Bipolar Disorder Type I With Mania
Conditions
Keywords
Bipolar-I disorder, Mania, Bipolar-I disorder with Mania
Brief 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.
Interventions
DRUGKarXT
Specified dose on specified days
DRUGLithium
Therapeutic dose
DRUGValproate
Therapeutic dose
DRUGLamotrigine
Therapeutic dose
Sponsors
Bristol-Myers Squibb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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 Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline. 3. Participants must have CGI-BP score of ≥ 3 at Screening and at baseline. 4. Participants does not require hospitalization for acute mania.
Exclusion criteria
* All participants: 1\. All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as assessed on C-SSRS. * Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046): 1\. Discontinuation from any KarXT parent studies. * De novo participants who did not participate in double-blind placebo-controlled studies: 1. Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year). 2. Participants must not have any primary DSM-5-TR disorder other than BP-I with mania or mania with mixed features within 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), including BP-I with depression, (previous 3 months only), Bipolar-II disorder, major depressive disorder, borderline personality disorder, and primary psychotic disorder, with the exception of mild anxiety disorders. 3. Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), or current use as determined by urine toxicology screen or alcohol test. 4. Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months. 5. Participants must not have history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma. * Other protocol-defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with treatment emergent adverse events (TEAEs) | Up to week 54 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with AEs of special interest (AESIs) | Up to week 54 | — |
| Number of participants with serious AEs (SAEs) | Up to week 54 | — |
| Number of participants with TEAEs leading to treatment discontinuation | Up to week 52 | — |
| Number of participants with change in suicidal ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) | Up to week 54 | — |
| Change from baseline in Barnes Akathisia Rating Scale (BARS) score | Up to week 54 | — |
| Change from baseline in Simpson Angus Scale (SAS) score | Up to week 54 | — |
| Change from baseline in Abnormal Involuntary Movement Scale (AIMS) score | Up to week 54 | — |
| Change from baseline in International Prostate Symptom Score (IPSS) | Up to week 54 | Only for males ≥ 45 years of age |
Countries
Argentina, Australia, Bulgaria, China, Croatia, Denmark, France, Hungary, India, Israel, Italy, Japan, New Zealand, Poland, Romania, Slovakia, Spain, Sweden, Ukraine, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed