Study of Lumateperone in the Acute 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
NCT06462586
Other Study ID Numbers:
ITI-007-451
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 DateJune 18, 2024
Actual Primary Completion DateFebruary 28, 2026
Actual Study Completion DateMarch 31, 2026

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 | Rogers Arkansas, United States, 72758Clinical Site | Bellflower California, United States, 90706Clinical 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 | Hallandale Florida, United States, 33009Clinical Site | Hialeah Florida, United States, 33016Clinical Site | Miami Florida, United States, 33184Clinical Site | Miami Gardens Florida, United States, 33056Clinical Site | Miami Lakes Florida, United States, 33016Clinical Site | Miami Springs Florida, United States, 33166Clinical Site | Orlando Florida, United States, 32807Clinical Site | Atlanta Georgia, United States, 30324Clinical Site | Atlanta Georgia, United States, 30338Clinical Site | Decatur Georgia, United States, 30030Clinical Site | Savannah Georgia, United States, 31405Clinical Site | Shreveport Louisiana, United States, 71101Clinical Site | Marlton New Jersey, United States, 08053Clinical Site | North Canton Ohio, United States, 44720Clinical Site | Austin Texas, United States, 78701Clinical Site | Austin Texas, United States, 78754Clinical Site | DeSoto Texas, United States, 75115Clinical Site | Lovech , Bulgaria, 5500Clinical Site | Rousse , Bulgaria, Clinical Site | Sofia , Bulgaria, 1377Clinical Site | Stara Zagora , Bulgaria, 6000Clinical Site | Veliko Tarnovo , Bulgaria, 5000Clinical Site | Vratsa , Bulgaria, 3000Clinical Site | Split , Croatia, 21000Clinical Site | Zagreb , Croatia, 10000Clinical Site | Zagreb , Croatia, 10090Clinical Site | Guwahati Assam, India, 781032Clinical Site | Mangalore Karnataka, India, 575018Clinical Site | Mysore Karnataka, India, 570001Clinical Site | Nashik Maharashtra, India, 422005Clinical Site | Ludhiana Punjab, India, 141001Clinical Site | Belgrade , Serbia, 11000Clinical Site | Kovin , Serbia, 26220Clinical Site | Kragujevac , Serbia, 34000Clinical Site | Novi Kneževac , Serbia, 23330Clinical Site | Novi Sad , Serbia, 21000