A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
Recruiting · NCT06951698 · Interventional (participants receive a specific treatment) · Lead sponsor: Bristol-Myers Squibb
View the official record on ClinicalTrials.gov →Interventions studied
KarXTPlacebo
What this trial is about
The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in 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
- Participants must have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation.
- Participants must be experiencing an acute episode or relapse of mania or mania with mixed features (≤ 3 weeks).
- Participants must require hospitalization for the acute exacerbation or relapse of mania.
- Participants must have all psychotropic medications washed out in no more than 14 days prior to the first dose of the study drug.
- Participants must have a Young Mania Rating Scale (YMRS) score of ≥ 20 at Screening and at Baseline.
- Participants must have a Clinical Global Impressions-Bipolar (CGI-BP) ≥ 4 at Screening and at Baseline.
Exclusion criteria
- Participants must not have any primary Diagnostic and Statistical Manual of Mental Disorders (5th Edition, Text Revision) (DSM-5-TR) disorder, other than BP-I with mania or mania with mixed features within 12 months before screening, including BP-I with depression (for previous 3 months only), BP-II disorder, borderline personality disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.
- Participants must not have a primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year).
- Participants must not have a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening, or current use as determined by urine toxicology screen or alcohol test.
- Participants must not be at risk for suicidal behavior at screening or the baseline visit as determined by the Investigator's clinical assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS).
- Participants must not have a history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
- Participants must not have a history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Where it is running
60 locations listed across 9 US states.
- Local Institution - 0058 - Bentonville, Arkansas, United States
- Woodland International Research Group - Little Rock, Arkansas, United States
- Advanced Research Center Inc. - Anaheim, California, United States
- CITrials - Bellflower, California, United States
- Local Institution - 0014 - Cerritos, California, United States
- Collaborative Neuroscience Research, LLC - Long Beach, California, United States
- NRC Research Institute - Los Angeles, California, United States
- Catalina Research Institute, LLC - Montclair, California, United States
- Connecticut Mental Health Center - New Haven, Connecticut, United States
- Research Centers of America ( Hollywood ) - Hollywood, Florida, United States
- Advanced Research Institute of Miami - Homestead, Florida, United States
- South Florida Research Phase I-IV - Miami, Florida, United States
- Innovative Clinical Research, Inc. - Miami Lakes, Florida, United States
- Local Institution - 0015 - Miami Lakes, Florida, United States
- Health Synergy Clinical Research - West Palm Beach, Florida, United States
- Synexus Clinical Research US, Inc. - Atlanta, Georgia, United States
- CenExel iResearch, LLC - Savannah, Georgia, United States
- Pillar Clinical Research -Chicago - Chicago, Illinois, United States
- Richmond Behavioral Associates - Staten Island, New York, United States
- Neuro-Behavioral Clinical Research - North Canton, Ohio, United States
- Local Institution - 0141 - Austin, Texas, United States
- Local Institution - 0029 - Irving, Texas, United States
- Pillar Clinical Research - Richardson - Richardson, Texas, United States
- North Shore Hospital - Auckland, New Zealand
- Semmelweis Egyetem - Budapest, Hungary
- Nyírő Gyula Országos Pszichiátriai és Addiktológiai Intézet - Budapest, Hungary
- Center for Mental Health Prof. Dr. Ivan Temkov - Burgas, Bulgaria
- Sanatorio Morra S.A. - Córdoba, Argentina
- Local Institution - 0130 - Dnipro, Ukraine
- Kuramitsu Hospital - Fukuoka, Japan
- Local Institution - 0139 - Haskovo, Bulgaria
- Local Institution - 0126 - Kropyvnytskyi, Ukraine
- Local Institution - 0129 - Kyiv, Ukraine
- Local Institution - 0109 - Mendoza, Argentina
- Miyazaki Prefectural Miyazaki Hospital - Miyazaki, Japan
- State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar - Novi Iskar, Bulgaria
- Osaka Metropolitan University Hospital - Osaka, Japan
- Local Institution - 0084 - Osaka, Japan
- "University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD - Pleven, Bulgaria
- Local Institution - 0132 - Poltava, Ukraine
- Local Institution - 0140 - Santiago del Estero, Argentina
- MHAT "Dr. Ival Seliminski" - Sliven, Bulgaria
- Local Institution - 0137 - Ternopil, Ukraine
- Showa Medical University Karasuyama Hospital - Tokyo, Japan
- Clinica Inventiva - Tuszyn, Poland
- Mental Health Center - Vratsa - Vratsa, Bulgaria
- Wakayama Medical University Hospital - Wakayama, Japan
- Yamagata Sakuracho Hospital - Yamagata, Japan
- Local Institution - 0082 - Kōnan, Aichi-ken, Japan
- Okehazama Hospital - Toyoake, Aichi-ken, Japan
- Hospital Italiano de Buenos Aires - ABB, Buenos Aires F.D., Argentina
- Local Institution - 0131 - Smila, Cherkasy Oblast, Ukraine
- National Kohnodai Medical Center. - Ichikawa, Chiba, Japan
- Local Institution - 0100 - Kitakyushu, Fukuoka, Japan
- Centrum Medyczne HCP - Poznan, Greater Poland Voivodeship, Poland
- Petz Aladar Egyetemi Oktato Korhaz - Győr, Győr-Moson-Sopron, Hungary
- Obihiro Kosei Hospital - Obihiro, Hokkaido, Japan
- Goryokai Medical Corporation - Goryokai Hospital - Sapporo, Hokkaido, Japan
- Local Institution - 0133 - Skarzhyntsi, Khmelnytskyi Oblast, Ukraine
- Instytut Psychiatrii i Neurologii - Warsaw, Masovian Voivodeship, Poland
Showing 60 of 74 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →