Bipolar DepressionPhase 3NCT06372964
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
A Phase 3 study testing Lumateperone in people with Bipolar Depression, run by Intra-Cellular Therapies, Inc. at 68 sites in 4 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Bipolar Depression
- What is being tested?
- Lumateperone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 384 participants
- Where
- 68 sitesin 4 countries
- Study dates
- 14 May 2024to 31 Oct 2031
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Able to provide consent as follows:
- The Legally Authorized Representative (LAR) must provide written, informed consent.
- The patient must provide written assent;
- Male or female patients 10 to 17 years of age, inclusive;
- 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);
- Subject has a lifetime history of at least one manic or hypomanic episode.
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- Subject's current major depressive episode is ≥ 4 weeks and less than 12 months in duration;
- CDRS-R total score ≥ 45 with ≥ 5 on Item 11 (depressed feelings) at Screening and Baseline;
- Young Mania Rating Scale (YMRS) score ≤ 15 (with YMRS Item 1 [elevated mood] score ≤ 2) at Screening and Baseline.
Who cannot join
- 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.
- Intellectual disability based on Investigator opinion and DSM-5 criteria
- Patient has been hospitalized for a bipolar manic episode within the 30 days prior to randomization;
- 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;
- In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or
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- 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;
- At Screening, the patient has had 1 or more suicidal attempts within the 2 years prior to Screening; or
- At Screening or Baseline, scores > 3 on Item 13 (suicidal ideation) on the CDRS-R; or
- The patient is considered to be an imminent danger to him/herself or others.
Trial locations and contacts
68 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
68 sites in 4 countries
United States56 sites, 34 recruiting
- Recruiting
Advanced Research Center, Inc
Anaheim, California, 92805
- Recruiting
CenExeli Research LLC
Atlanta, Georgia, 30030
- Completed
Advanced Discovery Research
Atlanta, Georgia, 30318
- Recruiting
The University of Texas at Austin
Austin, Texas, 78701
- Completed
BioBehavioral Research of Austin PC
Austin, Texas, 78759
- Completed
Haidar Almhana Nieding
Avon Lake, Ohio, 44012
- Completed
MTP Psychiatry LLC
Baltimore, Maryland, 21229
- Recruiting
REX Clinical Trials LLC
Beaumont, Texas, 77701
- Recruiting
Northwest Clinical Research Center
Bellevue, Washington, 98007
- Recruiting
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, 48302
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
- Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
- Completed
MCB Clinical Research Centers LLC
Colorado Springs, Colorado, 80910
- Recruiting
Harmonex Neuroscience Research
Dothan, Alabama, 36303
- Recruiting
Revive Research Institute
Elgin, Illinois, 60123
- Recruiting
Core Clinical Research
Everett, Washington, 98201
- Completed
North Pointe Psychiatry
Flower Mound, Texas, 76028
- Suspended
Royal Palm Clinical Research
Fort Myers, Florida, 33901
- Recruiting
Charak Center for Health and Wellness
Garfield Heights, Ohio, 44125
- Completed
United Research Institute
Hialeah, Florida, 33012
- Suspended
Advanced Research Institute of Miami
Homestead, Florida, 33033
- Recruiting
Kaleidoscope Clinical Research
Houston, Texas, 77089
- Completed
Red Oak Psychiatry Associates
Houston, Texas, 77090
- Completed
Indiana University
Indianapolis, Indiana, 46202
- Completed
Salveo Integrative Health Inc
Lawrenceville, Georgia, 30046
- Recruiting
Alivation Research LLC
Lincoln, Nebraska, 68526
- Recruiting
Pillar Clinical Research, LLC
Little Rock, Arkansas, 72204
- Suspended
Vital Care Research
Miami, Florida, 33122
- Completed
Columbus Clinical Services LLC
Miami, Florida, 33125
- Recruiting
Care Research Center Inc
Miami, Florida, 33130
- Recruiting
HealthMed Clinical Center Inc
Miami, Florida, 33134
- Completed
Ocean Blue Medical Research Center Inc.
