A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
Recruiting · NCT06951711 · 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
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features. The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in treating symptoms of mania during a 3-week inpatient period. The duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.
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 cirrhosis, liver cancer, clinically significant liver disease based on the liver function test results.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Where it is running
60 locations listed across 13 US states.
- Pillar Clinical Research- Little Rock - Little Rock, Arkansas, United States
- Woodland Research Northwest - Rogers, Arkansas, United States
- Proscience Research Group - Culver City, California, United States
- Clinical Innovations, Inc. dba CITrials - Riverside, California, United States
- Collaborative Neuroscience Research, LLC - Torrance, California, United States
- Local Institution - 0036 - Hialeah Gardens, Florida, United States
- Behavioral Clinical Research - Hollywood, Florida, United States
- LCC Medical Research Institute - Miami, Florida, United States
- Innovative Clinical Research, Inc. - Miami Lakes, Florida, United States
- South Florida Research Phase I-IV - Miami Springs, Florida, United States
- Local Institution - 0019 - Tampa, Florida, United States
- Health Synergy Clinical Research - West Palm Beach, Florida, United States
- Atlanta Center for Medical Research - Atlanta, Georgia, United States
- CenExel iResearch, LLC - Decatur, Georgia, United States
- Local Institution - 0020 - Chicago, Illinois, United States
- CBH Health - Gaithersburg, Maryland, United States
- Precise Research Centers - Flowood, Mississippi, United States
- Arch Clinical Trials - St Louis, Missouri, United States
- Local Institution - 0076 - North Las Vegas, Nevada, United States
- Hassman Research Institute Marlton Site - Marlton, New Jersey, United States
- Local Institution - 0031 - Marlton, New Jersey, United States
- Local Institution - 0075 - Charlotte, North Carolina, United States
- University of Cincinnati Medical Center - Cincinnati, Ohio, United States
- Neuro-Behavioral Clinical Research - North Canton, Ohio, United States
- Adams Clinical Dallas - DeSoto, Texas, United States
- Local Institution - 0028 - Houston, Texas, United States
- Pillar Clinical Research - Richardson - Richardson, Texas, United States
- Pillar Clinical Research - Richardson, Texas, United States
- Local Institution - 0041 - Ancona, Italy
- Centrul de Evaluare și Tratament a Toxicodependenței pentru Tineri Sf.Stelian - Bucharest, Romania
- Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila - Bucharest, Romania
- Local Institution - 0040 - Genova, Italy
- Local Institution - 0047 - Iași, Romania
- Kfar Shaul Mental Health Center - Jerusalem, Israel
- Local Institution - 0084 - Kropyvnytskyi, Ukraine
- Local Institution - 0094 - Odesa, Ukraine
- Local Institution - 0090 - Poltava, Ukraine
- Spitalul de Psihiatrie și Neurologie Brașov - Sanpetru /Brasov, Romania
- Klinika za psihijatriju "Vrapče" - Zagreb, Croatia
- Klinika za psihijatriju "Vrapče" - Zagreb, Croatia
- Klinika za psihijatriju "Vrapče" - Zagreb, Croatia
- Psihijatrijska bolnica "Sveti Ivan" - Zagreb, Croatia
- Local Institution - 0069 - Barcelona, Barcelona [Barcelona], Spain
- Local Institution - 0039 - Bilbao, Basque Country, Spain
- Local Institution - 0103 - Beijing, Beijing Municipality, China
- Local Institution - 0106 - Beijing, Beijing Municipality, China
- 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
- Prof. Dr. Alexandru Obregia Psychiatry Hospital - Bucharest, Bucharest, Romania
- Prof. Dr. Alexandru Obregia Psychiatry Hospital - Bucharest, Bucharest, Romania
- Local Institution - 0097 - Bucharest, Bucharest, Romania
- Local Institution - 0044 - Barcelona, Catalunya [Cataluña], Spain
- Shalvata Mental Health Center - Hod HaSharon, Central District, Israel
- Ness Ziona Mental Health Center - Ness Ziona, Central District, Israel
- Local Institution - 0058 - Petah Tikva, Central District, Israel
- Sheba Medical Center - Ramat Gan, Central District, Israel
- Local Institution - 0009 - Zagreb, City of Zagreb, Croatia
- Local Institution - 0088 - Dnipro, Dnipropetrovsk Oblast, Ukraine
Showing 60 of 85 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →