Completed PHASE4 INTERVENTIONAL 2-arm NCT00277212

A Phase IV Study of the Safety and Efficacy of Aripiprazole in Combination With Lamotrigine in the Long-Term Maintenance Treatment of Patients With Bipolar I Disorder With A Recent Manic or Mixed Episode

A Multicenter, Double-blind, Study of the Efficacy and Safety of Aripiprazole in Combination With Lamotrigine in the Long-term Maintenance Treatment of Patients With Bipolar I Disorder With a Recent Manic or Mixed Episode

Sponsor: Otsuka America Pharmaceutical

Conditions Bipolar Disorder

Interventions Lamotrigine + Aripiprazole Lamotrigine + Placebo

Updated 7 times since 2017 Last updated: Nov 7, 2013 Started: Dec 31, 2005 Primary completion: Jul 31, 2009 Completion: Jul 31, 2009

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

This PHASE4 trial investigates Bipolar Disorder and is currently completed. Otsuka America Pharmaceutical leads this study, which shows 7 recorded versions since 2005 — indicating limited longitudinal coverage. This study adds to the longitudinal dataset for psychiatric treatment development.

Status Flow

Change History

7 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE4
Sep 2024 — Sep 2025 [monthly]

Completed PHASE4
Jul 2024 — Sep 2024 [monthly]

Completed PHASE4
Jan 2021 — Jul 2024 [monthly]

Completed PHASE4
Jun 2018 — Jan 2021 [monthly]

Completed PHASE4

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE4
Jan 2017 — Feb 2017 [monthly]

Completed PHASE4

First recorded

Dec 2005

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Otsuka America Pharmaceutical
Otsuka Pharmaceutical Development & Commercialization, Inc.

Data source: Otsuka Pharmaceutical Development & Commercialization, Inc.

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

Study Locations

Allentown, United States , Anaheim, United States , Atlanta, United States , Baltimore, United States , Birmingham, United States , Bismarck, United States , Boca Raton, United States , Bothell, United States , Buffalo, United States , Cabo Rojo, Puerto Rico and 52 more locations