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A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)

StatusRecruiting
PhasePhase 3
Started2025-06-13
View on ClinicalTrials.gov ↗

Amendment history

2026-09-03
Study Status, Contacts/Locations v22
Study sites85 entries, revised
LocalUniverzitna InstitutionNemocnica -L. 0071Pasteura Kosice
2026-08-17
Study Status, Contacts/Locations v21
Study sites85 entries, revised
LocalKLES InstitutionDr. -Prabhakar 0082Kore Hospital & M.R.C
2026-07-17
Study Status, Contacts/Locations v20
Trial sites expanded: 78 → 85 locations
2026-06-03
Study Status, Contacts/Locations v19
Trial sites expanded: 74 → 78 locations
2026-04-28
Study Status, Contacts/Locations v18
Trial sites expanded: 69 → 74 locations
Show 17 earlier versions
2026-04-06
Study Status, Contacts/Locations v17
Study sites69 entries, revised
LocalSpitalul Institutionde -Psihiatrie 0061și Neurologie Brașov
2026-03-18
Study Status, Contacts/Locations v16
Study sites69 entries, revised
LocalPsihijatrijska Institutionbolnica -"Sveti 0010Ivan" LocalSpitalul InstitutionUniversitar -de 0057Urgenta Militar Central Dr. Carol Davila
2026-03-01
Study Status, Contacts/Locations, IPDSharing v15
Study sites69 entries, revised
LocalPrecise InstitutionResearch -Centers Klinika 0017za psihijatriju "Vrapče" LocalKlinika Institutionza -psihijatriju 0008 Local Institution - 0063"Vrapče"
2026-01-12
Study Status, Contacts/Locations v14
Study sites69 entries, revised
LocalHealth InstitutionSynergy -Clinical 0083Research
2025-12-22
Study Status, Contacts/Locations v13
Study sites69 entries, revised
LocalShalvata InstitutionMental -Health 0042Center LocalKfar InstitutionShaul -Mental 0045Health Center
2025-11-18
Study Status, Eligibility, Contacts/Locations v12
Study sites68→69
Eligibility criteria+33 characters
[...] th depression (for previous 3 months only), BP-II disorder, borderline personality disorder, major depressive disorder, and primary psychotic disorder, w [...]
2025-10-30
Study Status, Contacts/Locations v11
Study sites68 entries, revised
LocalProf. InstitutionDr. -Alexandru 0049Obregia Psychiatry Hospital LocalCentrul Institutionde -Evaluare 0064și Tratament a Toxicodependenței pentru Tineri Sf.Stelian
2025-10-16
Study Status, Contacts/Locations v10
Study sites68 entries, revised
Be'er Sheva Mental Health Center Prof. Dr. Alexandru Obregia Psychiatry Hospital Prof. Dr. Alexandru Obregia Psychiatry Hospital Prof. Dr. Alexandru Obregia Psychiatry Hospital Nacka Local Institution - 0066 Local Institution - 0048 Local Institution - 0060 Local Institution - 0062 Local Institution - 0077Hospital
2025-10-07
Study Status, Contacts/Locations v9
Study sites68 entries, revised
LocalInnovative InstitutionClinical Research, Inc. Hassman Research Institute Marlton Site Prof. Dr. Alexandru Obregia Psychiatry Hospital Prof. Dr. Alexandru Obregia Psychiatry Hospital Osi Bilbao- 0081 Local Institution - 0080 Local Institution - 0050 Local Institution - 0059 Local Institution - 0039Basurto
2025-09-26
Study Status, Contacts/Locations v8
Study sites68 entries, revised
LocalCollaborative InstitutionNeuroscience -Research, 0074LLC LocalSheba InstitutionMedical -Center Hospital 0011 LocalClínic Institutionde - 0044Barcelona
2025-09-08
Study Status, Contacts/Locations v7
Study sites68 entries, revised
LocalLCC InstitutionMedical -Research 0026Institute LocalCBH Institution - 0024Health
2025-08-29
Study Status, Contacts/Locations v6
Study sites66→68
2025-08-11
Study Status, Contacts/Locations v5
Study sites66 entries, revised
LocalClinical InstitutionInnovations, Inc. dba CITrials Behavioral Clinical Research Atlanta Center for Medical Research CenExel iResearch, LLC Neuro-Behavioral 0018 LocalClinical Institution - 0032 Local Institution - 0022 Local Institution - 0016 Local Institution - 0038Research
2025-07-22
Study Status, Contacts/Locations v4
Study sites65→66
2025-06-25
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-06-17→confirmed 2025-06-13
Study sites64→65
2025-05-27
Study Status, Contacts/Locations, References v2
Study sitesdetails revised at 6 of 64 sites
2025-05-02
Study Status, Contacts/Locations v1
Study sites58→64
2025-04-23
Original filing
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.
Trial Details
NCT Number NCT06951711
Lead Sponsor Bristol-Myers Squibb
Conditions Bipolar Disorder Type I With Mania or Mania With Mixed Features
Enrollment 274 participants
Start Date 2025-06-13
Primary Completion 2026-11-02 (estimated)
Study Completion 2026-11-02 (estimated)
Updated on ClinicalTrials.gov 2026-09-24