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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 is a Phase 2 study that has completed, run by Intra-Cellular Therapies. The registered enrollment target is 335 participants.

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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.

Interventions

  • DRUG Placebo
  • DRUG Risperidone
  • DRUG ITI-007

Trial Details

FieldValue
Enrollment Target 335 participants
Start Date 2011-12
Est. Completion 2013-11
Phase Phase 2

Sponsor

Intra-Cellular Therapies

37 total trials

What the Registry Record Tells You About NCT01499563

The ClinicalTrials.gov registry entry for NCT01499563 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 335 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intra-Cellular Therapies, which has 37 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT01499563 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.