Lumateperone for the Prevention of Relapse in Patients With Schizophrenia Clinical Trial Results and Information

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

ClinicalTrials.gov processed this data on November 6, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

COMPLETED (See Contacts and Locations)
Verified November 2024 by Intra-Cellular Therapies, Inc.

Sponsor

Intra-Cellular Therapies, Inc.

Information Provided by (Responsible Party)

Intra-Cellular Therapies, Inc.

Clinicaltrials.gov Identifier

NCT04959032
Other Study ID Numbers: ITI-007-304
First Submitted: June 30, 2021
First Posted: July 12, 2021
Last Update Posted: November 7, 2024
Last Verified: November 2024
History of Changes

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Study 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.

Condition or Disease	Intervention/Treatment
Schizophrenia	Drug: Lumateperone 42 mg Drug: Placebo

Study Design

Study Type	Interventional
Actual Enrollment	228 participants
Design Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Quadruple
Primary Purpose	Treatment
Official Title	A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Lumateperone for the Prevention of Relapse in Patients With Schizophrenia
Study Start Date	July 8, 2021
Actual Primary Completion Date	July 25, 2024
Actual Study Completion Date	August 7, 2024

Groups and Cohorts

Group/ Cohort	Intervention/ Treatment
Lumateperone 42 mg	Drug: Lumateperone 42 mg Lumateperone 42 mg capsules administered orally, once daily.
Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures

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.]

Eligibility Criteria

Ages Eligible for Study	18 Years to 60 Years (Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	No
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).

Contacts and Locations

Sponsors and Collaborators	Intra-Cellular Therapies, Inc.
Locations	Clinical Site \| Little Rock, Arkansas, United States, 72211 Clinical Site \| Bellflower, California, United States, 907006 Clinical Site \| Cerritos, California, United States, 90703 Clinical Site \| Culver City, California, United States, 90230 Clinical Site \| Garden Grove, California, United States, 92845 Clinical Site \| Lemon Grove, California, United States, 91945 Clinical Site \| Montclair, California, United States, 91763 Clinical Site \| Orange, California, United States, 92869 Clinical Site \| Hollywood, Florida, United States, 33021 Clinical Site \| Miami Lakes, Florida, United States, 33016 Clinical Site \| Oakland Park, Florida, United States, 33334 Clinical Site \| Atlanta, Georgia, United States, 30331 Clinical Site \| Chicago, Illinois, United States, 60640 Clinical Site \| Boston, Massachusetts, United States, 02114 Clinical Site \| Saint Louis, Missouri, United States, 63141 Clinical Site \| Las Vegas, Nevada, United States, 89102 Clinical Site \| Berlin, New Jersey, United States, 08009 Clinical Site \| North Canton, Ohio, United States, 44720 Clinical Site \| Austin, Texas, United States, 78754 Clinical Site \| DeSoto, Texas, United States, 75115 Clinical Site \| Richardson, Texas, United States, 75080 Clinical Site \| Burgas, Bulgaria, 8000 Clinical Site \| Kardzhali, Bulgaria, 6600 Clinical Site \| Kazanlak, Bulgaria, 6100 Clinical Site \| Lovech, Bulgaria, 5500 Clinical Site \| Novi Iskar, Bulgaria, 1282 Clinical Site \| Pleven, Bulgaria, 5800 Clinical Site \| Plovdiv, Bulgaria, 4002 Clinical Site \| Russe, Bulgaria, 7003 Clinical Site \| Sofia, Bulgaria, 1377 Clinical Site \| Targovishte, Bulgaria, 7700 Clinical Site \| Tsarev Brod, Bulgaria, 9747 Clinical Site \| Tserova Koria, Bulgaria, 5047 Clinical Site \| Veliko Tarnovo, Bulgaria, 5000 Clinical Site \| Vratsa, Bulgaria, 3000 Clinical Site \| Gdańsk, Poland, 80-214 Clinical Site \| Gdańsk, Poland, 80-282 Clinical Site \| Gorlice, Poland, 3-8300 Clinical Site \| Tuszyn, Poland, 95080 Clinical site \| Belgrade, Serbia, 11000 Clinical Site \| Kovin, Serbia, 26220 Clinical Site \| Kragujevac, Serbia, 34000 Clinical Site \| Novi Kneževac, Serbia, 23330

More Information

Additional Relevant MeSH Terms

Recurrence
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Disease Attributes
Pathologic Processes