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NCT01412060 · ClinicalTrials.gov registry record · Phase 3
A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia
A Phase 3 study of Schizophrenia, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 765
- Enrollment target
- 20
- Study locations
NCT01412060: Completed Phase 3 study of Schizophrenia, sponsored by Forest Laboratories.
NCT01412060 is a Phase 3 study of Schizophrenia that has completed, run by Forest Laboratories. The registered enrollment target is 765 participants, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (253% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01412060, a Phase 3 study of Schizophrenia, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 765 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this study is to evaluate the efficacy and safety of cariprazine relative to placebo in the prevention of relapse of symptoms in participants with schizophrenia.
Primary Outcome
Relapse was defined as meeting ≥1 of the following criteria:1-Hospitalization due to worsening of condition;2-increase in Positive and Negative Syndrome Scale(PANSS) total score by ≥30% for participants,scored ≥50 or a ≥10-point increase for participants,scored \<50 at randomization;3-increase in Clinical Global Impressions-Severity(CGI-S) score by ≥2 points at Week 20;4-deliberate self-injury or aggressive behaviour;5-suicidal/homicidal ideation judged clinically significant by Investigator;6-s
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Cariprazine
Study Locations (20)
California
- Forest Investigative Site 018 - Cerritos
- Forest Investigative Site 007 - Costa Mesa
- Forest Investigative Site 026 - Culver City
- Forest Investigative Site 008 - Long Beach
- Forest Investigative Site 002 - Oceanside
- Forest Investigative Site 019 - Orange
- Forest Investigative Site 001 - Paramount
- Forest Investigative Site 020 - San Diego
Maryland
- Forest Investigative Site 023 - Baltimore
- Forest Investigative Site 010 - Rockville
Missouri
- Forest Investigative Site 006 - Creve Coeur
- Forest Investigative Site 014 - St Louis
Arkansas
- Forest Investigative Site 011 - Little Rock
District of Columbia
- Forest Investigative Site 005 - Washington D.C.
Florida
- Forest Investigative Site 024 - Leesburg
Georgia
- Forest Investigative Site 017 - Atlanta
Illinois
- Forest Investigative Site 021 - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 765 participants |
| Start Date | 2011-09-27 |
| Est. Completion | 2014-09-03 |
| Phase | Phase 3 |
What the finished NCT01412060 record still lists
NCT01412060 is an interventional study that assigns participants to a tested intervention. The registered 765 participants enrollment target is mid-sized for trials with a published cap, above the 217-participant average among 315 other Schizophrenia trials with a reported enrollment target (253% higher).
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01412060 names 20 study sites across 11 states, led by California, Maryland, Missouri.
Frequently Asked Questions
What is clinical trial NCT01412060 about?
NCT01412060 is a clinical study titled "A Study of Cariprazine in the Prevention of Relapse of Symptoms in Participants With Schizophrenia". The objective of this study is to evaluate the efficacy and safety of cariprazine relative to placebo in the prevention of relapse of symptoms in participants with schizophrenia.
What is the current status of trial NCT01412060?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 765 participants. The study started on 2011-09-27. Estimated completion is 2014-09-03.
What conditions does trial NCT01412060 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT01412060?
The interventions under investigation include: Placebo (DRUG), Cariprazine (DRUG).
Who is sponsoring clinical trial NCT01412060?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01412060 being conducted?
This trial has 20 study locations across Arkansas, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Schizophrenia
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 NCT01412060's enrollment target sits among peer trials
765 16th of 315 higher than 300 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia 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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