Lumateperone for the Prevention of Relapse in Patients With Schizophrenia

Intra-Cellular Therapies

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Treatments

Drug: Lumateperone 42 mg

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04959032

ITI-007-304

Details and patient eligibility

About

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).

Full description

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.

Enrollment

228 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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).