En undersøgelse til evaluering af effektiviteten og sikkerheden af Karxt til behandling af maniske episoder i Bipolar-I Disorder (Balsam-2)
9. november 2026 opdateret af: Bristol-Myers Squibb
En fase 3, randomiseret, dobbeltblind, placebokontrolleret undersøgelse for at evaluere effektiviteten og sikkerheden af Karxt til behandling af maniske episoder i Bipolar-I Disorder (Balsam-2)
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.
Studieoversigt
Status
Rekruttering
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
274
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: First line of the email MUST contain NCT # and Site #.
Undersøgelse Kontakt Backup
- Navn: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Telefonnummer: 855-907-3286
- E-mail: Clinical.Trials@bms.com
Studiesteder
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Arkansas
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Little Rock, Arkansas, Forenede Stater, 72204
- Rekruttering
- Pillar Clinical Research- Little Rock
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Kontakt:
- Leslie Smith, Site 0014
- Telefonnummer: 501-350-3285
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Rogers, Arkansas, Forenede Stater, 72758
- Rekruttering
- Woodland Research Northwest
-
Kontakt:
- Robert Billingsley, Site 0025
- Telefonnummer: 479-927-3000
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California
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Culver City, California, Forenede Stater, 90230
- Rekruttering
- Proscience Research Group
-
Kontakt:
- Marina Bussel, Site 0021
- Telefonnummer: 424-227-8127
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Riverside, California, Forenede Stater, 92506
- Rekruttering
- Clinical Innovations, Inc. dba CITrials
-
Kontakt:
- Evagelos Coskinas, Site 0018
- Telefonnummer: 951300492
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Torrance, California, Forenede Stater, 90502
- Rekruttering
- Collaborative Neuroscience Research, LLC
-
Kontakt:
- Lara Shirikjian, Site 0074
- Telefonnummer: 310-523-4200
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Florida
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Boynton Beach, Florida, Forenede Stater, 33426
- Rekruttering
- Health Synergy Clinical Research
-
Kontakt:
- Mohammad Nisar, Site 0083
- Telefonnummer: 786-831-7303
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Hialeah Gardens, Florida, Forenede Stater, 33016
- Trukket tilbage
- Local Institution - 0036
-
Hollywood, Florida, Forenede Stater, 33021
- Rekruttering
- Behavioral Clinical Research
-
Kontakt:
- Olga Lapeyra, Site 0032
- Telefonnummer: 954-375-7794
-
Miami, Florida, Forenede Stater, 33126
- Rekruttering
- LCC Medical Research Institute
-
Kontakt:
- Yesenia Kuan, Site 0026
- Telefonnummer: 305-400-0814
-
Miami Lakes, Florida, Forenede Stater, 33016
- Rekruttering
- Innovative Clinical Research, Inc.
-
Kontakt:
- Rishi Kakar, Site 0081
- Telefonnummer: 786-512-4106
-
Miami Springs, Florida, Forenede Stater, 33166
- Rekruttering
- South Florida Research Phase I-IV
-
Kontakt:
- Silvia Silva Duluc, Site 0015
- Telefonnummer: 305-669-6166
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Tampa, Florida, Forenede Stater, 33618
- Trukket tilbage
- Local Institution - 0019
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Georgia
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Atlanta, Georgia, Forenede Stater, 30331
- Rekruttering
- Atlanta Center for Medical Research
-
Kontakt:
- Elyssa Barron, Site 0022
- Telefonnummer: 404-881-5800
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Decatur, Georgia, Forenede Stater, 30030
- Rekruttering
- CenExel iResearch, LLC
-
Kontakt:
- Kimball Johnson, Site 0016
- Telefonnummer: 404-537-1281
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Illinois
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Chicago, Illinois, Forenede Stater, 60640
- Ikke rekrutterer endnu
- Local Institution - 0020
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Kontakt:
- Site 0020
