CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 17 enrolled
Drug / intervention
OPC-14597 IMDdrug
Likely dose
OPC-14597 IMD 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/NCT02220712
NCT02220712Phase 1Completed
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A Multicenter Open-label Study Investigating the Pharmacokinetics and Safety of Aripiprazole IM Depot Formulation (OPC-14597 IMD) During Repeated Administration by Injection Into the Deltoid Muscle in Patients With Schizophrenia

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Aug 20, 2014·Updated Jan 25, 2021

In Brief

A Phase 1 clinical trial evaluating OPC-14597 IMD for Schizophrenia. Completed, enrolled 17 participants across 5 sites.

Detailed Summary

To assess the pharmacokinetics and safety of aripiprazole intra-muscular (IM) depot formulation in patients with schizophrenia after repeated administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesJapan
Collaborators--

Timeline

Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 20, 2014
Enrollment StartJul 1, 2014
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 11.9 years ago

Interventions

OPC-14597 IMDdrug

Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals