Study of a Novel Antipsychotic ITI-007 in Schizophrenia

Intra-Cellular Therapies

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Placebo; Drug: Risperidone; Drug: ITI-007

Study type: Interventional

Funder types: Industry

Identifiers

NCT01499563

ITI-007-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 335 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

335 participants in 4 patient groups, including a placebo group

ITI-007 Low Dose

Experimental group

Description:

Lumateperone 42 mg (ITI-007 60 mg tosylate) administered for 28 days

Treatment:

Drug: ITI-007

Drug: Placebo

ITI-007 High Dose

Experimental group

Description:

Lumateperone 84 mg (ITI-007 120 mg tosylate) administered for 28 days

Treatment:

Drug: ITI-007

Placebo

Placebo Comparator group

Description:

Placebo: Capsules containing inactive placebo administered for 28 days

Treatment:

Drug: Placebo

Risperidone

Active Comparator group

Description:

Risperidone: Capsules containing 4 mg risperidone administered for 28 days

Treatment:

Drug: Risperidone