Lumateperone for the Prevention of Relapse in Patients With Schizophrenia
NCT ID: NCT04959032
Last Updated: 2024-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
228 participants
INTERVENTIONAL
2021-07-08
2024-08-07
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Lumateperone 42 mg
Lumateperone 42 mg
Lumateperone 42 mg capsules administered orally, once daily.
Placebo
Placebo
Matching capsules administered orally, once daily.
Interventions
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Lumateperone 42 mg
Lumateperone 42 mg capsules administered orally, once daily.
Placebo
Matching capsules administered orally, once daily.
Eligibility Criteria
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Inclusion Criteria
* 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
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).
18 Years
60 Years
ALL
No
Sponsors
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Intra-Cellular Therapies, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Clinical Site
Novi Iskar, , Bulgaria
Clinical Site
Pleven, , Bulgaria
Clinical Site
Plovdiv, , Bulgaria
Clinical Site
Rousse, , Bulgaria
Clinical Site
Sofia, , Bulgaria
Clinical Site
Targovishte, , Bulgaria
Clinical Site
Tsarev Brod, , Bulgaria
Clinical Site
Tserova Koria, , Bulgaria
Clinical Site
Veliko Tarnovo, , Bulgaria
Clinical Site
Vratsa, , Bulgaria
Clinical Site
Gdansk, , Poland
Clinical Site
Gdansk, , Poland
Clinical Site
Gorlice, , Poland
Clinical Site
Tuszyn, , Poland
Clinical site
Belgrade, , Serbia
Clinical Site
Kovin, , Serbia
Clinical Site
Kragujevac, , Serbia
Clinical Site
Novi Kneževac, , Serbia
Countries
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Other Identifiers
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ITI-007-304
Identifier Type: -
Identifier Source: org_study_id
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