Lumateperone for the Prevention of Relapse in Patients With Schizophrenia

Completed · Phase 3 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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).

Key facts

Study ID

NCT04959032

Run by

Intra-Cellular Therapies, Inc.

People needed

228

Starts

2021-07-08

Expected to finish

2024-08-07

Last updated by the study team

2024-11-07

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Clinical Site — Little Rock, Arkansas, United States
• Clinical Site — Bellflower, California, United States
• Clinical Site — Cerritos, California, United States
• Clinical Site — Culver City, California, United States
• Clinical Site — Garden Grove, California, United States
• Clinical Site — Lemon Grove, California, United States
• Clinical Site — Montclair, California, United States
• Clinical Site — Orange, California, United States
• Clinical Site — Hollywood, Florida, United States
• Clinical Site — Miami Lakes, Florida, United States
• Clinical Site — Oakland Park, Florida, United States
• Clinical Site — Atlanta, Georgia, United States
• Clinical Site — Chicago, Illinois, United States
• Clinical Site — Boston, Massachusetts, United States
• Clinical Site — St Louis, Missouri, United States
• Clinical Site — Las Vegas, Nevada, United States
• Clinical Site — Berlin, New Jersey, United States
• Clinical Site — North Canton, Ohio, United States
• Clinical Site — Austin, Texas, United States
• Clinical Site — DeSoto, Texas, United States
• Clinical Site — Richardson, Texas, United States
• Clinical Site — Burgas, Bulgaria
• Clinical Site — Kardzhali, Bulgaria
• Clinical Site — Kazanlak, Bulgaria
• Clinical Site — Lovech, Bulgaria

Full record on ClinicalTrials.gov

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