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.
Sponsor
Intra-Cellular Therapies, Inc.Information Provided by (Responsible Party)
Intra-Cellular Therapies, Inc.Clinicaltrials.gov Identifier
NCT04959032Other 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 |
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Study Design
Study Type | Interventional |
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Anticipated Enrollment | 200 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 |
Anticipated Primary Completion Date | August 2024 |
Anticipated Study Completion Date | September 2024 |
Groups and Cohorts
Group/ Cohort | Intervention/ Treatment |
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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) |
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Sexes Eligible for Study | All |
Accepts Healthy Volunteers | No |
Inclusion Criteria |
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Exclusion Criteria |
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Contacts and Locations
Sponsors and Collaborators | Intra-Cellular Therapies, Inc. |
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Locations |
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More Information
Additional Relevant MeSH Terms
- Recurrence
- Schizophrenia
- Schizophrenia Spectrum and Other Psychotic Disorders
- Mental Disorders
- Disease Attributes
- Pathologic Processes