Study of Lumateperone in the Treatment of Patients With Bipolar Mania

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified May 2025 by Intra-Cellular Therapies, Inc.
Sponsor
Intra-Cellular Therapies, Inc.
Information Provided by (Responsible Party)
Intra-Cellular Therapies, Inc.
Clinicaltrials.gov Identifier
NCT06462612
Other Study ID Numbers:
ITI-007-452
First Submitted
June 11, 2024
First Posted
June 16, 2024
Last Update Posted
June 30, 2025
Last Verified
May 2025

ClinicalTrials.gov processed this data on June 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

The study will be conducted in 3 phases:

* Screening Period (up to 1 week) during which patient eligibility will be assessed.

* Double-blind Treatment Period (3 weeks) during which all eligible patients will be randomized to receive lumateperone 42 mg or placebo in 1:1 ratio.

* Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up visit

Condition or DiseaseIntervention/Treatment
Bipolar Disorder, Manic
Drug: LumateperoneDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment350 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleA Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients With Manic Episodes or Manic Episodes With Mixed Features Associated With Bipolar I Disorder (Bipolar Mania)
Study Start DateJuly 16, 2024
Actual Primary Completion DateApril 30, 2026
Actual Study Completion Date1w 3d from now

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures
  1. Young Mania Rating Scale (YMRS)
    The YMRS is an 11-item, clinician-administered mania rating scale designed to assess the severity of manic symptoms. Four of the YMRS items are rated on a 0 to 8 scale, with the remaining 7 items rated on a 0 to 4 scale. The total score ranges from 0 to 60 with a higher score indicating increased severity of manic symptoms.
Secondary Outcome Measures
  1. Clinical Global Impression Scale-Severity (CGI-S)
    The CGI-S is a clinician-rated scale to assess a patient's overall mental health. The scale ranges from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
1. Able to provide written informed consent before the initiation of any study specific procedures; 2. Male or female inpatient, between the ages of 18 and 75 years, inclusive; 3. Meets the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) criteria for bipolar I disorder with a current episode of mania or mania with mixed features with or without psychotic symptoms, as confirmed by a trained and Sponsor-approved rater using the modified Structured Clinical Interview for DSM-5, Clinical Trials Version (SCID-5-CT); 4. YMRS total score ≥ 20 and a score of at least 4 on two of the following YMRS items: irritability, speech, content, and disruptive/aggressive behavior at Screening and Baseline; 5. Hospitalized voluntarily before Screening or admitted to inpatient unit at Visit 1 with a primary diagnosis of mania but not \> 14 days before Screening. Hospital admission must be a result of the current manic episode.
Exclusion Criteria
1. Has a current primary DSM 5 psychiatric diagnosis other than bipolar disorder. These include: 1. Schizophrenia, schizoaffective disorder, or other psychotic disorders; 2. Dementia or other cognitive disorders; 3. Intellectual disability; 4. Moderate or severe substance use disorder (excluding for nicotine); 2. Experiencing first manic episode; 3. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during the course of his/her participation in the study or 1. At Screening, the patient scores "yes" on Items 4 or 5 in the Suicidal Ideation section of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening; or 2. At Screening, the patient has had 1 or more suicidal attempts within 2 years prior to Screening; or 3. At Baseline, the patient scores "yes" on Items 4 or 5 in the Suicidal Ideation section of the C-SSRS since the Screening Visit; or 4. At Screening or Baseline, scores ≥ 4 on Item 10 (suicidal thoughts) on the rater administered Montgomery-Åsberg Depression Rating Scale (MADRS); or 5. Considered to be an imminent danger to himself/herself or others.

Contacts and Locations

Sponsors and CollaboratorsIntra-Cellular Therapies, Inc.
Locations
Clinical Site | Bentonville Arkansas, United States, 72712Clinical Site | Little Rock Arkansas, United States, 72211Clinical Site | Anaheim California, United States, 92805Clinical Site | Cerritos California, United States, 90703Clinical Site | Orange California, United States, 92868Clinical Site | Torrance California, United States, 90504Clinical Site | Hialeah Florida, United States, 33012Clinical Site | Miami Florida, United States, 33122Clinical Site | Miami Florida, United States, 33135Clinical Site | Miami Florida, United States, 33145Clinical Site | Miami Lakes Florida, United States, 33014Clinical Site | Miami Lakes Florida, United States, 33016Clinical Site | Tampa Florida, United States, 33629Clinical Site | West Palm Beach Florida, United States, 33407Clinical Site | Atlanta Georgia, United States, 30331Clinical Site | Stockbridge Georgia, United States, 30281Clinical Site | Chicago Illinois, United States, 60640Clinical Site | Chicago Illinois, United States, 60641Clinical Site | Gaithersburg Maryland, United States, 20877Clinical Site | Glen Oaks New York, United States, 11004Clinical Site | Cincinnati Ohio, United States, 45219Clinical Site | Richardson Texas, United States, 75080Clinical Site | Burgas , Bulgaria, 8000Clinical Site | Kazanlak , Bulgaria, 6100Clinical Site | Plovdiv , Bulgaria, 4002Clinical Site | Sliven , Bulgaria, 8800Clinical Site | Sofia , Bulgaria, 1431Clinical Site | Brasov , Romania, 507190Clinical Site | Bucharest , Romania, 06022Clinical Site | Iași , Romania, 700282Clinical Site | Belgrade , Serbia, 11000Clinical Site | Kovin , Serbia, 26220Clinical Site | Kragujevac , Serbia, 34000Clinical Site | Niš , Serbia, Clinical Site | Novi Kneževac , Serbia,