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Study of a Novel Antipsychotic ITI-007 in Schizophrenia

This study is currently recruiting participants.
Verified January 2012 by Intra-Cellular Therapies, Inc.
Sponsor:
Information provided by (Responsible Party):
Intra-Cellular Therapies, Inc.
ClinicalTrials.gov Identifier:
NCT01499563
First received: December 16, 2011
Last updated: January 5, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Schizophrenia
 Drug: ITI-007
Drug: Placebo
Drug: Risperidone
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Multi-center Study to Assess the Antipsychotic Efficacy of ITI-007 in Patients With Schizophrenia

Resource links provided by NLM:

Drug Information available for: Risperidone
U.S. FDA Resources

Further study details as provided by Intra-Cellular Therapies, Inc.:

Primary Outcome Measures:
  • Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: Change from baseline to Day 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: Change from baseline to Day 8, 15, 22 ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: December 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ITI-007 Low Dose Drug: ITI-007
Capsules containing ITI-007 for 28 days
Drug: Placebo
Capsules containing inactive placebo for 28 days
Experimental: ITI-007 High Dose Drug: ITI-007
Capsules containing ITI-007 for 28 days
Placebo Comparator: Placebo Drug: Placebo
Capsules containing inactive placebo for 28 days
Active Comparator: Risperidone Drug: Risperidone
Capsules containing risperidone for 28 days

Detailed Description:

The study will be conducted as a randomized, double-blind, placebo-controlled, multi-center study in patients diagnosed with schizophrenia and an acute exacerbation of psychosis. The efficacy and safety of two dose levels of ITI-007 administered daily for 28 days will be evaluated as compared to placebo; risperidone has been included as a positive control.

Upon completion of the inpatient 28-day Study Treatment Period, patients will be started on standard antipsychotic medication and will be stabilized over a 5-day period before discharge from the study clinic. Patients will be seen for a final outpatient safety evaluation at the End-of-Study visit approximately 2 weeks after discharge.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient's age is 18-55
  • Patient has current diagnosis of schizophrenia and is experiencing an acute exacerbation of psychosis
  • Patient has a history of at least three months exposure to one or more antipsychotic therapy(ies) and a prior response to antipsychotic therapy within the previous five years

Exclusion Criteria:

  • Any female patient who is pregnant or breast-feeding
  • Any patient presenting with concurrent dementia, delirium, mental retardation, epilepsy, drug-induced psychosis, or history of significant brain trauma
  • Any patient presenting with schizoaffective disorder, bipolar disorder, acute mania, or major depression with psychotic features
  • Any patient considered to be an imminent danger to themselves or others
  • Any patient with hematological, renal, hepatic, endocrinological, neurological, or cardiovascular disease or substance abuse as defined by protocol
  • Any patient judged by the Investigator to be inappropriate for the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499563

Contacts
Contact: Min Handschuh (201) 636 2337 min.handschuh@parexel.com

Locations
United States, California
Recruiting
Long Beach, California, United States
Sponsors and Collaborators
Intra-Cellular Therapies, Inc.
Investigators
Study Director: Kimberly E Vanover, PhD Intra-Cellular Therapies
  More Information

No publications provided

Responsible Party: Intra-Cellular Therapies, Inc.
ClinicalTrials.gov Identifier: NCT01499563     History of Changes
Other Study ID Numbers: ITI-007-005
Study First Received: December 16, 2011
Last Updated: January 5, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
Risperidone
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on June 17, 2013