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Maryland
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Gaithersburg, Maryland, Forenede Stater, 20877
- Rekruttering
- CBH Health
-
Kontakt:
- Elia Acevedo Diaz, Site 0024
- Telefonnummer: 301-251-4702
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Mississippi
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Flowood, Mississippi, Forenede Stater, 39232
- Rekruttering
- Precise Research Centers
-
Kontakt:
- Joseph Kwentus, Site 0017
- Telefonnummer: 601-420-5810
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Missouri
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St Louis, Missouri, Forenede Stater, 63141
- Rekruttering
- Arch Clinical Trials
-
Kontakt:
- Junaid Syed, Site 0023
- Telefonnummer: 314-771-6387
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Nevada
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North Las Vegas, Nevada, Forenede Stater, 89030
- Trukket tilbage
- Local Institution - 0076
-
-
New Jersey
-
Marlton, New Jersey, Forenede Stater, 08053
- Rekruttering
- Hassman Research Institute Marlton Site
-
Kontakt:
- Elan Cohen, Site 0080
- Telefonnummer: 267-981-8911
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Marlton, New Jersey, Forenede Stater, 08053
- Trukket tilbage
- Local Institution - 0031
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North Carolina
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Charlotte, North Carolina, Forenede Stater, 28211
- Trukket tilbage
- Local Institution - 0075
-
-
Ohio
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Cincinnati, Ohio, Forenede Stater, 45219
- Rekruttering
- University of Cincinnati Medical Center
-
Kontakt:
- Caleb Adler, Site 0029
- Telefonnummer: 513-404-0279
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North Canton, Ohio, Forenede Stater, 44720
- Rekruttering
- Neuro-Behavioral Clinical Research
-
Kontakt:
- Shishuka Malhotra, Site 0038
- Telefonnummer: 330-493-1118
-
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Texas
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DeSoto, Texas, Forenede Stater, 75115
- Rekruttering
- Adams Clinical Dallas
-
Kontakt:
- Rajinder Shiwach, Site 0012
- Telefonnummer: 972-283-6286
-
Houston, Texas, Forenede Stater, 77021
- Trukket tilbage
- Local Institution - 0028
-
Richardson, Texas, Forenede Stater, 75080
- Rekruttering
- Pillar Clinical Research
-
Kontakt:
- Fayz Hudefi, Site 0095
- Telefonnummer: 479-367-2688
-
Richardson, Texas, Forenede Stater, 75080
- Rekruttering
- Pillar Clinical Research - Richardson
-
Kontakt:
- Scott Bartley, Site 0037
- Telefonnummer: 214-396-4844
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-
-
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Andhra Pradesh
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Visakhapatnam, Andhra Pradesh, Indien, 530048
- Ikke rekrutterer endnu
- Local Institution - 0099
-
Kontakt:
- Site 0099
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Gujarat
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Vadodara, Gujarat, Indien, 390021
- Rekruttering
- GMERS Medical College and General Hospital
-
Kontakt:
- Sandip Shah, Site 0065
- Telefonnummer: 9824060683
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Karnataka
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Belagavi, Karnataka, Indien, 590010
- Rekruttering
- KLES Dr. Prabhakar Kore Hospital & M.R.C
-
Kontakt:
- Bheemsain Tekkalaki, Site 0082
- Telefonnummer: +91-0831-2444040
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Kerala
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Kozhikode, Kerala, Indien, 673009
- Rekruttering
- Chethana Center for Neuropsychiatry
-
Kontakt:
- SURESHKUMAR N, Site 0053
- Telefonnummer: 9447218825
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Punjab
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Ludhiana, Punjab, Indien, 141001
- Rekruttering
- Dayanand Medical College and Hospital
-
Kontakt:
- Navkiran Mahajan, Site 0051
- Telefonnummer: 9872655008
