Study of a Novel Antipsychotic ITI-007 in Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Intra-Cellular Therapies, Inc.
ClinicalTrials.gov Identifier:
NCT01499563
First received: December 16, 2011
Last updated: September 3, 2014
Last verified: September 2014
  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:


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 ]

Enrollment: 335
Study Start Date: December 2011
Study Completion Date: November 2013
Primary Completion Date: August 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499563

Locations
United States, California
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: September 3, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 20, 2014