CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 493 enrolled
Drug / intervention
Aripiprazole (Abilify®) IM Depot Injectiondrug
Likely dose
Aripiprazole (Abilify®) IM Depot Injection 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/NCT01432444
NCT01432444Phase 3Completed
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Open-label Study to Assess Hospitalization Rates in Adult Schizophrenic Patients Treated With Oral Antipsychotics for 6 Months and IM Depot Aripiprazole for 6 Months, Respectively, in a Naturalistic Community Setting

Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Sep 13, 2011·Updated May 7, 2015

In Brief

A Phase 3 clinical trial evaluating Aripiprazole (Abilify®) IM Depot Injection for Schizophrenia. Completed, enrolled 493 participants across 124 sites in 2 countries.

Detailed Summary

The purpose of this study is to compare retrospective hospitalization rates of schizophrenic patients treated with oral antipsychotics to prospective hospitalization rates of these patients treated with IM depot aripiprazole.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesCanada, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 13, 2011
Enrollment StartSep 1, 2011
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.8 years ago

Interventions

Aripiprazole (Abilify®) IM Depot Injectiondrug

400 mg IM depot injection every 26-30 days. Dosage may be adjusted at the investigator's discretion to 300 mg. Number of injections: 6. Subjects have the option of entering the extension phase of the study and continuing with injections every 26-30 days until the drug is either commercially available, or December 2013.