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Tamil Nadu
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Madurai, Tamil Nadu, Indien, 625020
- Ikke rekrutterer endnu
- Local Institution - 0098
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Kontakt:
- Site 0098
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Telangana
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Hyderabad, Telangana, Indien, 500082
- Ikke rekrutterer endnu
- Local Institution - 0055
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Kontakt:
- Site 0055
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Hyderabad, Telangana, Indien, 500034
- Rekruttering
- Asha Hospital - Hyderabad
-
Kontakt:
- G Rao, Site 0052
- Telefonnummer: 9985900005
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West Bengal
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Kolkata, West Bengal, Indien, 700014
- Rekruttering
- Nil Ratan Sircar Medical College and Hospital
-
Kontakt:
- Asish Mukhopadhyay, Site 0054
- Telefonnummer: 8250737511
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-
-
-
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Jerusalem, Israel, 9546105
- Rekruttering
- Kfar Shaul Mental Health Center
-
Kontakt:
- Alexander Teitelbaum, Site 0045
- Telefonnummer: +972-506262005
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Central District
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Hod HaSharon, Central District, Israel, 4534708
- Rekruttering
- Shalvata Mental Health Center
-
Kontakt:
- Yuri Fonar, Site 0042
- Telefonnummer: +972545838725
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Ness Ziona, Central District, Israel, 7410001
- Rekruttering
- Ness Ziona Mental Health Center
-
Kontakt:
- Marina Kupchik, Site 0046
- Telefonnummer: +972506261093
-
Petah Tikva, Central District, Israel, 4910002
- Ikke rekrutterer endnu
- Local Institution - 0058
-
Kontakt:
- Site 0058
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Ramat Gan, Central District, Israel, 5265601
- Rekruttering
- Sheba Medical Center
-
Kontakt:
- Linda Levi-Haramati, Site 0011
- Telefonnummer: 0585950299
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Southern District
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Beersheba, Southern District, Israel, 8461144
- Rekruttering
- Be'er Sheva Mental Health Center
-
Kontakt:
- Yuly Bersudsky, Site 0066
- Telefonnummer: 972-8-6401463
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-
-
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Ancona, Italien, 60126
- Trukket tilbage
- Local Institution - 0041
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Genova, Italien, 16132
- Trukket tilbage
- Local Institution - 0040
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Lombardy
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Milan, Lombardy, Italien, 20122
- Trukket tilbage
- Local Institution - 0001
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Tuscany
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Pisa, Tuscany, Italien, 56126
- Trukket tilbage
- Local Institution - 0056
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Siena, Tuscany, Italien, 53100
- Trukket tilbage
- Local Institution - 0007
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100088
- Ikke rekrutterer endnu
- Local Institution - 0106
-
Kontakt:
- Site 0106
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Beijing, Beijing Municipality, Kina, 100088
- Rekruttering
- Beijing Anding Hospital - Affiliated Capital University of Medical Science
-
Kontakt:
- Xiaoning Shi, Site 0103
- Telefonnummer: 8613691412420
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Hubei
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Wuhan, Hubei, Kina, 430012
- Ikke rekrutterer endnu
- Local Institution - 0108
-
Kontakt:
- Site 0108
-
-
Hunan
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Changsha, Hunan, Kina, 410007
- Ikke rekrutterer endnu
- Local Institution - 0107
-
Kontakt:
- Site 0107
-
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Shandong
