Tests lumateperone for depression in teens with bipolar disorder
Compares lumateperone with placebo in children aged 10 to 17 with bipolar depression.
Plain-language title generated from the registry record
Registry title: Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Key facts
- Where
- Barranquilla, Bello, Bogotá, and Pereira, ColombiaSee the 4 sites
- Phase
- Phase 3
Could this be for you?
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?
Source: NCT06372964, who can take part
Where in Colombia
- Centro de Investigaciones y Proyectos en Neurociencias CIPNABarranquilla, ColombiaTaking people
- Empresa Social del Estado Hospital Mental de Antioquia Maria Upegui HOMOBello, ColombiaTaking people
- Centro de Investigaciones del Sistema Nervioso Grupo Cisne Ltda.Bogotá, ColombiaNo longer taking part
- Psynapsis Salud Mental S.A.Pereira, ColombiaTaking people
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?
Trial details
- Who runs it
- Intra-Cellular Therapies, Inc.
- Trial code
- NCT06372964
- Record updated
- 3 November 2026
- Original description
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 full original descriptionShow less
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).
Inclusion: 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.
Exclusion: 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.