressions-Severity (CGI-S) Scores

"The CGI-S is a 7-point scale that requires the clinician to assess how mentally ill the patient is in a specific point in time. Results indicate participants evaluated at one of the following categories: 1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; and 7: among the most extremely ill patients. Results indicate a change in CGI-S score from baseline to last visit in the treatment period based on the observed data." (NCT02634320)
Timeframe: Up to 7 months

Interventionunits on a scale (Mean)
Aripiprazole Lauroxil-0.2

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Characterization of Family Burden Will be Measured Using the Burden Assessment Scale (BAS)

"The BAS is a 19-item scale completed by the caregiver that focuses on specific subjective and objective consequences of families caring for individuals with severe mental disorders. Respondents are required to indicate whether they have experienced each of the types of burden - 'Not at all', 'A little', 'Some' or A lot' - in the previous four weeks. These are scored 1, 2, 3 and 4, respectively. The total score ranges between 19 and 76. A higher score indicates more perceived burden. Subjects required a reliable informant (caregiver) in order to participate in the study. These caregivers did not receive study treatment, and they are not represented elsewhere in the results data. The data provided indicates the change from baseline to the last treatment visit." (NCT02634320)
Timeframe: Up to 7 months

Interventionunits on a scale (Mean)
Aripiprazole Lauroxil-3.2

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Daily and Social Functioning Will be Measured Using the Heinrichs-Carpenter Quality of Life Scale (QLS)

The QLS is a clinician-rated scale that is used to assess health-related quality of life and functioning in patients with schizoprehnia during the preceding 4 weeks. The QLS consists of 21 items in 4 major domains (Intrapsychic Foundations, Interpersonal Relations, Instrumental Role, and Common Objects and Activities). Following a semi-structured interview, each item is rated on a 7-point scale, from 0 (severe impairment) to 6 (normal or unimpaired functioning). (NCT02634320)
Timeframe: Up to 7 months

Interventionunits on a scale (Mean)
Aripiprazole Lauroxil0.4

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Number of Participants With Adverse Events

(NCT02634320)
Timeframe: Up to 7 months

InterventionParticipants (Count of Participants)
Aripiprazole Lauroxil21

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Characterization of Healthcare Burden Will be Measured Using the Treatment Services Review, Version 6-Modified for Mental Health (mTSR-6)

Responses to 4 mTSR-6 questions have been provided. Results include the number of participants who responded positively to the category during the entire post-baseline treatment period. (NCT02634320)
Timeframe: Up to 7 months

Interventionparticipants (Number)
Spent at least 1 overnight as an inpatientAttended an outpatient visit for mental healthHad at least 1 visit to an ERWere arrested, picked up, or transported by police
Aripiprazole Lauroxil31762

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Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4

Change within treatment groups of Positive and Negative Syndrome Scale (PANSS) total score between baseline and week 4 based on the observed data without imputation for missing data. The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition. (NCT03345979)
Timeframe: Baseline and 4 weeks

Interventionunits on a scale (Mean)
Aripiprazole Lauroxil-17.4
Paliperidone Palmitate-20.1

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Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25

Change within treatment groups at baseline Positive and Negative Syndrome Scale (PANSS) and at 25 weeks based on the observed data without imputation for missing data. The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition (NCT03345979)
Timeframe: Baseline and 25 weeks

Interventionunits on a scale (Mean)
Aripiprazole Lauroxil-23.3
Paliperidone Palmitate-21.7

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Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9

Change within treatment groups from baseline Positive and Negative Syndrome Scale (PANSS) and 9 weeks based on the observed data without imputation for missing data. The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition. (NCT03345979)
Timeframe: Baseline and 9 weeks

Interventionunits on a scale (Mean)
Aripiprazole Lauroxil-19.8
Paliperidone Palmitate-22.5

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Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 25

Least squares mean change in Positive and Negative Syndrome Scale (PANSS) total score at week 25 from Mixed Models Repeated Measures. The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition (NCT03345979)
Timeframe: Baseline and 25 weeks

Interventionunits on a scale (Least Squares Mean)
Aripiprazole Lauroxil-22.0
Paliperidone Palmitate-21.1

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Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4

Least squares mean change in Positive and Negative Syndrome Scale (PANSS) between at 4 weeks from Mixed Models Repeated Measures (MMRM). The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition (NCT03345979)
Timeframe: Baseline and 4 weeks

Interventionunits on a scale (Least Squares Mean)
Aripiprazole Lauroxil-17.3
Paliperidone Palmitate-19.3

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Least Squares Mean Change in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 9

Least squares mean change from baseline Positive and Negative Syndrome Scale (PANSS) and 9 weeks from Mixed Models Repeated Measures (MMRM).The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition (NCT03345979)
Timeframe: Baseline and 9 weeks

Interventionunits on a scale (Least Squares Mean)
Aripiprazole Lauroxil-18.8
Paliperidone Palmitate-21.5

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Number of Participants With Serious and Non-serious Adverse Events (AEs)

(NCT03345979)
Timeframe: Up to 25 weeks

InterventionParticipants (Count of Participants)
Aripiprazole Lauroxil69
Paliperidone Palmitate72

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"Change From Baseline to One-Year in the MATRICS Consensus Cognitive Battery (MCCB) Overall Composite T-Score."

"The change from Baseline to One-year on the MATRICS Consensus Cognitive Battery Overall Composite score. MATRICS is the abbreviation for Measurement and Treatment Research to Improve Cognition in Schizophrenia. T scores do not have an absolute minimum or maximum. Higher scores represent better cognition. The sex and age adjusted T-score was used. The T-Score has a population mean of 50 and standard deviation of 10.~Fewer subjects analyzed than enrolled because only 9 subjects reached the 12 month point by study discontinuation and had MCCB data." (NCT04203056)
Timeframe: 12 months

InterventionChange score: change in T scores (Mean)
AL-LAI: Long-Acting Injectable Antipsychotic9.3
ARI-ORAL: Aripiprazole Oral Antipsychotic4.6

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Change in Role Ratings on the Global Functioning Scale From Baseline to 12 Months

The groups will be compared on change in this measure of role functioning. Scores range from 1 to 10, with higher indicating better role functioning. Change scores can theoretically range from 0 to 9 (NCT04203056)
Timeframe: mean change from baseline to the 12 month point

Interventionscore on a scale (Mean)
AL-LAI: Long-Acting Injectable Antipsychotic4.3
ARI-ORAL: Aripiprazole Oral Antipsychotic.06

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Exacerbation or Relapse of Psychotic Symptoms

Number of participants who experienced an exacerbation and/or relapse following a period of absence or relative low levels of psychotic symptoms based on the expanded 24-item version of the Brief Psychiatric Rating Scale (NCT04203056)
Timeframe: 12 months

InterventionParticipants (Count of Participants)
AL-LAI: Long-Acting Injectable Antipsychotic2
ARI-ORAL: Aripiprazole Oral Antipsychotic2

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