A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
Status: Recruiting
Location: See all (68) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arkansas
Pillar Clinical Research- Little Rock
RECRUITING
Little Rock
Woodland Research Northwest
RECRUITING
Rogers
California
Proscience Research Group
RECRUITING
Culver City
Clinical Innovations, Inc. dba CITrials
RECRUITING
Riverside
Collaborative Neuroscience Research, LLC
RECRUITING
Torrance
Florida
Local Institution - 0036
WITHDRAWN
Hialeah Gardens
Behavioral Clinical Research
RECRUITING
Hollywood
LCC Medical Research Institute
RECRUITING
Miami
Innovative Clinical Research, Inc.
RECRUITING
Miami Lakes
South Florida Research Phase I-IV
RECRUITING
Miami Springs
Local Institution - 0019
WITHDRAWN
Tampa
Georgia
Atlanta Center for Medical Research
RECRUITING
Atlanta
CenExel iResearch, LLC
RECRUITING
Decatur
Illinois
Local Institution - 0020
NOT_YET_RECRUITING
Chicago
Maryland
CBH Health
RECRUITING
Gaithersburg
Missouri
Arch Clinical Trials
RECRUITING
St Louis
Mississippi
Local Institution - 0017
NOT_YET_RECRUITING
Flowood
North Carolina
Local Institution - 0075
NOT_YET_RECRUITING
Charlotte
New Jersey
Hassman Research Institute Marlton Site
RECRUITING
Marlton
Local Institution - 0031
WITHDRAWN
Marlton
Nevada
Local Institution - 0076
WITHDRAWN
North Las Vegas
Ohio
University of Cincinnati Medical Center
RECRUITING
Cincinnati
Neuro-Behavioral Clinical Research
RECRUITING
North Canton
Texas
InSite Clinical Research
RECRUITING
Desoto
Local Institution - 0028
NOT_YET_RECRUITING
Houston
Pillar Clinical Research - Richardson
RECRUITING
Richardson
Other Locations
Croatia
Local Institution - 0008
NOT_YET_RECRUITING
Zagreb
Local Institution - 0009
WITHDRAWN
Zagreb
Local Institution - 0010
NOT_YET_RECRUITING
Zagreb
Local Institution - 0063
NOT_YET_RECRUITING
Zagreb
Local Institution - 0078
NOT_YET_RECRUITING
Zagreb
India
Local Institution - 0082
NOT_YET_RECRUITING
Belagavi
Local Institution - 0052
NOT_YET_RECRUITING
Hyderabad
Local Institution - 0055
NOT_YET_RECRUITING
Hyderabad
Local Institution - 0054
NOT_YET_RECRUITING
Kolkata
Local Institution - 0053
NOT_YET_RECRUITING
Kozhikode
Local Institution - 0051
NOT_YET_RECRUITING
Ludhiana
Local Institution - 0065
NOT_YET_RECRUITING
Vadodara
Israel
Local Institution - 0066
NOT_YET_RECRUITING
Beersheba
Local Institution - 0042
NOT_YET_RECRUITING
Hod Hasharon
Local Institution - 0045
NOT_YET_RECRUITING
Jerusalem
Local Institution - 0046
NOT_YET_RECRUITING
Ness Ziona
Local Institution - 0058
NOT_YET_RECRUITING
Petah Tikva
Sheba Medical Center
RECRUITING
Ramat Gan
Italy
Local Institution - 0041
WITHDRAWN
Ancona
Local Institution - 0040
WITHDRAWN
Genova
Local Institution - 0001
WITHDRAWN
Milan
Local Institution - 0056
WITHDRAWN
Pisa
Local Institution - 0007
WITHDRAWN
Siena
Romania
Local Institution - 0048
NOT_YET_RECRUITING
Bucharest
Local Institution - 0049
NOT_YET_RECRUITING
Bucharest
Local Institution - 0057
NOT_YET_RECRUITING
Bucharest
Local Institution - 0060
NOT_YET_RECRUITING
Bucharest
Local Institution - 0062
NOT_YET_RECRUITING
Bucharest
Local Institution - 0064
NOT_YET_RECRUITING
Bucharest
Prof. Dr. Alexandru Obregia Psychiatry Hospital
RECRUITING
Bucharest
Prof. Dr. Alexandru Obregia Psychiatry Hospital
RECRUITING
Bucharest
Local Institution - 0047
NOT_YET_RECRUITING
Iași
Local Institution - 0061
NOT_YET_RECRUITING
Sanpetru /brasov
Slovakia
Local Institution - 0071
NOT_YET_RECRUITING
Košice
Local Institution - 0073
NOT_YET_RECRUITING
Košice
Local Institution - 0072
NOT_YET_RECRUITING
Vranov Nad Topľou
Spain
Hospital Clínic de Barcelona
RECRUITING
Barcelona
Local Institution - 0069
NOT_YET_RECRUITING
Barcelona
Osi Bilbao-Basurto
RECRUITING
Bilbao
Sweden
Local Institution - 0070
WITHDRAWN
Gothenburg
Local Institution - 0077
NOT_YET_RECRUITING
Nacka
Local Institution - 0067
WITHDRAWN
Uppsala
Contact Information
Primary
BMS Study Connect www.BMSStudyConnect.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain the NCT# and Site #.