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Lumateperone for Pediatric Bipolar Depression

Phase 3
Recruiting
Research Sponsored by Intra-Cellular Therapies, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female patients 13 to 17 years of age, inclusive.
Have a DSM-5-TR primary diagnosis of bipolar I or bipolar II disorder with a current MDE without psychosis as confirmed by K-SADS-PL.
Must not have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6
Awards & highlights
Pivotal Trial

Summary

"This trial is studying the effectiveness of a new treatment for children with bipolar disorder who are also experiencing major depressive episodes. The study is being conducted at multiple locations and will involve random assignment of participants to receive

Who is the study for?
This trial is for kids and teens who have been diagnosed with bipolar I or II disorder and are currently going through a major depressive episode. They must meet the specific diagnostic criteria outlined in a specialized interview called K-SADS-PL.
What is being tested?
The study tests Lumateperone, a new potential treatment for bipolar depression in young people, against a placebo (a substance with no active drug). Participants will be randomly assigned to either group without knowing which one they're in.
What are the potential side effects?
While not specified here, common side effects of psychiatric drugs like Lumateperone may include drowsiness, weight gain, nausea, restlessness or agitation. Each person's reaction can vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 13 and 17 years old.
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I have been diagnosed with bipolar disorder and am currently experiencing a major depressive episode without psychosis.
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I have had at least one episode of mania or hypomania in my life.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My depression score improved by 25% or was below 45 at the start.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Children's Depression Rating Scale-Revised (CDRS-R)
Secondary study objectives
Clinical Global Impression Scale-Severity (CGI-S)

Side effects data

From 2019 Phase 3 trial • 381 Patients • NCT03249376
18%
Headache
9%
Somnolence
6%
Nauseau
5%
Dizziness
1%
Mania
100%
80%
60%
40%
20%
0%
Study treatment Arm
Lumateperone
Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: LumateperoneExperimental Treatment1 Intervention
Lumateperone 42 mg for patient ages 13-17 years and Lumateperone 21 mg for patient ages 10-12 years.
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lumateperone
2021
Completed Phase 3
~1360

Find a Location

Who is running the clinical trial?

Intra-Cellular Therapies, Inc.Lead Sponsor
37 Previous Clinical Trials
9,340 Total Patients Enrolled
~256 spots leftby Apr 2027
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