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)

Trial status: Authorised To monitor for: serious side effects, specific side effects of concern, side effects that cause participants to stop treatment., To observe any changes in how participants respond to questions about suicidal thoughts or behaviors., To measure changes from the beginning of the study in: Movement and coordination (using tests like BARS, SAS, and AIMS); Urinary symptoms (for male participants aged 45 and older, using the IPSS questionnaire). To track any side effects that participants experience while receiving the treatment.

To monitor for: serious side effects, specific side effects of concern, side effects that cause participants to stop treatment., To observe any changes in how participants respond to questions about suicidal thoughts or behaviors., To measure changes from the beginning of the study in: Movement and coordination (using tests like BARS, SAS, and AIMS); Urinary symptoms (for male participants aged 45 and older, using the IPSS questionnaire).

Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 148 participants