Miami, Florida, 33144
- Suspended
AP Medical Research
Miami, Florida, 33165
- Recruiting
Envision Trials LLC
Miami, Florida, 33166
- Completed
GTL Medical and Research Group
Miami, Florida, 33173
- Recruiting
Links Clinical Trials
Miami, Florida, 33176
- Completed
SouthGen Clinical Research LLC
Miami, Florida, 33186
- Recruiting
New Med Research Inc
Miami Gardens, Florida, 33056
- Recruiting
The Angel Medical Research Corporation
Miami Gardens, Florida, 33169
- Recruiting
Riveldi Biomedical Research
Miami Lakes, Florida, 33014
- Recruiting
NYU Child Study Center
New York, New York, 10016
- Recruiting
SP Research, PLLC (dba Rivus Wellness & Research Institute)
Oklahoma City, Oklahoma, 73112
- Completed
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116
- Recruiting
Sooner Clinical Research
Oklahoma City, Oklahoma, 73116
- Recruiting
APG Research LLC
Orlando, Florida, 32803
- Recruiting
Inland Psychiatric Medical Group Inc
Redlands, California, 92373
- Recruiting
Perceptive Pharma Research
Richmond, Texas, 77407
- Recruiting
Virginia Commonwealth University
Richmond, Virginia, 23220
- Recruiting
UC Davis Health System
Sacramento, California, 95817
- Recruiting
Midwest Research Group
Saint Charles, Missouri, 63304
- Completed
University of California San Diego Medical Center
San Diego, California, 92103
- Recruiting
CenExeli Research LLC 1
Savannah, Georgia, 31405
- Completed
Washington University School of Medicine Child and Adolescent Psychiatry Clinic
St Louis, Missouri, 63110
- Recruiting
Next Level Clinical Trials, LLC
West Covina, California, 91790
- Recruiting
Health Synergy Clinical Research
West Palm Beach, Florida, 33407
- Completed
Westlake America Clinic
Westlake, Ohio, 44145
Colombia4 sites, 3 recruiting
- Recruiting
Centro de Investigaciones y Proyectos en Neurociencias CIPNA
Barranquilla, 080020
- Recruiting
Empresa Social del Estado Hospital Mental de Antioquia Maria Upegui HOMO
Bello, 051053
- Completed
Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.
Bogotá, 111166
- Recruiting
Psynapsis Salud Mental S.A.
Pereira, 660002
India4 sites
- Suspended
Ratandeep Surgical Hospital And Endoscopy Clinic
Ahmedabad, 380008
- Suspended
Society for Psychiatric Update and Research Shanti Nursing Home
Aurangabad, 431005
- Suspended
Chopda Medicare & Research Centre
Nashik, 422005
- Suspended
Deva Institute of Healthcare And Research Pvt Ltd
Varanasi, 221005
Serbia4 sites
- Active, not recruiting
Clinic of Neurology and Psychiatry for Children and Youth
Belgrade, 11000
- Active, not recruiting
Institute of Mental Health Serbia
Belgrade, 11000
- Active, not recruiting
University Clinical Center NIS
Niš, 18000
- Suspended
Clinical Center of Vojvodina
Novi Sad, 21000
About this study
Official title: A 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
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).
Read the 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.
- Conditions
- Bipolar Depression
- Being tested
- Lumateperone, Placebo
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LumateperoneDrug
Lumateperone administered orally, once daily.
PlaceboDrug
Matching placebo administered orally, once daily.
| Study group | Role | What they receive |
|---|---|---|
| Lumateperone | Experimental | Lumateperone 42 mg for patient ages 13-17 years and Lumateperone 21 mg for patient ages 10-12 years. Receives: Drug: Lumateperone |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 6
Secondary outcomes (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).
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start14 May 2024
- Primary completion31 Oct 2031 (estimated)
- Study completion31 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 384 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intra-Cellular Therapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Intra-Cellular Therapies, Inc. Clinical Trial, Study director, Intra-Cellular Therapies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06372964
- Sponsor's protocol ID
- ITI-007-421
- Other IDs
- ITI-007-421
- Status last verified
- Sep 2026
- First submitted
- 15 Apr 2024
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No