A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

Purpose

The purpose of this study is to evaluate the efficacy and safety of adjunctive KarXT for the treatment of mania in participants with Bipolar-I Disorder.

Conditions

  • Mania
  • Bipolar Disorder

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Individuals have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on the DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) version 7.0.2 Standard. - Individual is experiencing an acute exacerbation or relapse of manic episode, with or without mixed features (≤ 3 weeks). - The individual requires hospitalization for the acute exacerbation or relapse of mania. - Body mass index ≥ 18 and ≤ 40 kg/m2 - Currently experiencing an acute episode of mania or mania with mixed features with a therapeutic dose of lithium, valproate, or lamotrigine. The dose of the mood stabilizer must have remained stable for at least two weeks prior to screening. Additionally, participants on valproate must have been receiving treatment with valproate for a minimum of seven months. - YMRS Total Score of ≥ 18 at Screening and at Baseline, and < 20% reduction in YMRS from screening to baseline. - Clinical Global Impression Severity scale (CGI-BP) ≥ 4

Exclusion Criteria

  • Any primary DSM-5-TR disorder other than BP-I within 12 months before screening (confirmed using MINI version 7.0.2 Standard) including BP-I depression, BP-I with rapid cycling, first manic episode, BP-II, and major depressive disorder. - 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 Standard at screening), or current use as determined by urine toxicology screen or alcohol test. - Risk for suicidal behavior at screening as determined by the investigator's clinical assessment and the C-SSRS with an answer "Yes" to item 4 or 5 within 6 months before screening or between screening and baseline, or suicide attempt within 12 months before screening, or between screening and baseline - History of irritable bowel syndrome (with or without constipation) or any serious constipation requiring treatment within the last 6 months. - History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma. - Participants with HIV, cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on either medical history or the LFT results. - Elevations in hepatic transaminases at screening ≥ 2 × ULN for ALT and AST and/or bilirubin > 1.5× ULN, unless in the context of Gilbert's syndrome. - All grades of hepatic impairment (mild [Child-Pugh Class A], moderate [Child-Pugh Class B], and severe [Child-Pugh Class C]). - Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
KarXT + Lithium, Valproate, or Lamotrigine
  • Drug: Xanomeline/Trospium Chloride
    Specified dose on specified days
    Other names:
    • KarXT
    • BMS-986510
  • Drug: Lithium
    Specified dose on specified days
  • Drug: Valproate
    Specified dose on specified days
  • Drug: Lamotrigine
    Specified dose on specified days
Placebo Comparator
Placebo + Lithium, Valproate, or Lamotrigine
  • Drug: Lithium
    Specified dose on specified days
  • Drug: Valproate
    Specified dose on specified days
  • Drug: Lamotrigine
    Specified dose on specified days
  • Drug: Placebo
    Specified dose on specified days

Recruiting Locations

Pillar Clinical Research - Bentonville
Bentonville 4101260, Arkansas 4099753 72712
Contact:
Fayz Hudefi, Site 0029
479-367-2688

Pillar Clinical Research- Little Rock
Little Rock 4119403, Arkansas 4099753 72204
Contact:
Leslie Smith, Site 0018
501-350-3285

Inland Psychiatric Medical Group - Chino
Chino 5336537, California 5332921 91710
Contact:
Nandita Puchakayala, Site 0049
909-488-9116

South Florida Research Phase I-IV
Miami Springs 4164223, Florida 4155751 33166
Contact:
Silvia Silva Duluc, Site 0021
305-669-6166

Health Synergy Clinical Research
Stuart 4174201, Florida 4155751 34997
Contact:
Mohammad Nisar, Site 0016
786-831-7303

CenExel iResearch, LLC
Savannah 4221552, Georgia 4197000 31405
Contact:
Yael Elfassy, Site 0136
912-744-0800

Pillar Clinical Research -Chicago
Chicago 4887398, Illinois 4896861 60641
Contact:
Roueen Rafeyan, Site 0017
312-865-6336

Pillar Clinical Research - Richardson
Richardson 4722625, Texas 4736286 75080
Contact:
Scott Bartley, Site 0033
214-396-4844

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com