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 February 12, 2024. Link to the current ClinicalTrials.gov record.

Recruitment Status

ACTIVE, NOT RECRUITING (See Contacts and Locations)
Verified February 2024 by Intra-Cellular Therapies, Inc.


Intra-Cellular Therapies, Inc.

Information Provided by (Responsible Party)

Intra-Cellular Therapies, Inc.

Clinicaltrials.gov Identifier

Other Study ID Numbers: ITI-007-304
First Submitted: June 30, 2021
First Posted: July 12, 2021
Last Update Posted: February 14, 2024
Last Verified: February 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 TypeInterventional
Anticipated Enrollment200 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
Primary PurposeTreatment
Official TitleA Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Lumateperone for the Prevention of Relapse in Patients With Schizophrenia
Study Start DateJuly 8, 2021
Anticipated Primary Completion DateAugust 2024
Anticipated Study Completion DateSeptember 2024

Groups and Cohorts

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

    Outcome Measures

    Primary Outcome Measures

    1. 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.
    • 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