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NCT01059539 · ClinicalTrials.gov registry record · Phase 3
Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder
A Phase 3 study of Bipolar I Disorder, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 403
- Enrollment target
- 20
- Study locations
NCT01059539: Completed Phase 3 study of Bipolar I Disorder, sponsored by Forest Laboratories.
NCT01059539 is a Phase 3 study of Bipolar I Disorder that has completed, run by Forest Laboratories. The registered enrollment target is 403 participants, above the 314-participant average among 26 other Bipolar I Disorder trials with a reported enrollment target (28% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01059539, a Phase 3 study of Bipolar I Disorder, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 403 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.
Primary Outcome
The Young Mania Rating Scale (YMRS) is an 11-item scale that assesses manic symptoms based on the patient's perception of his or her condition over the previous 48 hours, as well as the physician's clinical observations during the interview. The 11 items are elevated mood, increased motor activity-energy, sexual interest, sleep, irritability, rate and amount of speech, language-thought disorder, content, disruptive-aggressive behavior, appearance, and insight. The severity of each item is rated
Conditions Studied
Interventions
- DRUG Cariprazine
Study Locations (20)
California
- Forest Investigative Site 010 - Carson
- Forest Investigative Site 020 - Cerritos
- Forest Investigative Site 009 - Escondido
- Forest Investigative Site 004 - Garden Grove
- Forest Investigative Site 016 - San Diego
- Forest Investigative Site 007 - Santa Ana
Florida
- Forest Investigative Site 001 - Bradenton
- Forest Investigative Site 006 - Fort Lauderdale
- Forest Investigative Site 013 - Kissimmee
Missouri
- Forest Investigative Site 022 - Creve Coeur
- Forest Investigative Site 003 - Saint Charles
- Forest Investigative Site 025 - St Louis
Arkansas
- Forest Investigative Site 015 - Springdale
District of Columbia
- Forest Investigative Site 023 - Washington D.C.
Maryland
- Forest Investigative Site 021 - Rockville
Mississippi
- Forest Investigative Site 024 - Flowood
Nevada
- Forest Investigative Site 012 - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 403 participants |
| Start Date | 2010-02-28 |
| Est. Completion | 2012-02-29 |
| Phase | Phase 3 |
What the finished NCT01059539 record still lists
NCT01059539 is an interventional study that assigns participants to a tested intervention. The registered 403 participants enrollment target is mid-sized for trials with a published cap, above the 314-participant average among 26 other Bipolar I Disorder trials with a reported enrollment target (28% higher).
The record links to 1 condition, with Bipolar I Disorder appearing as the primary indexed condition, and to 1 intervention - of which Cariprazine is the first listed.
NCT01059539 names 20 study sites across 11 states, led by California, Florida, Missouri.
Frequently Asked Questions
What is clinical trial NCT01059539 about?
NCT01059539 is a clinical study titled "Long-term Safety and Tolerability of Cariprazine for Bipolar I Disorder". The objective of this study is to evaluate the long-term safety, tolerability, and pharmacokinetics of cariprazine in patients with bipolar I disorder.
What is the current status of trial NCT01059539?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 403 participants. The study started on 2010-02-28. Estimated completion is 2012-02-29.
What conditions does trial NCT01059539 study?
This clinical trial studies the following conditions: Bipolar I Disorder.
What interventions are being tested in trial NCT01059539?
The interventions under investigation include: Cariprazine (DRUG).
Who is sponsoring clinical trial NCT01059539?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01059539 being conducted?
This trial has 20 study locations across Arkansas, California, District of Columbia, Florida, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar I Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01059539's enrollment target sits among peer trials
403 4th of 26 higher than 23 of 26 other Bipolar I Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar I Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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