Completed PHASE3 INTERVENTIONAL 2-arm NCT01058096

Safety and Efficacy of Cariprazine for Mania

A Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of Cariprazine in Patients With Acute Mania Associated With Bipolar I Disorder

Sponsor: Forest Laboratories

Conditions Bipolar Disorder Mania

Interventions Cariprazine Placebo

Updated 9 times since 2017 Last updated: Mar 1, 2017 Started: Feb 28, 2010 Primary completion: Jul 31, 2011 Completion: Jul 31, 2011

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

Listed as NCT01058096, this PHASE3 trial focuses on Bipolar Disorder and Mania and remains completed. Sponsored by Forest Laboratories, it has been updated 9 times since 2010, reflecting limited change activity. Mental health research at this phase helps define safety and dosing parameters for future study.

Status Flow

Change History

9 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Dec 2021 — Jul 2024 [monthly]

Completed PHASE3
Jan 2021 — Dec 2021 [monthly]

Completed PHASE3

▶ Show 4 earlier versions

Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Jun 2017 — Jun 2018 [monthly]

Completed PHASE3
Feb 2017 — Jun 2017 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Feb 2010

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Forest Laboratories
Gedeon Richter Ltd.

Data source: Forest Laboratories

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

Study Locations

Ahmedabad, India , Aurangabad, India , Bangalore, India , Chennai, India , Chicago, United States , Cleveland, United States , Creve Couer, United States , Flowood, United States , Houston, United States , Kanpur, India and 14 more locations