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Lumateperone for Depression, Bipolar Disorder

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 6

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 6

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Children's Depression Rating Scale-Revised (CDRS-R)

Secondary outcome measures

Clinical Global Impression Scale-Severity (CGI-S)

Side effects data

From 2019 Phase 3 trial • 381 Patients • NCT03249376

18%

Headache

Somnolence

Nauseau

Dizziness

Mania

100%

80%

60%

40%

20%

Study treatment Arm

Lumateperone

Placebo

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Intra-Cellular Therapies, Inc.Lead Sponsor

30 Previous Clinical Trials

7,147 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Lumateperone received official endorsement from the FDA?

"Considering that this trial is in Phase 3, which implies the existence of efficacy data as well as multiple rounds of safety data, our team at Power rates Lumateperone's safety level as 3 on a scale from 1 to 3."

Answered by AI

At present, how many locations are hosting this particular clinical trial?

"The trial is ongoing at 27 sites, including Indianapolis, Lincoln, Anaheim, and other undisclosed locations. It is advisable to choose a site in close proximity to minimize travel obligations post-enrollment."

Answered by AI

What are the criteria for individuals who meet the requirements to participate in this research study?

"Individuals aged between 10 and 17 years old diagnosed with bipolar depression are eligible to participate in this study. The target recruitment for this trial is approximately 384 participants."

Answered by AI

Are patients currently able to enroll in this ongoing study?

"As per the details available on clinicaltrials.gov, this investigation is actively in pursuit of eligible participants. The trial was initially made public on April 1st, 2024, and its latest update was recorded on April 15th, 2024."

Answered by AI

How many participants are currently undergoing treatment in this medical study?

"Indeed, data available on clinicaltrials.gov affirms that this study is actively seeking participants. It was initially listed on April 1st, 2024, and underwent its most recent update on April 15th of the same year. The trial aims to enroll a total of 384 individuals distributed among 27 different sites."

Answered by AI