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NCT02469155 · ClinicalTrials.gov registry record · Phase 3
A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment
A Phase 3 study, sponsored by Intra-Cellular Therapies.
- Completed
- Registry status
- Phase 3
- Development phase
- 696
- Enrollment target
NCT02469155: Completed Phase 3 study, sponsored by Intra-Cellular Therapies.
NCT02469155 is a Phase 3 study that has completed, run by Intra-Cellular Therapies. The registered enrollment target is 696 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02469155, a Phase 3 study, has completed, sponsored by Intra-Cellular Therapies.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 696 participants
- Enrollment target
Study Summary
The study will evaluate the antipsychotic efficacy of ITI-007 in a randomized, double-blind, parallel-group, placebo- and active-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis.
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 | 696 participants |
| Start Date | 2015-06 |
| Est. Completion | 2016-08 |
| Phase | Phase 3 |
What the finished NCT02469155 record still lists
NCT02469155 is an interventional study that assigns participants to a tested intervention. The registered 696 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 (10% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02469155 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02469155 about?
NCT02469155 is a clinical study titled "A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment". The study will evaluate the antipsychotic efficacy of ITI-007 in a randomized, double-blind, parallel-group, placebo- and active-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis.
What is the current status of trial NCT02469155?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 696 participants. The study started on 2015-06. Estimated completion is 2016-08.
What interventions are being tested in trial NCT02469155?
The interventions under investigation include: Placebo (DRUG), Risperidone (DRUG), ITI-007 (DRUG).
Who is sponsoring clinical trial NCT02469155?
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 NCT02469155's enrollment target sits among peer trials
696 518th of 2000 higher than 1,483 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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