CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 106 enrolled
Drug / intervention
Aripiprazole Low (2 mg/day) +2 moredrug
Likely dose
Aripiprazole Low (2 mg/day)from 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/NCT01942161
NCT01942161Phase 3Completed
CompareCT.gov

A Multicenter, Double-blind, Randomized, Dose-comparison Study of Three Different Doses of Aripiprazole (2 mg/Day, 6-12 mg/Day, 24-30 mg/Day) Orally Administered Over 6 Weeks in Pediatric Patients (Aged 13-17 Years) With Schizophrenia

Otsuka Pharmaceutical Co., Ltd.·interventional·Posted Sep 13, 2013·Updated Jun 28, 2017

In Brief

A Phase 3 clinical trial evaluating Aripiprazole Low (2 mg/day), Aripiprazole Mid (6 - 12 mg/day), and 1 other intervention for Schizophrenia. Completed, enrolled 106 participants across 8 sites.

Detailed Summary

The objective of this study is to investigate the efficacy and safety of three different doses of aripiprazole (2 mg/day, 6-12 mg/day, 24-30 mg/day) orally administered over a period of 6 weeks in pediatric patients (aged 13-17 years) with schizophrenia

Study Details

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

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 13, 2013
Enrollment StartAug 1, 2010
Primary CompletionNov 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 12.8 years ago

Interventions

Aripiprazole Low (2 mg/day)drug

administered 2 mg once daily for 6 weeks

Aripiprazole Mid (6 - 12 mg/day)drug

administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg

Aripiprazole High (24 - 30 mg/day)drug

administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg