Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06951698 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

Study acronym: BALSAM-1
StatusRecruiting
PhasePhase 3
Started2025-06-11
View on ClinicalTrials.gov ↗

Amendment history

2026-09-03
Study Status, Contacts/Locations v15
Study sites73→74
2026-07-24
Study Status, Contacts/Locations v14
Trial sites expanded: 69 → 73 locations
2026-06-25
Study Status, Contacts/Locations v13
Trial sites expanded: 63 → 69 locations
2026-04-13
Study Status, Contacts/Locations v12
Study sites63 entries, revised
LocalCentrum InstitutionMedyczne -HCP Instytut 0095Psychiatrii i Neurologii LocalKlinika InstitutionPsychiatrii -Uniwersytet 0107Medyczny w Białymstoku LocalM2M Institution - 0094 Local Institution - 0103Med
2026-03-16
Study Status, Contacts/Locations v11
Study sites63 entries, revised
LocalConnecticut InstitutionMental -Health 0124Center LocalHospital InstitutionItaliano -de 0110Buenos Aires LocalState InstitutionPsychiatric -Hospital 0119Sv. Ivan Rilski Novi Iskar LocalNorth InstitutionShore -Hospital Clinica 0055 Local Institution - 0096Inventiva
Show 10 earlier versions
2026-02-20
Study Status, Contacts/Locations, IPDSharing v10
Study sites63 entries, revised
LocalSanatorio InstitutionMorra S.A. "University Multiprofile Hospital for Active Treatment - 0115Dr. Georgi Stranski" EAD LocalMHAT Institution"Dr. Ival Seliminski" Mental Health Center - 0112Vratsa LocalHotei InstitutionHospital Miyazaki -Prefectural 0120 LocalMiyazaki Institution - 0121 Local Institution - 0082 Local Institution - 0077Hospital
2025-12-16
Study Status, Contacts/Locations v9
Study sites63 entries, revised
LocalPetz InstitutionAladar -Egyetemi 0116Oktato Korhaz LocalSemmelweis InstitutionEgyetem Kansai -Medical 0118 LocalUniversity InstitutionMedical - 0089Center
2025-12-03
Study Identification, Study Status, Outcome Measures, Eligibility, Contacts/Locations v8
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 [...]
Secondary endpoints3 entries, revised
Occurrence of response based on a ≥ 50% decrease from baseline in YMRS total score
Study sites63 entries, revised
LocalCenExel InstitutioniResearch, -LLC Center 0057for Mental Health Prof. Dr. Ivan Temkov LocalWakayama InstitutionMedical -University 0113Hospital LocalYamagata InstitutionSakuracho - 0076 Local Institution - 0088Hospital
2025-10-17
Study Status, Contacts/Locations v7
Study sites63 entries, revised
LocalCollaborative InstitutionNeuroscience Research, LLC Catalina Research Institute, LLC Okehazama Hospital Goryokai Medical Corporation - 0059Goryokai Hospital LocalNational InstitutionCenter -of 0072Neurology and Psychiatry LocalOsaka InstitutionMetropolitan -University 0079 Local Institution - 0080 Local Institution - 0105 Local Institution - 0086Hospital
2025-09-22
Study Status, Contacts/Locations v6
Study sites63 entries, revised
LocalNational InstitutionKohnodai -Medical 0078Center.
2025-09-11
Study Status, Contacts/Locations v5
Study sites62→63
2025-08-19
Study Status, Contacts/Locations v4
Study sites62 entries, revised
LocalAdvanced InstitutionResearch -Center 0005Inc. LocalCITrials Richmond InstitutionBehavioral -Associates Ramsay 0008Clinic Northside LocalSaitama InstitutionKonan -Hospital Kuramitsu 0030 Local Institution - 0117 Local Institution - 0092 Local Institution - 0083Hospital
2025-07-29
Study Status, Contacts/Locations v3
Study sites62 entries, revised
LocalPillar InstitutionClinical Research - 0058Richardson LocalInnovative InstitutionClinical Research, Inc. Pillar Clinical Research -Chicago Neuro-Behavioral 0054Clinical Research LocalShowa InstitutionMedical -University 0047 LocalKarasuyama Institution - 0013 Local Institution - 0104Hospital
2025-07-14
Study Status, Contacts/Locations v2
Study sites61→62
2025-06-16
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations, References v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-06-17→confirmed 2025-06-11
Study sites61 entries, revised
LocalHealth InstitutionSynergy Clinical Research Pillar Clinical Research - 0023 Local Institution - 0044Richardson
2025-04-23
Original filing
The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder
Trial Details
NCT Number NCT06951698
Lead Sponsor Bristol-Myers Squibb
Conditions Bipolar-I Disorder With Mania or Mania With Mixed Features
Enrollment 274 participants
Start Date 2025-06-11
Primary Completion 2026-11-01 (estimated)
Study Completion 2026-11-01 (estimated)
Updated on ClinicalTrials.gov 2026-09-22