Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified June 2025 by Intra-Cellular Therapies, Inc.
Sponsor
Intra-Cellular Therapies, Inc.
Information Provided by (Responsible Party)
Intra-Cellular Therapies, Inc.
Clinicaltrials.gov Identifier
NCT06372964
Other Study ID Numbers:
ITI-007-421
First Submitted
April 14, 2024
First Posted
April 17, 2024
Last Update Posted
July 7, 2025
Last Verified
June 2025

ClinicalTrials.gov processed this data on July 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 2 weeks) during which patient eligibility will be assessed

* Double-blind Treatment Period (6 weeks) during which all patients will be randomized to receive lumateperone 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 (SFU) visit approximately one week after the last dose of study drug.

Condition or DiseaseIntervention/Treatment
Bipolar Depression
Drug: LumateperoneDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment384 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lumateperone for the Treatment of Major Depressive Episodes (MDEs) Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) in Pediatric Patients Aged 10 to 17 Years
Study Start DateMay 12, 2024
Actual Primary Completion Date9mos 2w from now
Actual Study Completion Date10mos 2w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Lumateperone
Lumateperone 42 mg for patient ages 13-17 years and Lumateperone 21 mg for patient ages 10-12 years.
Drug: Lumateperone
Lumateperone administered orally, once daily.
Placebo
Matching placebo
Drug: Placebo
Matching placebo administered orally, once daily.

Outcome Measures

Primary Outcome Measures
  1. Children's Depression Rating Scale-Revised (CDRS-R)
    The Children's Depression Rating Scale-Revised is an observer-rated, 17-item semi-structured scale for pediatric patients. The scale comprises cognitive, somatic, affective, and psychomotor symptoms of depression. Items are rated for severity on a 7-point scale (1 to 7) for 14 items and on a 5-point scale (1 to 5) for three items. Total scores range from 7 to 113.
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(Child)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
1. Able to provide consent as follows:
The Legally Authorized Representative (LAR) must provide written, informed consent.
The patient must provide written assent; 2. Male or female patients 10 to 17 years of age, inclusive; 3. Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition Text Revision (DSM-5-TR) primary diagnosis of bipolar I or bipolar II disorder with a current MDE without psychosis as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL); 4. Subject has a lifetime history of at least one manic or hypomanic episode. 5. Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration; 6. CDRS-R total score ≥ 45 with ≥ 5 on Item 11 (depressed feelings) at Screening and Baseline; 7. Young Mania Rating Scale (YMRS) score ≤ 15 (with YMRS Item 1 \[elevated mood\] score ≤ 2) at Screening and Baseline.
Exclusion Criteria
1. Has a primary psychiatric diagnosis other than bipolar I or bipolar II disorder. Exception includes:
Attention deficit hyperactivity disorder (ADHD). If a subject is taking medications for ADHD, they must have been on a stable treatment regimen of these medication(s) for 30 days prior to screening and the treatment regimen is expected to remain stable throughout the study. 2. Intellectual disability based on Investigator opinion and DSM-5 criteria 3. Patient has been hospitalized for a bipolar manic episode within the 30 days prior to randomization; 4. Demonstrates a ≥ 25% decrease (improvement) in the CDRS-R total score between Screening and Baseline visits, or the CDRS-R is below 45 at Baseline; 5. In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or 1. At Screening, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS) within 6 months prior to Screening or, at Baseline, the patient scores "yes" on Suicidal Ideation Items 3, 4, or 5 since the Screening Visit; 2. At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or 3. At Screening or Baseline, scores \> 3 on Item 13 (suicidal ideation) on the CDRS-R; or 4. The patient is considered to be an imminent danger to him/herself or others.

Contacts and Locations

Sponsors and CollaboratorsIntra-Cellular Therapies, Inc.
Locations
Clinical Site | Dothan Alabama, United States, 36303Clinical Site | Little Rock Arkansas, United States, 72204Clinical Site | Anaheim California, United States, 92805Clinical Site | Redlands California, United States, 92373Clinical Site | Sacramento California, United States, 95817Clinical Site | San Diego California, United States, 92103Clinical Site | West Covina California, United States, 91790Clinical Site | Colorado Springs Colorado, United States, 80910Clinical Site | Gainesville Florida, United States, 32607Clinical Site | Hialeah Florida, United States, 33012Clinical Site | Homestead Florida, United States, 33030Clinical Site | Miami Florida, United States, 33122Clinical Site | Miami Florida, United States, 33125Clinical Site | Miami Florida, United States, 33130Clinical Site | Miami Florida, United States, 33134Clinical Site | Miami Florida, United States, 33144Clinical Site | Miami Florida, United States, 33165Clinical Site | Miami Florida, United States, 33173Clinical Site | Miami Florida, United States, 33176Clinical Site | Miami Florida, United States, 33186Clinical Site | Miami Gardens Florida, United States, 33056Clinical Site | Miami Lakes Florida, United States, 33014Clinical Site | Miami Lakes Florida, United States, 33016Clinical Site | Miami Springs Florida, United States, 33166Clinical Site | Orlando Florida, United States, 32803Clinical Site | West Palm Beach Florida, United States, 33407Clinical Site | Atlanta Georgia, United States, 30318Clinical Site | Decatur Georgia, United States, 30030Clinical Site | Lawrenceville Georgia, United States, 30046Clinical Site | Savannah Georgia, United States, 31405Clinical Site | Chicago Illinois, United States, 60611Clinical Site | Indianapolis Indiana, United States, 46202Clinical Site | Baltimore Maryland, United States, 21229Clinical Site | Bloomfield Hills Michigan, United States, 48302Clinical Site | Saint Charles Missouri, United States, 63304Clinical Site | Lincoln Nebraska, United States, 68526Clinical Site | Kinston North Carolina, United States, 28504Clinical Site | Avon Lake Ohio, United States, 44012Clinical Site | Cincinnati Ohio, United States, 45219Clinical Site | Garfield Ohio, United States, 44125Clinical Site | Westlake Ohio, United States, 44145Clinical Site | Oklahoma City Oklahoma, United States, 73112Clinical Site | Oklahoma City Oklahoma, United States, 73116Clinical Site | Austin Texas, United States, 78759Clinical Site | Flower Mound Texas, United States, 76028Clinical Site | Frisco Texas, United States, 75034Clinical Site | Houston Texas, United States, 77089Clinical Site | Houston Texas, United States, 77090Clinical Site | Richmond Texas, United States, 77407Clinical Site | Richmond Virginia, United States, 23220Clinical Site | Bellevue Washington, United States, 98007Clinical Site | Everett Washington, United States, 98201Clinical Site | Ahmedabad , India, 380008Clinical Site | Aurangabad , India, 431005Clinical Site | Nashik , India, 422005Clinical Site | Varanasi , India, 221005Clinical Site | Belgrade , Serbia, 11000Clinical Site | Niš , Serbia, 18000Clinical Site | Novi Sad , Serbia, 21000