A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
Status: Recruiting
Location: See all (66) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• 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 Standard.
• 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.
• Clinical Global Impression Severity scale (CGI-BP) ≥ 4
Locations
United States
Arkansas
Pillar Clinical Research - Bentonville
RECRUITING
Bentonville
Pillar Clinical Research- Little Rock
RECRUITING
Little Rock
California
Local Institution - 0049
NOT_YET_RECRUITING
Chino
Local Institution - 0106
NOT_YET_RECRUITING
Costa Mesa
Local Institution - 0014
NOT_YET_RECRUITING
Culver City
Local Institution - 0151
NOT_YET_RECRUITING
La Habra
Local Institution - 0037
NOT_YET_RECRUITING
Montclair
Local Institution - 0148
NOT_YET_RECRUITING
Orange
Local Institution - 0110
NOT_YET_RECRUITING
Riverside
Florida
Local Institution - 0015
NOT_YET_RECRUITING
Hallandale
Local Institution - 0021
NOT_YET_RECRUITING
Miami Springs
Local Institution - 0016
NOT_YET_RECRUITING
Stuart
Georgia
Local Institution - 0136
NOT_YET_RECRUITING
Savannah
Illinois
Pillar Clinical Research -Chicago
RECRUITING
Chicago
Missouri
Local Institution - 0023
NOT_YET_RECRUITING
St Louis
New York
Local Institution - 0032
NOT_YET_RECRUITING
Staten Island
Texas
Local Institution - 0026
NOT_YET_RECRUITING
Austin
Local Institution - 0160
NOT_YET_RECRUITING
Beaumont
Local Institution - 0156
NOT_YET_RECRUITING
Mansfield
Pillar Clinical Research - Richardson
RECRUITING
Richardson
Other Locations
Argentina
Local Institution - 0011
NOT_YET_RECRUITING
Abb
Local Institution - 0008
NOT_YET_RECRUITING
Córdoba
Local Institution - 0010
NOT_YET_RECRUITING
Córdoba
Local Institution - 0012
NOT_YET_RECRUITING
Córdoba
Local Institution - 0009
NOT_YET_RECRUITING
Mendoza
Local Institution - 0114
NOT_YET_RECRUITING
Santiago Del Estero
Bulgaria
Local Institution - 0124
NOT_YET_RECRUITING
Novi Iskar
Local Institution - 0084
NOT_YET_RECRUITING
Pleven
Local Institution - 0125
NOT_YET_RECRUITING
Plovdiv
Local Institution - 0086
NOT_YET_RECRUITING
Targovishte
Denmark
Local Institution - 0054
NOT_YET_RECRUITING
Aalborg
Local Institution - 0091
NOT_YET_RECRUITING
Glostrup Municipality
Local Institution - 0088
NOT_YET_RECRUITING
Hillerød
France
Local Institution - 0085
NOT_YET_RECRUITING
Clermont-ferrand
Local Institution - 0087
NOT_YET_RECRUITING
Marseille
Local Institution - 0089
NOT_YET_RECRUITING
Paris
India
Local Institution - 0123
NOT_YET_RECRUITING
Madurai
Israel
Local Institution - 0053
NOT_YET_RECRUITING
Ashkelon
Local Institution - 0052
NOT_YET_RECRUITING
Hod Hasharon
Local Institution - 0083
NOT_YET_RECRUITING
Jerusalem
Local Institution - 0051
NOT_YET_RECRUITING
Ness Ziona
Local Institution - 0050
NOT_YET_RECRUITING
Ramat Gan
Local Institution - 0090
NOT_YET_RECRUITING
Tirat Carmel
Italy
Local Institution - 0004
NOT_YET_RECRUITING
Ancona
Local Institution - 0002
NOT_YET_RECRUITING
Genova
Local Institution - 0003
NOT_YET_RECRUITING
Milan
Local Institution - 0005
NOT_YET_RECRUITING
Pisa
Local Institution - 0001
NOT_YET_RECRUITING
Siena
Japan
Local Institution - 0139
NOT_YET_RECRUITING
Bunkyo-ku
Local Institution - 0172
NOT_YET_RECRUITING
Kitakata
Local Institution - 0141
NOT_YET_RECRUITING
Kitakyushu-shi
Local Institution - 0142
NOT_YET_RECRUITING
Kochi
Local Institution - 0108
NOT_YET_RECRUITING
Sapporo
Local Institution - 0107
NOT_YET_RECRUITING
Yokohama
Poland
Local Institution - 0103
NOT_YET_RECRUITING
Rybnik
Local Institution - 0082
NOT_YET_RECRUITING
Tuszyn
Romania
Local Institution - 0095
NOT_YET_RECRUITING
Brașov
Local Institution - 0092
NOT_YET_RECRUITING
Bucharest
Local Institution - 0093
NOT_YET_RECRUITING
Bucharest
Local Institution - 0094
NOT_YET_RECRUITING
Bucharest
Local Institution - 0096
NOT_YET_RECRUITING
Bucharest
Local Institution - 0098
NOT_YET_RECRUITING
Bucharest
Local Institution - 0099
NOT_YET_RECRUITING
Bucharest
Local Institution - 0102
NOT_YET_RECRUITING
Bucharest
Local Institution - 0097
NOT_YET_RECRUITING
Iași
Local Institution - 0101
NOT_YET_RECRUITING
Sibiu
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain the NCT# and Site #.
Time Frame
Start Date:2025-10-08
Estimated Completion Date:2027-06-28
Participants
Target number of participants:424
Treatments
Experimental: KarXT + Lithium, Valproate, or Lamotrigine
Placebo_comparator: Placebo + Lithium, Valproate, or Lamotrigine