Lumateperone for the Prevention of Relapse in Patients With Schizophrenia

Recruitment Status
COMPLETED
(See Contacts and Locations)Verified October 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 29, 2021
First Posted
July 11, 2021
Last Update Posted
November 6, 2024
Last Verified
October 2024

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

History of Changes

Study Details

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 DiseaseIntervention/Treatment
Schizophrenia
Drug: Lumateperone 42 mgDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment228 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
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 7, 2021
Actual Primary Completion DateJuly 24, 2024
Actual Study Completion DateAugust 6, 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
Matching capsules administered orally, once daily.

Outcome Measures

Primary Outcome Measures
  1. Time to first symptom relapse during the Double-blind Treatment Phase

Eligibility Criteria

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