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NCT01499563 · ClinicalTrials.gov registry record · Phase 2
Study of a Novel Antipsychotic ITI-007 in Schizophrenia
A Phase 2 study, sponsored by Intra-Cellular Therapies.
- Completed
- Registry status
- Phase 2
- Development phase
- 335
- Enrollment target
NCT01499563: Completed Phase 2 study, sponsored by Intra-Cellular Therapies.
NCT01499563 is a Phase 2 study that has completed, run by Intra-Cellular Therapies. The registered enrollment target is 335 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (152% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01499563, a Phase 2 study, has completed, sponsored by Intra-Cellular Therapies.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 335 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate whether ITI-007 is effective in reducing symptoms associated with schizophrenia in patients who are having an acute worsening of their psychosis. Patients will be randomly assigned to receive one of two doses of ITI-007, placebo, or a positive control. The primary goal will be to assess the effects of ITI-007 on psychosis. The safety of ITI-007 will also be assessed.
Primary Outcome
The PANSS is a 30-item scale used to measure symptoms of schizophrenia. The scale has 7 positive symptom items, 7 negative symptom items, and 16 general psychopathology symptom items. Each item is scored on a 7-point scale by the clinical rater based on a clinical interview with the patient, with a score of 1 indicating the absence of symptoms and a score of 7 indicating extremely severe symptoms. Thus, the PANSS Total score minimum is 30 and the maximum is 210, with higher numbers indicating mo
Interventions
- DRUG Placebo
- DRUG Risperidone
- DRUG ITI-007
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 335 participants |
| Start Date | 2011-12 |
| Est. Completion | 2013-11 |
| Phase | Phase 2 |
What the finished NCT01499563 record still lists
NCT01499563 is an interventional study that assigns participants to a tested intervention. The registered 335 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (152% higher).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01499563 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01499563 about?
NCT01499563 is a clinical study titled "Study of a Novel Antipsychotic ITI-007 in Schizophrenia". The purpose of this study is to evaluate whether ITI-007 is effective in reducing symptoms associated with schizophrenia in patients who are having an acute worsening of their psychosis. Patients will be randomly assigned to receive one of two doses of ITI-007, placebo, or a positive control. The pr...
What is the current status of trial NCT01499563?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 335 participants. The study started on 2011-12. Estimated completion is 2013-11.
What interventions are being tested in trial NCT01499563?
The interventions under investigation include: Placebo (DRUG), Risperidone (DRUG), ITI-007 (DRUG).
Who is sponsoring clinical trial NCT01499563?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01499563's enrollment target sits among peer trials
335 142nd of 2000 higher than 1,858 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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