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NCT06951711RECRUITINGIRB Ready

A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)

Sponsored by Bristol-Myers Squibb

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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 Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features. The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in treating symptoms of mania during a 3-week inpatient period. The duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.

Who Can Participate

Inclusion Criteria

Participants must have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation.
Participants must be experiencing an acute episode or relapse of mania or mania with mixed features (โ‰ค 3 weeks).
Participants must require hospitalization for the acute exacerbation or relapse of mania.
Participants must have all psychotropic medications washed out in no more than 14 days prior to the first dose of the study drug.
Participants must have a Young Mania Rating Scale (YMRS) score of โ‰ฅ 20 at Screening and at Baseline.
Participants must have a Clinical Global Impressions-Bipolar (CGI-BP) โ‰ฅ 4 at Screening and at Baseline.

Exclusion Criteria

Participants must not have any primary Diagnostic and Statistical Manual of Mental Disorders (5th Edition, Text Revision) (DSM-5-TR) disorder, other than BP-I with mania or mania with mixed features within 12 months before screening, including BP-I with depression (for previous 3 mont

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

Study Details

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Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

274 participants

๐ŸŽ‚

Age Range

18 Years - 65 Years

โšง

Gender

ALL

๐Ÿข

Sponsor

Bristol-Myers Squibb

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Little Rock

Arkansas

Location available
View Little Rock location page
RECRUITING

Rogers

Arkansas

Location available
View Rogers location page
RECRUITING

Culver City

California

Location available
View Culver City location page
RECRUITING

Riverside

California

Location available
View Riverside location page
RECRUITING

Torrance

California

Location available
View Torrance location page
WITHDRAWN

Hialeah Gardens

Florida

Location available
View Hialeah Gardens location page
RECRUITING

Hollywood

Florida

Location available
View Hollywood location page
RECRUITING

Miami

Florida

Location available
View Miami location page
RECRUITING

Miami Lakes

Florida

Location available
View Miami Lakes location page

๐Ÿ“ And 18 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

Looking for Bipolar Disorder Treatment in Little Rock?

Join others in Arkansas exploring innovative treatment options through clinical research

Bipolar Disorder Treatment Options in Little Rock, Arkansas

If you're searching for Bipolar Disorder treatment in Little Rock, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Little Rock, Rogers, Culver City 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 Disorder. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Arkansas
Now Enrolling
Up to 274 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Bipolar Disorder?

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 Disorder

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 Disorder 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: NCT06951711. 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.