RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Lumateperone for Bipolar Depression

This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment 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).

Official registry: https://clinicaltrials.gov/study/NCT06372964 · Intra-Cellular Therapies, Inc. · enrollment listed as 384

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Lumateperone, or Placebo. The registry lists allocation as randomized. This is a multicenter, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment 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).

They plan to enroll about 384 people at 68 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Lumateperone, Placebo

Primary outcome (registry wording): Children's Depression Rating Scale-Revised (CDRS-R)

Who it is for (from inclusion criteria)

Ages 10 Years to 17 Years
The patient must provide written assent;
Male or female patients 10 to 17 years of age, inclusive;
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 the registry excludes

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;

Public study contact (from the registry)

Study Contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

68 listed

Harmonex Neuroscience Research — Dothan, Alabama (recruiting)
Pillar Clinical Research, LLC — Little Rock, Arkansas (recruiting)
Advanced Research Center, Inc — Anaheim, California (recruiting)
Inland Psychiatric Medical Group Inc — Redlands, California (recruiting)
UC Davis Health System — Sacramento, California (recruiting)
University of California San Diego Medical Center — San Diego, California (completed)
Next Level Clinical Trials, LLC — West Covina, California (recruiting)
MCB Clinical Research Centers LLC — Colorado Springs, Colorado (completed)
Royal Palm Clinical Research — Fort Myers, Florida (suspended)
United Research Institute — Hialeah, Florida (completed)
Advanced Research Institute of Miami — Homestead, Florida (suspended)
Vital Care Research — Miami, Florida (suspended)

+ 12 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06372964 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06372964?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06372964?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary