Study to Evaluate the Efficacy and Safety of Aripiprazole Administered With Lithium or Valproate Over 12 Weeks in the Treatment of Mania in Bipolar I Disorder
A 12-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate the Efficacy and Safety of Adjunctive Aripiprazole Therapy in the Treatment of Mania in Bipolar I Disorder Patients Treated on Valproate or Lithium and in Need of Further Clinical Improvement
Sponsor: Otsuka America Pharmaceutical
Listed as NCT00665366, this PHASE3 trial focuses on Bipolar Disorder Mania and remains completed. Sponsored by Otsuka America Pharmaceutical, it has been updated 7 times since 2008, reflecting limited change activity. Mental health research at this phase helps define safety and dosing parameters for future study.
Status Flow
Change History
7 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE3
-
Jun 2018 — Jan 2021 [monthly]
Completed PHASE3
▶ Show 2 earlier versions
-
Feb 2017 — Jun 2018 [monthly]
Completed PHASE3
-
Jan 2017 — Feb 2017 [monthly]
Completed PHASE3
First recorded
Jun 2008
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Otsuka America Pharmaceutical
- Otsuka Pharmaceutical Development & Commercialization, Inc.
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Ankara, Turkey (Türkiye) , Antalya, Turkey (Türkiye) , Athens, Greece , Barcelona, Spain , Beaupuy, France , Brumath, France , Bucharest, Romania , Budapest, Hungary , Campobasso, Italy , Cape Town, South Africa and 55 more locations