A Phase 3 interventional study of KarXT and Lithium in Bipolar Disorder Type I With Mania, sponsored by Bristol-Myers Squibb. Recruiting at 184 sites in 20 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment
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.
166 studies on the registry are indexed under Mania; 13 are open to participants now.
This study's planned enrollment of 450 is above the median of 89 across 138 interventional studies indexed under Mania.
Browse Mania studies →Bristol-Myers Squibb is the lead sponsor of 1,561 studies on the registry; 117 are open to participants now.
Of its 436 completed or terminated interventional studies of FDA-regulated products, 228 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: KarXT · Drug: Lithium · Drug: Valproate · Drug: Lamotrigine
Drug pages: Xanomeline · Trospium
Specified dose on specified days
Also known as: BMS-986510, Xanomeline and trospium chloride
Therapeutic dose
Therapeutic dose
Therapeutic dose
Number of participants with treatment emergent adverse events (TEAEs)
Time frame: Up to week 54
Number of participants with AEs of special interest (AESIs)
Time frame: Up to week 54
Number of participants with serious AEs (SAEs)
Time frame: Up to week 54
Number of participants with TEAEs leading to treatment discontinuation
Time frame: Up to week 52
Number of participants with change in suicidal ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to week 54
Change from baseline in Barnes Akathisia Rating Scale (BARS) score
Time frame: Up to week 54
Change from baseline in Simpson Angus Scale (SAS) score
Time frame: Up to week 54
Change from baseline in Abnormal Involuntary Movement Scale (AIMS) score
Time frame: Up to week 54
Change from baseline in International Prostate Symptom Score (IPSS)
Only for males ≥ 45 years of age
Time frame: Up to week 54
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Showing the first 100 of 184 sites across 20 countries. Choose a country and city above to see the rest.
Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: See Plan Description
Access criteria: See Plan Description
Data sharing details ↗ · www.bms.com
Started Jul 2025 (actual). Primary completion is estimated for Jun 2028, 34 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drugs tested here: Xanomeline · Trospium