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NCT01104766 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Cariprazine in Patients With Schizophrenia
A Phase 3 study, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 617
- Enrollment target
NCT01104766: Completed Phase 3 study, sponsored by Forest Laboratories.
NCT01104766 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 617 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01104766, a Phase 3 study, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 617 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.
Primary Outcome
The Positive and Negative Syndrome Scale is a 30-item rating scale specifically developed to asses both the positive and negative symptom syndromes of patients with schizophrenia. The PANSS total score is rated based on a structured clinical interview with the patient and supporting clinical information obtained from family, hospital staff, or other reliable informants. This assessment provides scores in 9 clinical domains, including a positive syndrome, a negative syndrome, depression, a compos
Interventions
- DRUG Placebo
- DRUG Cariprazine
- DRUG Aripiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 617 participants |
| Start Date | 2010-04-23 |
| Est. Completion | 2011-12-20 |
| Phase | Phase 3 |
What the finished NCT01104766 record still lists
NCT01104766 is an interventional study that assigns participants to a tested intervention. The registered 617 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01104766 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01104766 about?
NCT01104766 is a clinical study titled "Safety and Efficacy of Cariprazine in Patients With Schizophrenia". The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine relative to placebo for the treatment of acute exacerbation of schizophrenia.
What is the current status of trial NCT01104766?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 617 participants. The study started on 2010-04-23. Estimated completion is 2011-12-20.
What interventions are being tested in trial NCT01104766?
The interventions under investigation include: Placebo (DRUG), Cariprazine (DRUG), Aripiprazole (DRUG).
Who is sponsoring clinical trial NCT01104766?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01104766's enrollment target sits among peer trials
617 592nd of 2000 higher than 1,408 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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