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Jining Shi, Shandong, Kina, 272051
- Ikke rekrutterer endnu
- Local Institution - 0105
-
Kontakt:
- Site 0105
-
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Tianjin Municipality
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Tianjin, Tianjin Municipality, Kina, 300022
- Ikke rekrutterer endnu
- Local Institution - 0104
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Kontakt:
- Site 0104
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-
-
-
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Zagreb, Kroatien, 10090
- Rekruttering
- Klinika za psihijatriju "Vrapče"
-
Kontakt:
- Miroslav Herceg, Site 0008
- Telefonnummer: 3853780732
-
Kontakt:
- Ninoslav Mimica, Site 0063
- Telefonnummer: +38513780678
-
Kontakt:
- Marko Curkovic, Site 0078
- Telefonnummer: 385951648446
-
Zagreb, Kroatien, 10090
- Rekruttering
- Psihijatrijska bolnica "Sveti Ivan"
-
Kontakt:
- Igor Filipcic, Site 0010
- Telefonnummer: 38513430020
-
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City of Zagreb
-
Zagreb, City of Zagreb, Kroatien, 10090
- Trukket tilbage
- Local Institution - 0009
-
-
-
-
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Bucharest, Rumænien, 060222
- Rekruttering
- Centrul de Evaluare și Tratament a Toxicodependenței pentru Tineri Sf.Stelian
-
Kontakt:
- Traian Barbu, Site 0064
- Telefonnummer: +40723652564
-
Bucharest, Rumænien
- Rekruttering
- Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila
-
Kontakt:
- Octavian Vasiliu, Site 0057
- Telefonnummer: 0040723725815
-
Iași, Rumænien, 700282
- Trukket tilbage
- Local Institution - 0047
-
Sanpetru /Brasov, Rumænien, 507190
- Rekruttering
- Spitalul de Psihiatrie și Neurologie Brașov
-
Kontakt:
- Petru Ifteni, Site 0061
- Telefonnummer: 0040724993329
-
-
Bucharest
-
Bucharest, Bucharest, Rumænien, 041914
- Rekruttering
- Prof. Dr. Alexandru Obregia Psychiatry Hospital
-
Kontakt:
- Corina Nicolae, Site 0059
- Telefonnummer: +40727818190
-
Kontakt:
- ADELA CIOBANU, Site 0050
- Telefonnummer: 0040723671301
-
Kontakt:
- Valentin Matei, Site 0048
- Telefonnummer: +40721243869
-
Kontakt:
- Mihnea Manea, Site 0060
- Telefonnummer: 0040745974029
-
Kontakt:
- Laura Cristina Dolis, Site 0062
- Telefonnummer: 0040757243543
-
Kontakt:
- SIMONA TRIFU, Site 0049
- Telefonnummer: 0040731581100
-
Bucharest, Bucharest, Rumænien, 11241
- Rekruttering
- Institutul National de Gerontologie si Geriatrie "Ana Aslan" - Clinica Bucuresti
-
Kontakt:
- Traian Purnichi, Site 0097
- Telefonnummer: +40749156565
-
-
-
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Košice Region
-
Košice, Košice Region, Slovakiet, 040 01
- Rekruttering
- EPAMED - Košice - Hlavná
-
Kontakt:
- Eva Palova, Site 0073
- Telefonnummer: 00421902539617
-
Košice, Košice Region, Slovakiet, 040 01
- Rekruttering
- Univerzitna Nemocnica L. Pasteura Kosice
-
Kontakt:
- Slavka Dubinska, Site 0071
- Telefonnummer: +421903625643
-
-
Presov
-
Vranov nad Topľou, Presov, Slovakiet, 093 01
- Rekruttering
- Crystal Comfort
-
Kontakt:
- Dagmar Breznoscakova, Site 0072
-
-
-
-
Barcelona [Barcelona]
-
Barcelona, Barcelona [Barcelona], Spanien, 08035
- Afsluttet
- Local Institution - 0069
-
-
Basque Country
-
Bilbao, Basque Country, Spanien, 48013
- Afsluttet
- Local Institution - 0039
-
-
Catalunya [Cataluña]
-
Barcelona, Catalunya [Cataluña], Spanien, 08036
- Afsluttet
- Local Institution - 0044
-
-
-
-
Stockholms Län [se-01]
-
Nacka, Stockholms Län [se-01], Sverige, 131 45
- Afsluttet
- Local Institution - 0077
-
-
Uppsala Län [se-03]
-
Uppsala, Uppsala Län [se-03], Sverige, 751 85
- Trukket tilbage
- Local Institution - 0067
-
-
Västra Götalands Län [se-14]
-
Gothenburg, Västra Götalands Län [se-14], Sverige, 413 45
- Trukket tilbage
- Local Institution - 0070
-
-
-
-
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Odesa, Ukraine, 65006
- Rekruttering
- Municipal Non-Commercial Enterprise "Odesa Regional Medical Centre of Mental Health" of Odesa Regional Council
-
Kontakt:
- Anatolii Voloshchuk, Site 0094
- Telefonnummer: 38 0637356555
