A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals with Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521845-26-00

Acronym

CN012-0046

Enrollment

185

Registered

2026-01-15

Start date

Unknown

Completion date

Unknown

Last updated

2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BP-I mania or mania with mixed features

Brief summary

Change from baseline in Young Mania Rating Scale (YMRS, used to evaluate manic symptoms) score at Week 5.

Detailed description

Change from baseline in CGI-BP (used to evaluate daily functioning) at Week 5.

Interventions

DRUGKarXT Matching Placebo

DRUGKarXT

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Change from baseline in Young Mania Rating Scale (YMRS, used to evaluate manic symptoms) score at Week 5.	—

Secondary

Measure	Time frame
Change from baseline in CGI-BP (used to evaluate daily functioning) at Week 5.	—

Countries

Bulgaria, Denmark, France, Italy, Poland, Romania

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026