CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 937 enrolled / 937 target
Drug / intervention
Aripiprazole depot 300 or 400 mg +4 moredrug
Likely dose
Aripiprazole depot 300 or 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00706654
NCT00706654Phase 3CompletedMonitor (4.4/mo)Completion was 166mo ago
CompareCT.gov

A 38-week, Multicenter, Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of an Intramuscular Depot Formulation of Aripiprazole (OPC-14597) as Maintenance Treatment in Patients With Schizophrenia

Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Jun 27, 2008·Updated Jun 4, 2026

In Brief

A Phase 3 clinical trial evaluating Aripiprazole depot 300 or 400 mg, Aripiprazole 10-30 mg orally, and 3 other interventions for Schizophrenia. Completed, enrolled 937 participants across 98 sites in 15 countries.

Signals

Enrolling slower than its timeline implies

Detailed Summary

The purpose of the this trial is to evaluate the efficacy, safety, and tolerability of an intramuscular (IM) depot formulation of aripiprazole as maintenance treatment in patients with schizophrenia The trial is designed into three treatment phases. Phase 1 is designed to allow for a subject to be converted from the current anti-psychotic treatment to oral non-generic aripiprazole monotherapy (oral conversion phase from 4 to 6 weeks). During Phase 2 the subject will be stabilized on oral non-generic aripiprazole monotherapy. Once the subject is stabilized in Phase 2 (oral stabilization phase from minimum 8 weeks to maximum 28 weeks), they are eligible to be randomized into the double-blind IM depot maintenance phase, Phase 3. During Phase 3, the subject will be assessed for exacerbation of psychotic symptoms and impending relapse for up to 38 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesAustria, Belgium, Bulgaria, Chile, Croatia, Estonia, France, Hungary, Italy, Poland, Puerto Rico, South Africa, South Korea, Thailand, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 27, 2008
Enrollment StartSep 1, 2008
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 18.0 years ago

Arms & Interventions

Aripiprazole depot 300 or 400 mgexperimental

Patients received aripiprazole 300 mg or 400 mg depot intramuscularly every 28 days for 38 weeks.

Drug: Aripiprazole depot 300 or 400 mgDrug: Placebo tablets
Aripiprazole 10-30 mg orallyactive_comparator

Patients received aripiprazole 10-30 mg orally daily for 38 weeks.

Drug: Aripiprazole 10-30 mg orallyDrug: Placebo depot
Aripiprazole depot 25 or 50 mgexperimental

Patients received aripiprazole 25 mg or 50 mg depot intramuscularly every 28 days for 38 weeks.

Drug: Aripiprazole depot 25 or 50 mgDrug: Placebo tablets

Interventions

Aripiprazole depot 300 or 400 mgdrug

Aripiprazole depot was supplied in 400 mg lyophilized vials. Patients received aripiprazole 300 mg if they were unable to tolerate aripiprazole 400 mg.

Aripiprazole 10-30 mg orallydrug

Aripiprazole was supplied as 10, 15, and 20 mg tablets. The dose that the patient received was based on the investigator's judgment and the subject's clinical need.

Aripiprazole depot 25 or 50 mgdrug

Aripiprazole depot was supplied in 200 mg lyophilized vials. Patients received aripiprazole 25 mg if they were unable to tolerate aripiprazole 50 mg.

Placebo depotdrug

Placebo depot was supplied in lyophilized vials.

Placebo tabletsdrug

Placebo tablets were identical in appearance to the aripiprazole tablets.