En studie for å evaluere effektiviteten og sikkerheten til Karxt for behandling av maniske episoder i bipolar-i-lidelse (BALSAM-1)
22. oktober 2026 oppdatert av: Bristol-Myers Squibb
En fase 3, randomisert, dobbeltblind, placebokontrollert studie for å evaluere effektiviteten og sikkerheten til Karxt for behandling av maniske episoder i Bipolar-I Disorder (Balsam-1)
The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Detaljert beskrivelse
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in subjects 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.
Studietype
Intervensjonell
Registrering (Antatt)
274
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: First line of the email MUST contain NCT # and Site #.
Studer Kontakt Backup
- Navn: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- Telefonnummer: 855-907-3286
- E-post: Clinical.Trials@bms.com
Studiesteder
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-
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Córdoba, Argentina, 5000
- Rekruttering
- Sanatorio Morra S.A.
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Ta kontakt med:
- Carlos Morra, Site 0115
- Telefonnummer: 5493516858696
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Mendoza, Argentina, 5502
- Har ikke rekruttert ennå
- Local Institution - 0109
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Ta kontakt med:
- Site 0109
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Santiago del Estero, Argentina, G4200DND
- Har ikke rekruttert ennå
- Local Institution - 0140
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Ta kontakt med:
- Site 0140
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Buenos Aires F.D.
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ABB, Buenos Aires F.D., Argentina, C1199ABB
- Rekruttering
- Hospital Italiano de Buenos Aires
-
Ta kontakt med:
- José Faccioli, Site 0110
- Telefonnummer: +5491157934078
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Mendoza Province
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Las Heras, Mendoza Province, Argentina, 5539
- Rekruttering
- Clinica del Prado
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Ta kontakt med:
- Eugenio Velasco, Site 0108
- Telefonnummer: 54-261-9-155861633
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-
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New South Wales
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St Leonards, New South Wales, Australia, 2065
- Rekruttering
- Ramsay Clinic Northside
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Ta kontakt med:
- Philip Mitchell, Site 0117
- Telefonnummer: +61 2 9433 3555
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Queensland
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Brisbane, Queensland, Australia, 4005
- Rekruttering
- Ramsay Clinic New Farm
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Ta kontakt med:
- James Scott, Site 0106
- Telefonnummer: +61 7 3069 7398
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-
-
-
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Burgas, Bulgaria, 8001
- Rekruttering
- Center for Mental Health Prof. Dr. Ivan Temkov
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Ta kontakt med:
- Veselin Palazov, Site 0113
- Telefonnummer: 359888451225
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Haskovo, Bulgaria, 6300
- Har ikke rekruttert ennå
- Local Institution - 0139
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Ta kontakt med:
- Site 0139
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Novi Iskar, Bulgaria, 1282
- Rekruttering
- State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar
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Ta kontakt med:
- Tsveteslava Galabova, Site 0119
- Telefonnummer: 359892444643
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Pleven, Bulgaria, 5800
- Rekruttering
- "University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD
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Ta kontakt med:
- Maya Stoimenova - Popova, Site 0112
- Telefonnummer: +359888227165
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Sliven, Bulgaria, 8800
- Rekruttering
- MHAT "Dr. Ival Seliminski"
-
Ta kontakt med:
- Rozalina Petrova, Site 0120
- Telefonnummer: 00359887801545
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Vratsa, Bulgaria, 3000
- Rekruttering
- Mental Health Center - Vratsa
-
Ta kontakt med:
- Nadya Ivanova, Site 0121
- Telefonnummer: +359887422440
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Stara Zagora
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Kazanlak, Stara Zagora, Bulgaria, 6100
- Har ikke rekruttert ennå
- Local Institution - 0138
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Ta kontakt med:
- Site 0138
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Arkansas
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Bentonville, Arkansas, Forente stater, 72712
- Aktiv, ikke rekrutterende
- Local Institution - 0058
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Little Rock, Arkansas, Forente stater, 72211
- Rekruttering
- Woodland International Research Group
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Ta kontakt med:
- George Konis, Site 0011
- Telefonnummer: 501-221-8681
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California
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Anaheim, California, Forente stater, 92805
- Rekruttering
- Advanced Research Center Inc.
-
Ta kontakt med:
- Steven Macina, Site 0005
- Telefonnummer: 714-999-6688
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Bellflower, California, Forente stater, 90706
- Rekruttering
- CITrials
-
Ta kontakt med:
- Gerald Maguire, Site 0008
- Telefonnummer: 562-249-6956
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Cerritos, California, Forente stater, 90703
- Har ikke rekruttert ennå
- Local Institution - 0014
-
Ta kontakt med:
- Site 0014
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Long Beach, California, Forente stater, 90806
- Rekruttering
- Collaborative Neuroscience Research, LLC
-
Ta kontakt med:
- David Walling, Site 0059
- Telefonnummer: 714-799-7799
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Los Angeles, California, Forente stater, 90015
- Rekruttering
- NRC Research Institute
-
Ta kontakt med:
- Tony Ortiz, Site 0053
- Telefonnummer: 714-289-1100
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Montclair, California, Forente stater, 91763
- Rekruttering
- Catalina Research Institute, LLC
-
Ta kontakt med:
- Stephen Volk, Site 0072
- Telefonnummer: 909-590-8409
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Connecticut
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New Haven, Connecticut, Forente stater, 06519
- Rekruttering
- Connecticut Mental Health Center
-
Ta kontakt med:
- Deepak D'Souza, Site 0124
- Telefonnummer: 20393257112594
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Florida
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Hollywood, Florida, Forente stater, 33024
- Rekruttering
- Research Centers of America ( Hollywood )
-
Ta kontakt med:
- Edwin Gomez, Site 0043
- Telefonnummer: 954-604-3900
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Homestead, Florida, Forente stater, 33033
- Rekruttering
- Advanced Research Institute of Miami
-
Ta kontakt med:
- Moraima Trujillo, Site 0020
- Telefonnummer: 305-246-0001
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Miami, Florida, Forente stater, 33166
- Rekruttering
- South Florida Research Phase I-IV
-
Ta kontakt med:
- Silvia Silva Duluc, Site 0069
- Telefonnummer: 305-669-6166
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Miami Lakes, Florida, Forente stater, 33016
- Rekruttering
- Innovative Clinical Research, Inc.
