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. - 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.

Exclusion Criteria

  • Any primary DSM-5-TR disorder other than BP-I within 12 months before screening (confirmed using MINI version 7.0.2 at screening) including BP-I depression (for previous 3 months only), BP-I with rapid cycling, first manic episode, BP-II, primary psychotic disorder, borderline personality disorder, and major depressive disorder, with the exception of mild anxiety disorders. - 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. - 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 "Yes" to any of the 5 items (C-SSRS behavior) with an event occurring within the 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 or 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
Placebo Comparator
Placebo + Lithium, Valproate, or Lamotrigine
  • Drug: Placebo
    Specified dose on specified days

Recruiting Locations

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

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

Clinical Innovations, Inc. dba CITrials
Bellflower, California 90706
Contact:
Gerald Maguire, Site 0110
562-249-6956

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

Proscience Research Group
Culver City, California 90230
Contact:
Marina Bussel, Site 0014
424-227-8127

Omega Clinical Trials - La Habra
La Habra, California 90631
Contact:
Wakelin McNeel, Site 0151
562-690-2200

Catalina Research Institute, LLC
Montclair, California 91763
Contact:
Stephen Volk, Site 0037
909-590-8409

NRC Research Institute
Orange, California 92868
Contact:
Tony Ortiz, Site 0148
714-289-1100

Clinical Innovations, Inc. dba CITrials
Riverside, California 92506
Contact:
Evagelos Coskinas, Site 0106
951-300-4924

Velocity Clinical Research, Hallandale Beach
Hallandale, Florida 33009
Contact:
Beth Safirstein, Site 0015

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

Health Synergy Clinical Research
West Palm Beach, Florida 33407
Contact:
Mohammad Nisar, Site 0016
786-831-7303

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

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

Arch Clinical Trials
St Louis, Missouri 63141
Contact:
Junaid Syed, Site 0023
314-771-6387

Richmond Behavioral Associates
Staten Island, New York 10314
Contact:
Peter Weiden, Site 0032
917-701-7484

Community Clinical Research
Austin, Texas 78754
Contact:
David Brown, Site 0026
512-323-2622

Prime Clinical Research - Mansfield
Mansfield, Texas 76063
Contact:
Jamie Alexander, Site 0156
817-907-7330

Pillar Clinical Research - Richardson
Richardson, Texas 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