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

NCT06951698 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 274

Last updated 2026-04-14

No results posted yet for this study

Summary

The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder

Conditions

  • Bipolar-I Disorder With Mania or Mania With Mixed Features

Interventions

OTHER

Placebo

Specified dose on specified days

DRUG

KarXT

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
2025-06-11
Primary Completion
2026-11-01
Completion
2026-11-01
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Bulgaria
  • Hungary
  • Japan
  • New Zealand
  • Poland

Study Locations

More Related Trials

Entities

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 NCT06951698 on ClinicalTrials.gov