A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)

PHASE3RecruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

August 8, 2025

Primary Completion Date

June 30, 2028

Study Completion Date

August 31, 2028

Conditions
Bipolar DisorderBipolar DepressionBipolar I DisorderBipolar II Disorder
Interventions
DRUG

Azetukalner

Azetukalner 20 mg taken orally once a day with food (with the evening meal when possible) for 6 weeks

DRUG

Placebo

Placebo taken orally once a day with food (with the evening meal when possible) for 6 weeks

Trial Locations (9)

32256

RECRUITING

Clinical Neuroscience Solutions, Inc., Jacksonville

32801

RECRUITING

Clinical Neuroscience Solutions, Inc, Orlando

33146

RECRUITING

PharmaSouth Research, LLC, Coral Gables

38119

RECRUITING

Clinical Neuroscience Solutions, Inc, Memphis

72211

RECRUITING

Woodland International Research Group, Little Rock

72758

RECRUITING

Woodland Research Northwest, Rogers

76309

RECRUITING

Grayline Research Center, Wichita Falls

92866

RECRUITING

ATP Clinical Research, Orange

08002

RECRUITING

Center For Emotional Fitness, Cherry Hill

All Listed Sponsors
lead

Xenon Pharmaceuticals Inc.

INDUSTRY