Image

A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)

Examining KarXT's safety for treating manic episodes in Bipolar-I.

Recruiting
18-65 years
All
Phase 3
This study aims to determine the long-term safety of a medication called **KarXT** for treating manic episodes in people with **Bipolar-I Disorder**. Manic episodes are periods of extremely high energy, mood swings, and erratic behavior. **KarXT** is a drug being tested to see how well patients tolerate it over time. To join the study, participants must have either taken part in a previous related study or be newly diagnosed with Bipolar-I Disorder. The disorder must be confirmed through evaluations, and participants should have specific scores on the **Young Mania Rating Scale (YMRS)** and **Clinical Global Impressions for Bipolar Disorder (CGI-BP)**. Certain conditions, like a high risk of suicidal behavior or other severe mental disorders, may disqualify participation. Key Points:
  • The study is open-label, meaning both doctors and participants know they are receiving KarXT.
  • Participants must not have severe constipation or other risk factors like urinary retention.
  • Participants cannot be at high risk of suicide or have certain other psychiatric disorders.
Study details
    Bipolar Disorder Type I With Mania

NCT06929273

Bristol-Myers Squibb

7 March 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Race
Ethnicity
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.