At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 141 enrolled
Drug / intervention
Aripiprazole, OPC-14597drug
Likely dose
Aripiprazole, OPC-14597 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.
An Open-label, Multiple Dose, Safety and Tolerability Study of Aripiprazole IM Depot Administered in the Deltoid Muscle in Adult Subjects With Schizophrenia
Otsuka Pharmaceutical Development & Commercialization, Inc.·interventional·Posted Jul 26, 2013·Updated Jul 1, 2015
In Brief
A Phase 1 clinical trial evaluating Aripiprazole, OPC-14597 for Schizophrenia and 2 related conditions. Completed, enrolled 141 participants across 11 sites.
Detailed Summary
To determine the safety and tolerability of multiple-dose administrations of aripiprazole intramuscular (IM) depot in the deltoid muscle in adult subjects with schizophrenia
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia, Mental Disorder, Nervous System Diseases
CountriesUnited States
CollaboratorsH. Lundbeck A/S
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJul 2013
First PostedJul 2013
Primary CompletionMar 2014
Study CompletionApr 2014
TodayJul 2026
First PostedJul 26, 2013
Enrollment StartJul 1, 2013
Primary CompletionMar 1, 2014
Study CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 12.9 years ago
Interventions
Aripiprazole, OPC-14597drug
5 monthly applications of 400 mg of aripiprazole IM depot, where the first application is in the gluteal or deltoid muscle followed by 4 monthly administrations to the deltoid muscle