Last updated 9 days ago
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
384 patients around the world
Available in United States, Colombia
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.
Intra-Cellular Therapies, Inc.
3Research sites
384Patients around the world
This study is for people with
Depression
Bipolar major depression
Bipolar disorder
Requirements for the patient
To 17 Years
All Gender
Medical requirements
- 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.
- 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.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.
Sites
CIPNA LTDA IPS Centro de Investigación y Proyectos en Neurociencias
Recruiting
ESE Hospital Mental de Antioquia
Recruiting
Psynapsis Salud Mental S.A.
Recruiting
SponsorIntra-Cellular Therapies, Inc.
Study typeInterventional
Conditions
Bipolar major depressionBipolar disorder
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06372964
