Taking peoplePhase 3
Tests lumateperone for depression in teens with bipolar disorder
Compares lumateperone with placebo in children aged 10 to 17 with bipolar depression.
Key facts
- Who runs it
- Intra-Cellular Therapies, Inc.
- Where
- Ahmedabad, Chhatrapati Sambhajinagar, Nashik, and Varanasi, IndiaSee the 4 sitesAlso in 3 other countries, 64 sites
- Trial code
- Registry title
- Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 384 people, planned
- Started
- 14 May 2024
- Expected to end
- 31 Oct 2031
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Lumateperone
- Placebo
- Record updated
- 3 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for children and teens aged 10 to 17 with bipolar I or bipolar II disorder who are in a major depressive episode.
- Age
- 10 to 17 years
- Sex
- Boys and girls can both join.
- Disease stage
- Bipolar I or bipolar II disorder with a current major depressive episode without psychosis. The episode has lasted at least 4 weeks and less than 12 months. At least one past manic or hypomanic episode.
- Earlier treatment
- If taking ADHD medicine, the dose must have been stable for 30 days before screening and expected to stay stable.
- Biomarker or test result
- Depression score CDRS-R total of at least 45, with at least 5 on Item 11. Mania score YMRS of 15 or less, with Item 1 of 2 or less.
Main reasons for not taking part
- A main psychiatric diagnosis other than bipolar I or bipolar II (ADHD is allowed)
- Intellectual disability
- Hospital stay for a manic episode in the 30 days before randomization
- Significant risk of suicidal behavior, recent suicidal thoughts or a suicide attempt in the last 2 years
- CDRS-R score improved by 25% or more between screening and baseline, or below 45 at baseline
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
- 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 take part
- 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
- Patient has been hospitalized for a bipolar manic episode within the 30 days prior to randomization
- In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or; 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
- Intellectual disability based on Investigator opinion and DSM-5 criteria
- 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
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 10 and 17 years old?
Where in India
Also in 3 other countries, 64 sites
- Ratandeep Surgical Hospital And Endoscopy ClinicAhmedabad, IndiaNo longer taking part
- Society for Psychiatric Update and Research Shanti Nursing HomeChhatrapati Sambhajinagar, IndiaNo longer taking part
- Chopda Medicare & Research CentreNashik, IndiaNo longer taking part
- Deva Institute of Healthcare And Research Pvt LtdVaranasi, IndiaNo longer taking part
About the trial
What the trial wants to find out
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).
The 2 groups in the trial
- LumateperoneTreatment being tested
Lumateperone 42 mg for patient ages 13-17 years and Lumateperone 21 mg for patient ages 10-12 years.
- PlaceboPlacebo, for comparison
Matching placebo
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Plain-language title
- Tests lumateperone for depression in teens with bipolar disorderGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06372964, who can take part
- Record updated
- 3 November 2026