Image

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

Researching KarXT's effects on manic episodes in Bipolar-I Disorder.

Recruiting
18-65 years
All
Phase 3

This study is testing a new medicine called KarXT to help people with Bipolar-I disorder who are having manic episodes. Bipolar-I disorder is a mental health condition where people have extreme mood swings, including mania, which is a very "up" or excited mood. The study is "double-blind," meaning neither the doctors nor the participants know who is getting the real medicine or a placebo (a sugar pill). The study lasts up to seven weeks, including a three-week stay in a hospital setting.

To join, you must currently experience mania or mixed features, which means some symptoms of mania and depression. You can't have other major psychiatric disorders or serious substance abuse problems. The study requires stopping other mental health medications for up to 14 days before starting the test medicine.

  • Duration: Up to 7 weeks, including a 3-week hospital stay.
  • Eligibility: Must have Bipolar-I disorder with current mania.
  • Requirements: Must stop other medications before starting the study.
Study details
    Bipolar Disorder Type I With Mania or Mania With Mixed Features

NCT06951711

Bristol-Myers Squibb

17 October 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


Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Race*
Are you a healthy volunteer
Ethnicity*
Are you a healthy volunteer
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.