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
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
- DrugKarXT
Specified dose on specified days
- DrugLithium
Therapeutic dose
- DrugValproate
Therapeutic dose
- DrugLamotrigine
Therapeutic dose
Locations (170)
- Local Institution - 0120Glendale, Arizona
- Pillar Clinical Research - RichardsonBentonville, Arkansas
- Pillar Clinical Research- Little RockLittle Rock, Arkansas
- Woodland International Research GroupLittle Rock, Arkansas
- Woodland Research NorthwestRogers, Arkansas
- Advanced Research Center Inc.Anaheim, California