Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Purpose
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients who are experiencing major depressive episodes (MDEs) associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL), according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5).
Condition
- Bipolar Depression
Eligibility
- Eligible Ages
- Between 10 Years and 17 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Lumateperone |
Lumateperone 42 mg for patient ages 13-17 years and Lumateperone 21 mg for patient ages 10-12 years. |
|
|
Placebo Comparator Placebo |
Matching placebo |
|
Recruiting Locations
Harmonex Neuroscience Research
Dothan, Alabama 36303
Dothan, Alabama 36303
Pillar Clinical Research, LLC
Little Rock, Arkansas 72204
Little Rock, Arkansas 72204
Advanced Research Center, Inc
Anaheim, California 92805
Anaheim, California 92805
Inland Psychiatric Medical Group Inc
Redlands, California 92373
Redlands, California 92373
UC Davis Health System
Sacramento, California 95817
Sacramento, California 95817
Next Level Clinical Trials, LLC
West Covina, California 91790
West Covina, California 91790
Care Research Center Inc
Miami, Florida 33130
Miami, Florida 33130
HealthMed Clinical Center Inc
Miami, Florida 33134
Miami, Florida 33134
Envision Trials LLC
Miami, Florida 33166
Miami, Florida 33166
Links Clinical Trials
Miami, Florida 33176
Miami, Florida 33176
New Med Research Inc
Miami Gardens, Florida 33056
Miami Gardens, Florida 33056
The Angel Medical Research Corporation
Miami Gardens, Florida 33169
Miami Gardens, Florida 33169
Riveldi Biomedical Research
Miami Lakes, Florida 33014
Miami Lakes, Florida 33014
APG Research LLC
Orlando, Florida 32803
Orlando, Florida 32803
Health Synergy Clinical Research
West Palm Beach, Florida 33407
West Palm Beach, Florida 33407
CenExeli Research LLC
Atlanta, Georgia 30030
Atlanta, Georgia 30030
CenExeli Research LLC 1
Savannah, Georgia 31405
Savannah, Georgia 31405
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
Chicago, Illinois 60611
Revive Research Institute
Elgin, Illinois 60123
Elgin, Illinois 60123
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan 48302
Bloomfield Hills, Michigan 48302
Midwest Research Group
Saint Charles, Missouri 63304
Saint Charles, Missouri 63304
Alivation Research LLC
Lincoln, Nebraska 68526
Lincoln, Nebraska 68526
NYU Child Study Center
New York, New York 10016
New York, New York 10016
University of Cincinnati Medical Center
Cincinnati, Ohio 45219
Cincinnati, Ohio 45219
Charak Center for Health and Wellness
Garfield Heights, Ohio 44125
Garfield Heights, Ohio 44125
SP Research, PLLC (dba Rivus Wellness & Research Institute)
Oklahoma City, Oklahoma 73112
Oklahoma City, Oklahoma 73112
Sooner Clinical Research
Oklahoma City, Oklahoma 73116
Oklahoma City, Oklahoma 73116
The University of Texas at Austin
Austin, Texas 78701
Austin, Texas 78701
BioBehavioral Research of Austin PC
Austin, Texas 78759
Austin, Texas 78759
REX Clinical Trials LLC
Beaumont, Texas 77701
Beaumont, Texas 77701
North Pointe Psychiatry
Flower Mound, Texas 76028
Flower Mound, Texas 76028
Kaleidoscope Clinical Research
Houston, Texas 77089
Houston, Texas 77089
Red Oak Psychiatry Associates
Houston, Texas 77090
Houston, Texas 77090
Perceptive Pharma Research
Richmond, Texas 77407
Richmond, Texas 77407
Virginia Commonwealth University
Richmond, Virginia 23220
Richmond, Virginia 23220
Northwest Clinical Research Center
Bellevue, Washington 98007
Bellevue, Washington 98007
Core Clinical Research
Everett, Washington 98201
Everett, Washington 98201
More Details
- Status
- Recruiting
- Sponsor
- Intra-Cellular Therapies, Inc.
Detailed 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.