Safety and Efficacy of Cariprazine for Mania
Public ClinicalTrials.gov record NCT01058096. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double-Blind, Placebo-Controlled, Evaluation of the Safety and Efficacy of Cariprazine in Patients With Acute Mania Associated With Bipolar I Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.
Study identification
- NCT ID
- NCT01058096
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 323 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2010 (Type not available)
- Primary completion
- Jul 2011 (Actual)
- Completion
- Jul 2011 (Actual)
- Last update posted
- Apr 17, 2017
2010 – 2011
United States locations
- U.S. sites
- 10
- U.S. states
- 8
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Forest Investigative Site 004 | Long Beach | California | 90813 | — |
| Forest Investigative Site 005 | Riverside | California | 92506 | — |
| Forest Investigative Site 007 | San Diego | California | 92123 | — |
| Forest Investigative Site 009 | Chicago | Illinois | 60640 | — |
| Forest Investigative Site 006 | Lake Charles | Louisiana | 70601 | — |
| Forest Investigative Site 001 | Flowood | Mississippi | 39232 | — |
| Forest Investigative Site 003 | Creve Couer | Missouri | 63141 | — |
| Forest Investigative Site 008 | Cleveland | Ohio | 44109 | — |
| Forest Investigative Site 010 | Oklahoma City | Oklahoma | 73116 | — |
| Forest Investigative Site 002 | Houston | Texas | 77008 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 18 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01058096, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 17, 2017 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01058096 live on ClinicalTrials.gov.