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A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 424

Last updated 2026-04-30

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of adjunctive KarXT for the treatment of mania in participants with Bipolar-I Disorder.

Conditions

Interventions

DRUG

Xanomeline/Trospium Chloride

Specified dose on specified days

DRUG

Placebo

Specified dose on specified days

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-08
Primary Completion
2027-06-28
Completion
2027-06-28
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Bulgaria
  • China
  • Denmark
  • France
  • India
  • Israel
  • Italy
  • Japan
  • Poland
  • Romania
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07140913 on ClinicalTrials.gov