A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)

Bristol-Myers Squibb

Summary

This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I) The primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.

Eligibility

Age range: 18–65 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046): a. Participants must have completed treatment period of parent study. * De novo participants who did not participate in double-blind placebo-controlled studies: 1. Participants must have primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI, v7.0.2), with symptoms of mania or mixed mania. 2. Participants must have Youn…

Interventions

Drug
KarXT
Specified dose on specified days
Drug
Lithium
Therapeutic dose
Drug
Valproate
Therapeutic dose
Drug
Lamotrigine
Therapeutic dose

Locations (182)

Local Institution - 0120
Glendale, Arizona
Local Institution - 0204
Scottsdale, Arizona
Local Institution - 0205
Tucson, Arizona
Pillar Clinical Research - Richardson
Bentonville, Arkansas
479-367-2688
Pillar Clinical Research- Little Rock
Little Rock, Arkansas
501-350-3285
Woodland International Research Group
Little Rock, Arkansas
501-221-8681