A Phase 3 interventional study of Lumateperone and Placebo in Bipolar Depression, sponsored by Intra-Cellular Therapies, Inc.. Recruiting at 68 sites in 4 countries. Open to participants aged 10 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Intra-Cellular Therapies, Inc. (part of Johnson & Johnson) · Phase 3, Interventional, and Treatment
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 study will be conducted in 3 phases:
1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.
This study's planned enrollment of 384 is above the median of 64 across 1,279 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Intra-Cellular Therapies, Inc. is the lead sponsor of 41 studies on the registry; 12 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 11 (46%) have results posted.
First submitted before Intra-Cellular Therapies, Inc. became part of Johnson & Johnson.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Able to provide consent as follows:
Exclusion Criteria:
Has a primary psychiatric diagnosis other than bipolar I or bipolar II disorder. Exception includes:
In the opinion of the Investigator, the patient has a significant risk for suicidal behavior during his/her participation in the study or
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Lumateperone 42 mg for patient ages 13-17 years and Lumateperone 21 mg for patient ages 10-12 years.
Drug: Lumateperone
Matching placebo
Drug: Placebo
Lumateperone administered orally, once daily.
Matching placebo administered orally, once daily.
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.
Time frame: Week 6
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).
Time frame: Week 6
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Lumateperone
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