A Trial to Assess the Antipsychotic Efficacy of ITI-007 Over 6 Weeks of Treatment

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: ITI-007; Drug: Placebo; Drug: Risperidone

• Registration Number: NCT02469155
• Lead Sponsor: Intra-Cellular Therapies, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-01
• Study First Submitted: 2015-06-09
• Study First Submitted QC: 2015-06-10
• Study First Posted: 2015-06-11
• Primary Completion: 2016-08
• Study Completion: 2016-08-01
• Disposition First Submitted: 2017-11-08
• Disposition First Submitted QC: 2017-11-08
• Disposition First Posted: 2017-11-14
• Results First Submitted: 2025-03-27
• Status Verified: 2025-09
• Results First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Results First Posted: 2025-10-02
• Last Update Posted: 2025-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 696

Inclusion Criteria

• male or female subjects of any race, ages 18-60 inclusive, with a clinical diagnosis of schizophrenia
• experiencing an acute exacerbation of psychosis

Exclusion Criteria

• any subject unable to provide informed consent
• any female subject who is pregnant or breast-feeding
• any subject judged to be medically inappropriate for study participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lumateperone 14 mg (ITI-007 20 mg Tosylate)	ITI-007	Lumateperone 14 mg (ITI-007 20 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks
Lumateperone 42 mg (ITI-007 60 mg Tosylate)	ITI-007	Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 6 weeks
Placebo	Placebo	Placebo administered orally as visually-matched capsules once daily for 6 weeks
Risperidone	Risperidone	Risperidone administered orally as visually-matched over-encapsulated tablet once daily for 6 weeks

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 6 in Positive and Negative Syndrome Scale (PANSS) Total Score	6 weeks	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 Week 6 in Clinical Global Impressions-Severity of Illness Scale	6 weeks	The Clinical Global Impressions (CGI) Scale is a standardized assessment tool that the clinician can use to rate the severity of illness, change over time, and efficacy of medication, taking into account the subject's clinical condition and the severity of side effects. The CGI Scale consists of 3 global subscales, only one of which was used in the present study. The first subscale, Severity of Illness (CGI-S), assesses the clinician's impression of the subject's current illness state; it is often used both before and after treatment. Scores on the Severity of Illness subscale range from 1 = "not ill" at all to 7 = "among the most extremely ill."

Trial Locations

Locations (1)

Clinical Site; 🇺🇸 Dallas, Texas, United States