Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients

L
Leslie Hulvershorn, MD, MSc

Primary Investigator

Recruiting
10 years - 17 years
All
Phase N/A
2 participants needed
1 Location

Brief description of study

The purpose of this study is to investigate the use of an investigational medication for treating major depressive episodes in children and teenagers with bipolar disorder. This study will involve pediatric patients aged 10 to 17 years who have been diagnosed with either bipolar I or bipolar II disorder.
 
Bipolar disorder is a mental health condition that causes extreme mood swings, including emotional highs (mania or hypomania) and lows (depression). 

Detailed description of study

What will happen during the study?

Participants will undergo a screening period to determine eligibility, followed by a double-blind treatment period where they will receive either the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study will conclude with a safety follow-up to monitor participants' health after treatment.

  • Who can participate: Children and teenagers aged 10 to 17 years with a primary diagnosis of bipolar I or bipolar II disorder and experiencing a major depressive episode may participate. They must have had at least one manic or hypomanic episode in their lifetime.
  • Study details: Participants will be randomly assigned to receive either the investigational medication or a placebo during the treatment period. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. They will be monitored for any changes in their condition through regular assessments and a follow-up visit to ensure safety.
  • Study timelines: The study will last 9 weeks.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Bipolar I Disorder, Bipolar II Disorder, Riley
  • Age: 10 years - 17 years
  • Gender: All

Inclusion Criteria:

  1. Able to provide consent as follows:
    • The child's legally Authorized Representative must provide a written informed consent.
    • The child must provide written assent.
  2. Male or female patients 10 to 17 years of age
  3. The child has primary diagnosis of bipolar I or bipolar II disorder with a current major depressive episode without psychosis.
  4. The child has a lifetime history of at least one manic or hypomanic episode.
  5. The child's current major depressive episode is ≥ 4 weeks and less than 12 months in duration.

Exclusion Criteria:

  1. The child has a primary psychiatric diagnosis other than bipolar I or bipolar II disorder. Except ADHD
  2. The child has any degree of Intellectual disability
  3. The child has been hospitalized for a bipolar manic episode within the 30 days prior to randomization
  4. The child has a significant risk for suicidal behavior during his/her participation in the study or has had 1 or more suicidal attempts in the past the 2 years
  5. The child is considered to be an imminent danger to him/herself or others

Other inclusion and exclusion criteria may apply

Updated on 12 Aug 2025. Study ID: PSYC-ICT-ITI-007-421, 23566

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