Study of a Novel Antipsychotic ITI-007 in Schizophrenia

Phase 2

Completed

Conditions: Schizophrenia

Interventions: Drug: ITI-007
Drug: Risperidone
Drug: Placebo

Registration Number: NCT01499563

Lead Sponsor: Intra-Cellular Therapies, Inc.

Brief 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 335

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ITI-007 Low Dose	ITI-007	Lumateperone 42 mg (ITI-007 60 mg tosylate) administered for 28 days
ITI-007 Low Dose	Placebo	Lumateperone 42 mg (ITI-007 60 mg tosylate) administered for 28 days
ITI-007 High Dose	ITI-007	Lumateperone 84 mg (ITI-007 120 mg tosylate) administered for 28 days
Placebo	Placebo	Placebo: Capsules containing inactive placebo administered for 28 days
Risperidone	Risperidone	Risperidone: Capsules containing 4 mg risperidone administered for 28 days

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Day 28 in Positive and Negative Syndrome Scale (PANSS) Total Score	Change from baseline to Day 28	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 more severe symptoms.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline to Day 8 in Positive and Negative Syndrome Scale (PANSS) Total Score	Change from Baseline to Day 8	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 more severe symptoms.
Change From Baseline to Day 15 in Positive and Negative Syndrome Scale (PANSS) Total Score	Change from Baseline to Day 15	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 more severe symptoms.
Change From Baseline to Day 22 in Positive and Negative Syndrome Scale (PANSS) Total Score	Change from Baseline to Day 22	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 more severe symptoms.