Completed PHASE4 INTERVENTIONAL 2-arm NCT00261443

A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania

Efficacy of Aripiprazole in Combination With Lithium or Valproate in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients Partially Nonresponsive to Lithium or Valproate Monotherapy

Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Conditions Bipolar Disorder

Interventions Lithium or Valproate with Aripiprazole Lithium or Valproate with placebo (PBO)

Updated 8 times since 2017 Last updated: Mar 22, 2023 Started: Sep 30, 2005 Primary completion: Jun 30, 2009 Completion: Oct 31, 2009

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

Listed as NCT00261443, this PHASE4 trial focuses on Bipolar Disorder and remains completed. Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc., it has been updated 8 times since 2005, reflecting limited change activity. Mental health research at this phase helps define safety and dosing parameters for future study.

Status Flow

Change History

8 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE4
Sep 2024 — Sep 2025 [monthly]

Completed PHASE4
Jul 2024 — Sep 2024 [monthly]

Completed PHASE4
May 2023 — Jul 2024 [monthly]

Completed PHASE4
Jan 2021 — May 2023 [monthly]

Completed PHASE4

▶ Show 3 earlier versions

Jun 2018 — Jan 2021 [monthly]

Completed PHASE4
Feb 2017 — Jun 2018 [monthly]

Completed PHASE4
Jan 2017 — Feb 2017 [monthly]

Completed PHASE4

First recorded

Sep 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

Ahmedabad, India , Anaheim, United States , Aparecida de Goinia, Brazil , Austin, United States , Beachwood, United States , Bellevue, United States , Berea, South Africa , Brno, Czechia , Burgas, Bulgaria , Cape Town, South Africa and 61 more locations