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Aripiprazole Lauroxil

DRUG6 trials

Sponsors

Alkermes, Inc., University of California, Los Angeles, University of Miami

Conditions

Schizoaffective DisorderSchizoaffective Disorder, Depressive TypeSchizophreniaSchizophreniform Disorder

Phase 1

An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia
CompletedNCT02320032
Alkermes, Inc.Schizophrenia
Start: 2014-12-31End: 2016-04-30Updated: 2018-08-29
A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder
CompletedNCT02636842
Alkermes, Inc.Schizoaffective Disorder, Schizophrenia
Start: 2015-12-31End: 2016-06-30Updated: 2016-07-14

Phase 3

A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia
CompletedNCT03345979
Alkermes, Inc.Schizophrenia
Start: 2017-11-15End: 2019-03-12Updated: 2020-08-11

Phase 4

A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia
CompletedNCT02634320
Alkermes, Inc.Schizophrenia
Start: 2015-12-31End: 2017-07-11Updated: 2018-12-04
Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode
TerminatedNCT04203056
University of California, Los AngelesSchizoaffective Disorder, Depressive Type, Schizophrenia, Schizophreniform Disorder
Start: 2019-12-16End: 2022-10-01Updated: 2023-11-28
C-Cog in Early Course Schizophrenia Study
TerminatedNCT05662306
University of MiamiSchizophrenia
Start: 2024-01-23End: 2025-03-03Updated: 2026-02-06

Related Papers

Aripiprazole Lauroxil Every 2 Months or Paliperidone Palmitate Monthly for Acute Schizophrenia: A Post Hoc Analysis of PANSS Five-Factor Scores in the ALPINE Trial.
2025-05-14
Aripiprazole Lauroxil Every 2 Months for the Treatment of Adults With Schizophrenia: A Post Hoc Analysis of Efficacy by Baseline Severity of Illness From Phase 3b Clinical Trial Data
Schizophrenia Bulletin Open2025-01-01
Initiating Aripiprazole Lauroxil
The Journal of Clinical Psychiatry2024-08-111 citations
Safety and Tolerability of Starting Aripiprazole Lauroxil With Aripiprazole Lauroxil NanoCrystal Dispersion in 1 Day Followed by Aripiprazole Lauroxil Every 2 Months Using Paliperidone Palmitate Monthly as an Active Control in Patients With Schizophrenia
The Journal of Clinical Psychiatry2024-02-263 citations
Comment on “Aripiprazole Plasma Concentrations Delivered from Two 2-Month Long-Acting Injectable Formulations: An Indirect Comparison” [Letter]
Neuropsychiatric Disease and Treatment2023-07-01
Aripiprazole lauroxil 2-month formulation with 1-day initiation in patients hospitalized for an acute exacerbation of schizophrenia: exploratory efficacy and patient-reported outcomes in the randomized controlled ALPINE study.
2021-10-0810 citations
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.
2020-09-0115 citations
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
The Journal of Clinical Psychiatry2020-05-1819 citations
Pharmacokinetic Profile of a 2-Month Dose Regimen of Aripiprazole Lauroxil: A Phase I Study and a Population Pharmacokinetic Model
CNS Drugs2017-06-0842 citations