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

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified June 2026 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 22, 2026
Last Verified
June 2026

ClinicalTrials.gov processed this data on July 2026. 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 13, 2024
Actual Primary Completion Date5yrs 3mos from now
Actual Study Completion Date5yrs 3mos 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
Harmonex Neuroscience Research | Dothan Alabama, United States, 36303Pillar Clinical Research, LLC | Little Rock Arkansas, United States, 72204Advanced Research Center, Inc | Anaheim California, United States, 92805Inland Psychiatric Medical Group Inc | Redlands California, United States, 92373UC Davis Health System | Sacramento California, United States, 95817University of California San Diego Medical Center | San Diego California, United States, 92103Next Level Clinical Trials, LLC | West Covina California, United States, 91790MCB Clinical Research Centers LLC | Colorado Springs Colorado, United States, 80910Royal Palm Clinical Research | Fort Myers Florida, United States, 33901United Research Institute | Hialeah Florida, United States, 33012Advanced Research Institute of Miami | Homestead Florida, United States, 33033Vital Care Research | Miami Florida, United States, 33122Columbus Clinical Services LLC | Miami Florida, United States, 33125Care Research Center Inc | Miami Florida, United States, 33130HealthMed Clinical Center Inc | Miami Florida, United States, 33134Ocean Blue Medical Research Center Inc. | Miami Florida, United States, 33144AP Medical Research | Miami Florida, United States, 33165Envision Trials LLC | Miami Florida, United States, 33166GTL Medical and Research Group | Miami Florida, United States, 33173Links Clinical Trials | Miami Florida, United States, 33176SouthGen Clinical Research LLC | Miami Florida, United States, 33186New Med Research Inc | Miami Gardens Florida, United States, 33056The Angel Medical Research Corporation | Miami Gardens Florida, United States, 33169Riveldi Biomedical Research | Miami Lakes Florida, United States, 33014APG Research LLC | Orlando Florida, United States, 32803Health Synergy Clinical Research | West Palm Beach Florida, United States, 33407CenExeli Research LLC | Atlanta Georgia, United States, 30030Advanced Discovery Research | Atlanta Georgia, United States, 30318Salveo Integrative Health Inc | Lawrenceville Georgia, United States, 30046CenExeli Research LLC 1 | Savannah Georgia, United States, 31405Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago Illinois, United States, 60611Revive Research Institute | Elgin Illinois, United States, 60123Indiana University | Indianapolis Indiana, United States, 46202MTP Psychiatry LLC | Baltimore Maryland, United States, 21229Neurobehavioral Medicine Group | Bloomfield Hills Michigan, United States, 48302Midwest Research Group | Saint Charles Missouri, United States, 63304Washington University School of Medicine Child and Adolescent Psychiatry Clinic | St Louis Missouri, United States, 63110Alivation Research LLC | Lincoln Nebraska, United States, 68526NYU Child Study Center | New York New York, United States, 10016Haidar Almhana Nieding | Avon Lake Ohio, United States, 44012University of Cincinnati Medical Center | Cincinnati Ohio, United States, 45219Charak Center for Health and Wellness | Garfield Heights Ohio, United States, 44125Westlake America Clinic | Westlake Ohio, United States, 44145SP Research, PLLC (dba Rivus Wellness & Research Institute) | Oklahoma City Oklahoma, United States, 73112Cutting Edge Research Group | Oklahoma City Oklahoma, United States, 73116Sooner Clinical Research | Oklahoma City Oklahoma, United States, 73116The University of Texas at Austin | Austin Texas, United States, 78701BioBehavioral Research of Austin PC | Austin Texas, United States, 78759REX Clinical Trials LLC | Beaumont Texas, United States, 77701North Pointe Psychiatry | Flower Mound Texas, United States, 76028Kaleidoscope Clinical Research | Houston Texas, United States, 77089Red Oak Psychiatry Associates | Houston Texas, United States, 77090Perceptive Pharma Research | Richmond Texas, United States, 77407Virginia Commonwealth University | Richmond Virginia, United States, 23220Northwest Clinical Research Center | Bellevue Washington, United States, 98007Core Clinical Research | Everett Washington, United States, 98201Centro de Investigaciones y Proyectos en Neurociencias CIPNA | Barranquilla , Colombia, 080020Empresa Social del Estado Hospital Mental de Antioquia Maria Upegui HOMO | Bello , Colombia, 051053Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda. | Bogotá , Colombia, 111166Psynapsis Salud Mental S.A. | Pereira , Colombia, 660002Ratandeep Surgical Hospital And Endoscopy Clinic | Ahmedabad , India, 380008Society for Psychiatric Update and Research Shanti Nursing Home | Aurangabad , India, 431005Chopda Medicare & Research Centre | Nashik , India, 422005Deva Institute of Healthcare And Research Pvt Ltd | Varanasi , India, 221005Clinic of Neurology and Psychiatry for Children and Youth | Belgrade , Serbia, 11000Institute of Mental Health Serbia | Belgrade , Serbia, 11000University Clinical Center NIS | Niš , Serbia, 18000Clinical Center of Vojvodina | Novi Sad , Serbia, 21000
Investigators
Study Director: Intra-Cellular Therapies, Inc. Clinical Trial, Intra-Cellular Therapies, Inc.