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

Sponsored by Intra-Cellular Therapies, Inc.

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...

Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified Jul 8, 2025

Phase

Clinical Trial

Sponsor

Intra-Cellular Therapies, Inc.

Enrollment Target

384

Start Date

May 2024

๐Ÿ“Š
1 of 384 participants interested
0% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

This is a multicenter, randomized, double-blind, placebo-controlled 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).

Who Can Participate

Inclusion Criteria

Able to provide consent as follows:
The Legally Authorized Representative (LAR) must provide written, informed consent.
The patient must provide written assent; 2. Male or female patients 10 to 17 years of age, inclusive; 3. 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 Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL); 4. Subject has a lifetime history of at least one manic or hypomanic episode. 5. Subject's current major depressive episode is โ‰ฅ 4 weeks and less than 12 months in duration; 6. CDRS-R total score โ‰ฅ 45 with โ‰ฅ 5 on Item 11 (depressed feelings) at Screening and Baseline; 7. Young Mania Rating Scale (YMRS) score โ‰ค 15 (with YMRS Item 1 \[elevated mood\] score โ‰ค 2) at Screening and Baseline.

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

384 participants

๐ŸŽ‚

Age Range

10 Years - 17 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

Intra-Cellular Therapies, Inc.

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Dothan

Alabama

Location available
View Dothan location page
RECRUITING

Little Rock

Arkansas

Location available
View Little Rock location page
RECRUITING

Anaheim

California

Location available
View Anaheim location page
RECRUITING

Redlands

California

Location available
View Redlands location page
NOT_YET_RECRUITING

Sacramento

California

Location available
View Sacramento location page
RECRUITING

San Diego

California

Location available
View San Diego location page
RECRUITING

West Covina

California

Location available
View West Covina location page
RECRUITING

Colorado Springs

Colorado

Location available
View Colorado Springs location page
NOT_YET_RECRUITING

Gainesville

Florida

Location available
View Gainesville location page

๐Ÿ“ And 43 more locations available

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Find More Depression Trials by City

Browse all depression clinical trials in these cities โ€” not just this study.

Looking for Bipolar Depression Treatment in Dothan?

Join others in Alabama exploring innovative treatment options through clinical research

Bipolar Depression Treatment Options in Dothan, Alabama

If you're searching for Bipolar Depression treatment in Dothan, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Dothan, Little Rock, Anaheim and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Bipolar Depression. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 384 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Bipolar Depression?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Bipolar Depression

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Bipolar Depression Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06372964. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.