-
Poltava, Ukraine, 36013
- Rekruttering
- Communal Enterprise "Regional Institution of Mental Psychiatric Care of the Poltava Regional Council"
-
Kontakt:
- Andriy Skrypnikov, Site 0090
- Telefonnummer: +380502523300
-
-
Dnipropetrovsk Oblast
-
Dnipro, Dnipropetrovsk Oblast, Ukraine, 49115
- Rekruttering
- MUNICIPAL NON-COMMERCIAL COMPANY Dnipropetrovsk Multiprofile Clinical Hospital for Provision of Psychiatric Care DRC
-
Kontakt:
- Svitlana Moroz, Site 0088
- Telefonnummer: +380675658914
-
-
Kirovohrad Oblast
-
Kropyvnytskyi, Kirovohrad Oblast, Ukraine, 25491
- Rekruttering
- Communal Non-Commercial Enterprise "Regional Clinical Psychiatric Hospital of the Kirovohrad Regional Council
-
Kontakt:
- Yevhen Denysov, Site 0084
- Telefonnummer: +380505641035
-
-
Kyiv Oblast
-
Hlevakha, Kyiv Oblast, Ukraine, 08631
- Rekruttering
- Communal non-commercial enterprise of the Kyiv Regional Council "Regional Psychiatric-Narcological Medical Association"
-
Kontakt:
- Gennadii Zilberblat, Site 0092
- Telefonnummer: 380506480750
-
-
Odesa Oblast
-
Oleksandrivka, Odesa Oblast, Ukraine, 67513
- Rekruttering
- Municipal Non-Commercial Enterprise "Odesa Regional Medical Centre of Mental Health" of Odesa Regional Council
-
Kontakt:
- Yevgen Oprya, Site 0093
- Telefonnummer: +380679920420
-
-
Vinnytsia Oblast
-
Vinnytsia, Vinnytsia Oblast, Ukraine, 21037
- Rekruttering
- Communal non-profit enterprise "Vinnytsia Regional Clinical Psycho-Neurological Hospital n.a. acad. O.I. Yushchenko of VRC"
-
Kontakt:
- Oksana Serebrennikova, Site 0085
- Telefonnummer: +380679605672
-
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 65 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
|
Specified dose on specified days |
|
Eksperimentel: KarXT
Flexible dosing |
Specified dose on specified days
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline in Young Mania Rating Scale (YMRS) score
Tidsramme: At week 3
|
The YMRS comprised of 11 items that assess the severity of manic symptoms. All items are given a severity rating, with 4 items graded from 0 to 8 (irritability, speech, thought content, and disruptive/aggressive behavior), and the remaining 7 items are graded from 0 to 4 points. The highest score obtainable on the YMRS is 60 and the higher the number the greater the number of symptoms and/or the greater their severity. |
At week 3
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Forekomst af respons baseret på ≥ 50% fald fra baseline i YMRS -score eller total score
Tidsramme: I uge 3
|
I uge 3
|
|
|
Forekomst af respons baseret på ændring fra baseline ≥ 1 i CGI-BP
Tidsramme: I uge 3
|
I uge 3
|
|
|
Change from baseline in Clinical Global Impressions-Bipolar (CGI-BP)
Tidsramme: At week 3
|
The CGI-BP is designed to assess the severity, improvement, and efficacy of treatment in individuals with bipolar disorder. Only section I, illness severity, will be used, which includes three components: mania, depression, and overall bipolar illness. The ratings are on a 7-point scale (1 = normal, not ill; 2 = minimally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = very severely ill). |
At week 3
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Bristol-Myers Squibb, Bristol-Myers Squibb
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
13. juni 2025
Primær færdiggørelse (Anslået)
2. november 2026
Studieafslutning (Anslået)
2. november 2026
Datoer for studieregistrering
Først indsendt
23. april 2025
Først indsendt, der opfyldte QC-kriterier
23. april 2025
Først opslået (Faktiske)
30. april 2025
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. november 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. november 2026
Sidst verificeret
1. november 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CN012-0037
- 2024-520195-94 (Anden identifikator: EU CTR)
- U1111-1316-7466 (Anden identifikator: WHO)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
IPD-delingstidsramme
See Plan Description
IPD-delingsadgangskriterier
See Plan Description
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .