Lumateperone for the Prevention of Relapse in Patients With Schizophrenia

Study Overview
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Brief Summary
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This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in adult patients with a primary diagnosis of schizophrenia according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5).

Detailed Description
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The study will be conducted in the following 5 phases: A no-drug Screening Phase up to 7 days in duration during which patient eligibility will be assessed; A 6-week, open-label Run-in Phase (RIP) during which all patients will receive oral lumateperone 42 mg/day; A 12-week, open-label Stabilization Phase (SP) during which all patients will receive oral lumateperone 42 mg/day; A Double-blind Treatment Phase (DBTP) 26 weeks in duration during which patients receive either lumateperone 42 mg or placebo (1:1 ratio); A 2-week Safety Follow-up (SFU) Phase.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Lumateperone for the Prevention of Relapse in Patients With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Lumateperone 42 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 18 to 60 years of age, inclusive. Current diagnosis of schizophrenia according to DSM-5 criteria as determined by the modified Structured Clinical Interview for DSM-5 (modified SCID-5). Diagnosis of schizophrenia for a minimum of 1 year before Visit 1. Current psychotic episode < 4 weeks duration at Visit 1. PANSS total score ≥ 70 and ≤ 120 at Visit 1 and Visit 2. Rating of at least 4 (moderate) on at least two of the following four PANSS positive symptoms: delusions (P1), hallucinatory behavior (P3), conceptual disorganization (P2), suspiciousness/persecution (P6) at Visit 1 and Visit 2. Patient must identify a caregiver who provides consents to participate in the study. In the opinion of the Investigator, the patient has significant risk for suicidal behavior during the course of his/her participation in the study. Exclusion Criteria: Currently meeting DSM-5 criteria for any of the following: Schizoaffective disorder, schizophreniform disorder, and other psychotic disorders; Bipolar I or Bipolar II Disorder; Intellectual developmental disorder, delirium, dementia, amnestic and other cognitive disorders; Known or suspected borderline or antisocial personality disorder or other DSM 5 personality disorder of sufficient severity to interfere with participation in this study; Substance use disorder (other than nicotine) within the 3 months prior to Visit 1 of this study. Patients in their first episode of psychosis. Treatment-resistant schizophrenia over the last 2 years, defined as little or no symptomatic response to at least 2 courses of antipsychotic treatment of an adequate duration (at least 6 weeks) and at a therapeutic dose (according to the package insert for the antipsychotic treatment).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumateperone 42 mg<br> | Drug: Lumateperone 42 mg<br>* Lumateperone 42 mg capsules administered orally, once daily.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Matching capsules administered orally, once daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first symptom relapse during the Double-blind Treatment Phase |  | Number of days from the randomization date to the first relapse date up to 26 weeks. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Relapse Prevention, Maintenance Design