Completed PHASE3 INTERVENTIONAL 3-arm NCT00110461

Aripiprazole in Children and Adolescents With Bipolar I Disorder

A Phase III Trial to Test the Safety and Efficacy of Two Doses of Aripiprazole in Child and Adolescent Patients With Bipolar I Disorder, Manic or Mixed Episode With or Without Psychotic Features

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Conditions Bipolar Disorder

Interventions Aripiprazole placebo

Updated 10 times since 2017 Last updated: Apr 19, 2012 Started: Mar 31, 2005 Primary completion: Feb 28, 2007 Completion: Feb 28, 2007

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Bipolar Disorder, this trial is completed. The trial is conducted by Otsuka Pharmaceutical Development & Commercialization, Inc. and has accumulated 10 data snapshots since 2005. Psychiatric clinical trials are essential for establishing evidence-based treatment standards.

Status Flow

Change History

10 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2023 — Jul 2024 [monthly]

Completed PHASE3
Dec 2022 — Jan 2023 [monthly]

Completed PHASE3

▶ Show 5 earlier versions

Dec 2021 — Dec 2022 [monthly]

Completed PHASE3
Jan 2021 — Dec 2021 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Mar 2005

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Otsuka Pharmaceutical Development & Commercialization, Inc.

Data source: Otsuka Pharmaceutical Development & Commercialization, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Altamonte Springs, United States , Atlanta, United States , Baton Rouge, United States , Bellaire, United States , Boise, United States , Cambridge, United States , Charleston, United States , Chicago, United States , Cincinnati, United States , Cleveland, United States and 42 more locations