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

Recruiting · NCT07140913 · Interventional (participants receive a specific treatment) · Lead sponsor: Bristol-Myers Squibb

View the official record on ClinicalTrials.gov →

Bipolar Disorder

Interventions studied

PlaceboXanomeline/Trospium Chloride

What this trial is about

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.

Who can take part

Age range

18 Years to 65 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

60 locations listed across 8 US states.

Pillar Clinical Research - Bentonville - Bentonville, Arkansas, United States
Pillar Clinical Research- Little Rock - Little Rock, Arkansas, United States
Clinical Innovations, Inc. dba CITrials - Bellflower, California, United States
Inland Psychiatric Medical Group. - Chino, California, United States
Proscience Research Group - Culver City, California, United States
Omega Clinical Trials - La Habra - La Habra, California, United States
Catalina Research Institute, LLC - Montclair, California, United States
NRC Research Institute - Orange, California, United States
Clinical Innovations, Inc. dba CITrials - Riverside, California, United States
Velocity Clinical Research, Hallandale Beach - Hallandale, Florida, United States
South Florida Research Phase I-IV - Miami, Florida, United States
Health Synergy Clinical Research - West Palm Beach, Florida, United States
CenExel iResearch, LLC - Savannah, Georgia, United States
Pillar Clinical Research -Chicago - Chicago, Illinois, United States
Arch Clinical Trials - St Louis, Missouri, United States
Richmond Behavioral Associates - Staten Island, New York, United States
Community Clinical Research - Austin, Texas, United States
Elevate Clinical Research-Houston - Houston, Texas, United States
Prime Clinical Research - Mansfield - Mansfield, Texas, United States
Pillar Clinical Research - Richardson - Richardson, Texas, United States
Local Institution - 0004 - Ancona, Italy
Institutul Național de Gerontologie și Geriatrie "Ana Aslan" - Bucharest, Romania
Local Institution - 0099 - Bucharest, Romania
Local Institution - 0203 - Bucharest, Romania
Local Institution - 0195 - Changsha, China
Local Institution - 0010 - Córdoba, Argentina
Local Institution - 0012 - Córdoba, Argentina
Local Institution - 0008 - Córdoba, Argentina
Kuramitsu Hospital - Fukuoka, Japan
Local Institution - 0002 - Genova, Italy
Local Institution - 0091 - Glostrup Municipality, Denmark
Local Institution - 0097 - Iași, Romania
Local Institution - 0083 - Jerusalem, Israel
Kochi Health Sciences Center - Kochi, Japan
Local Institution - 0116 - Kolkata, India
Local Institution - 0087 - Marseille, France
Local Institution - 0009 - Mendoza, Argentina
Local Institution - 0129 - Montpellier, France
State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar - Novi Iskar, Bulgaria
Local Institution - 0171 - Odesa, Ukraine
Local Institution - 0089 - Paris, France
"University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD - Pleven, Bulgaria
Local Institution - 0177 - Poltava, Ukraine
Spitalul de Psihiatrie și Neurologie Brașov - Sanpetru /Brasov, Romania
Local Institution - 0114 - Santiago del Estero, Argentina
Local Institution - 0101 - Sibiu, Romania
Local Institution - 0181 - Sliven, Bulgaria
Local Institution - 0086 - Targovishte, Bulgaria
Local Institution - 0206 - Ternopil, Ukraine
Clinica Inventiva - Tuszyn, Poland
Okehazama Hospital - Toyoake, Aichi-ken, Japan
Local Institution - 0126 - Nice, Alpes-Maritimes, France
Local Institution - 0185 - Beijing, Beijing Municipality, China
Local Institution - 0190 - Beijing, Beijing Municipality, China
Local Institution - 0093 - Bucharest, Bucharest, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital - Bucharest, Bucharest, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital - Bucharest, Bucharest, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital - Bucharest, Bucharest, Romania
Prof. Dr. Alexandru Obregia Psychiatry Hospital - Bucharest, Bucharest, Romania
Local Institution - 0011 - ABB, Buenos Aires F.D., Argentina

Showing 60 of 104 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →