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

ITI-007-304

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).

2021-07-08

2024-08-01

2024-09-01

Active (not recruiting)

Early phase I

200

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).

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 200, 'type': 'ESTIMATED'}}

2024-02-14