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NCT01104779 · ClinicalTrials.gov registry record · Phase 3

Safety and Efficacy of Cariprazine in Schizophrenia

A Phase 3 study, sponsored by Forest Laboratories.

Completed
Registry status
Phase 3
Development phase
446
Enrollment target

NCT01104779: Completed Phase 3 study, sponsored by Forest Laboratories.

NCT01104779 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 446 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01104779, a Phase 3 study, has completed, sponsored by Forest Laboratories.

COMPLETED
Registry status
Phase 3
Development phase
446 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

Trial Details

FieldValue
Enrollment Target 446 participants
Start Date 2010-04-27
Est. Completion 2011-12-15
Phase Phase 3
Forest Laboratories

145 total trials

What the finished NCT01104779 record still lists

NCT01104779 is an interventional study that assigns participants to a tested intervention. The registered 446 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 (42% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01104779 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01104779 about?

NCT01104779 is a clinical study titled "Safety and Efficacy of Cariprazine in 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 NCT01104779?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 446 participants. The study started on 2010-04-27. Estimated completion is 2011-12-15.

What interventions are being tested in trial NCT01104779?

The interventions under investigation include: Placebo (DRUG), Cariprazine (DRUG).

Who is sponsoring clinical trial NCT01104779?

This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01104779's enrollment target sits among peer trials

446 864th of 2000 higher than 1,137 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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Source: ClinicalTrials.gov NCT01104779, the US trial registry maintained by the National Library of Medicine. NCT01104779 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.