At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 41 enrolled
Drug / intervention
aripiprazole IM depot +1 moredrug
Likely dose
aripiprazole IM depot 200 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.
An Open-label Parallel Arm Multiple Dose Tolerability, Pharmacokinetics and Safety Study in Adult Patients With Schizophrenia Following Administration of Aripiprazole IM Depot Formulation Once Every Four Weeks
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Jun 6, 2013·Updated Jan 22, 2014
In Brief
A Phase 1 clinical trial evaluating aripiprazole IM depot and aripiprazole tablets for Schizophrenia. Completed, enrolled 41 participants across 7 sites.
Detailed Summary
This study will evaluate the safety, tolerability, efficacy and pharmacokinetics of aripiprazole intramuscular (IM) depot multiple doses every 4 weeks in adult patients with schizophrenia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2007
Primary CompletionOct 2008
First PostedJun 2013
TodayJul 2026
First PostedJun 6, 2013
Enrollment StartNov 1, 2007
Primary CompletionOct 1, 2008
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.1 years ago
Interventions
aripiprazole IM depotdrug
Aripiprazole IM depot supplied as 200 mg or 400 mg vials of lyophilized aripiprazole powder to prepare for IM injection.
aripiprazole tabletsdrug
Aripiprazole tablets 10 mg once daily in the morning for 14 days.