Bipolar Depression study: Lumateperone
Official title Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
ClinicalTrials.gov ID: NCT06372964
What this study is testing
What is Lumateperone?
This is an investigational oral medicine being studied as a potential treatment for bipolar depression in children and teens. It is designed to affect certain chemicals in the brain, such as dopamine and serotonin, to help manage mood symptoms.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if lumateperone is effective and safe for treating major depressive episodes in young people with bipolar I or bipolar II disorder.
- Who it's for
- The study is looking for children and teenagers who have a confirmed diagnosis of bipolar I or bipolar II disorder and are currently experiencing a major depressive episode.
- What's involved
- Participants will be randomly assigned to receive either the study drug lumateperone or a placebo (a pill with no active medicine). Both groups will undergo regular medical evaluations to monitor their condition and safety.
- Time commitment
- The source text does not specify the total duration of the study or the exact number of visits required.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 17
You may be able to join if
- 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...
- Subject has a lifetime history of at least one manic or hypomanic episode.
You likely can't join if
- Attention deficit hyperactivity disorder (ADHD). If a subject is taking medications for ADHD, they must have been on a stable treatment regimen of...
- 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...
See the full eligibility criteria
- 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...
- 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.
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Dothan, Alabama, United States
- Little Rock, Arkansas, United States
- Anaheim, California, United States
- Redlands, California, United States
- Sacramento, California, United States
- West Covina, California, United States
- Miami, Florida, United States
- Miami Gardens, Florida, United States
- Miami Lakes, Florida, United States
- Orlando, Florida, United States
- West Palm Beach, Florida, United States
- Atlanta, Georgia, United States
- Savannah, Georgia, United States
- Chicago, Illinois, United States
- Elgin, Illinois, United States
- Bloomfield Hills, Michigan, United States
- Saint Charles, Missouri, United States
- Lincoln, Nebraska, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Dothan, Alabama, United States; Little Rock, Arkansas, United States; Anaheim, California, United States; Redlands, California, United States; Sacramento, California, United States; West Covina, California, United States and 26 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.