A Trial to Assess the Antipsychotic Efficacy of ITI-007

Intra-Cellular Therapies

Status and phase: Completed; Phase 3

Conditions: Schizophrenia

Treatments: Drug: ITI-007; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02282761

ITI-007-301

Details and patient eligibility

About

The study will be conducted as a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with schizophrenia having an acute exacerbation of psychosis.

Enrollment: 450 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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450 participants in 3 patient groups, including a placebo group

Lumateperone 28 mg (ITI-007 40 mg Tosylate)

Experimental group

Description:

Lumateperone 28 mg (ITI-007 40 mg Tosylate) administered orally as formulated capsules once daily for 28 days

Treatment:

Drug: ITI-007

Lumateperone 42 mg (ITI-007 60 mg Tosylate)

Experimental group

Description:

Lumateperone 42 mg (ITI-007 60 mg Tosylate) administered orally as formulated capsules once daily for 28 days

Treatment:

Drug: ITI-007

Placebo

Placebo Comparator group

Description:

Placebo administered orally as formulated capsules once daily for 28 days

Treatment:

Drug: Placebo