-
Ta kontakt med:
- Rishi Kakar, Site 0054
- Telefonnummer: 786-512-4106
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Miami Lakes, Florida, Forente stater, 33016
- Har ikke rekruttert ennå
- Local Institution - 0015
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Ta kontakt med:
- Site 0015
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West Palm Beach, Florida, Forente stater, 33407
- Rekruttering
- Health Synergy Clinical Research
-
Ta kontakt med:
- Mohammad Nisar, Site 0023
- Telefonnummer: 786-831-7303
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Georgia
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Atlanta, Georgia, Forente stater, 30328
- Rekruttering
- Synexus Clinical Research US, Inc.
-
Ta kontakt med:
- Bethany Davis, Site 0009
- Telefonnummer: 404-255-6005
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Savannah, Georgia, Forente stater, 31405
- Rekruttering
- CenExel iResearch, LLC
-
Ta kontakt med:
- Michael Mobley, Site 0057
- Telefonnummer: 912-744-0800
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Illinois
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Chicago, Illinois, Forente stater, 60641
- Rekruttering
- Pillar Clinical Research -Chicago
-
Ta kontakt med:
- Roueen Rafeyan, Site 0047
- Telefonnummer: 312-865-6336
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New York
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Staten Island, New York, Forente stater, 10314
- Rekruttering
- Richmond Behavioral Associates
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Ta kontakt med:
- Peter Weiden, Site 0030
- Telefonnummer: 917-701-7484
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Ohio
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North Canton, Ohio, Forente stater, 44720
- Rekruttering
- Neuro-Behavioral Clinical Research
-
Ta kontakt med:
- Shishuka Malhotra, Site 0013
- Telefonnummer: 330-493-1118
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Texas
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Austin, Texas, Forente stater, 78754
- Rekruttering
- Community Clinical Research
-
Ta kontakt med:
- David Brown, Site 0141
- Telefonnummer: 512-323-2622
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Irving, Texas, Forente stater, 75062
- Tilbaketrukket
- Local Institution - 0029
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Richardson, Texas, Forente stater, 75080
- Rekruttering
- Pillar Clinical Research - Richardson
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Ta kontakt med:
- Scott Bartley, Site 0044
- Telefonnummer: 214-396-4844
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Fukuoka, Japan, 819-0037
- Rekruttering
- Kuramitsu Hospital
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Ta kontakt med:
- Noriko Tamaru, Site 0083
- Telefonnummer: +81-92-811-1821
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Miyazaki, Japan, 880-8510
- Rekruttering
- Miyazaki Prefectural Miyazaki Hospital
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Ta kontakt med:
- Jiro Kawano, Site 0077
- Telefonnummer: 81985244181
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Osaka, Japan, 590-0018
- Tilbaketrukket
- Local Institution - 0084
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Osaka, Japan, 545-8586
- Rekruttering
- Osaka Metropolitan University Hospital
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Ta kontakt med:
- Yasuhiko Deguchi, Site 0086
- Telefonnummer: +81-6-6645-3821
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Tokyo, Japan, 157-8577
- Rekruttering
- Showa Medical University Karasuyama Hospital
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Ta kontakt med:
- Kenji Sanada, Site 0104
- Telefonnummer: +81-3-3300-5231
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Wakayama, Japan, 641-8510
- Rekruttering
- Wakayama Medical University Hospital
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Ta kontakt med:
- Sohei Kimoto, Site 0076
- Telefonnummer: 073-441-0659
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Yamagata, Japan, 990-0045
- Rekruttering
- Yamagata Sakuracho Hospital
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Ta kontakt med:
- Nobuhiro Yokokawa, Site 0088
- Telefonnummer: +81236312315
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Aichi-ken
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Kōnan, Aichi-ken, Japan, 4838248
- Fullført
- Local Institution - 0082
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Toyoake, Aichi-ken, Japan, 470-1168
- Rekruttering
- Okehazama Hospital
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Ta kontakt med:
- kiyoshi Fujita, Site 0079
- Telefonnummer: 0562971361
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Chiba
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Ichikawa, Chiba, Japan, 272-8516
- Rekruttering
- National Kohnodai Medical Center.
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Ta kontakt med:
- Toshihiko Ito, Site 0078
- Telefonnummer: +81-47-372-3501
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Fukuoka
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Kitakyushu, Fukuoka, Japan, 803-0831
- Tilbaketrukket
- Local Institution - 0100
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Hokkaido
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Obihiro, Hokkaido, Japan, 080-0024
- Rekruttering
- Obihiro Kosei Hospital
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Ta kontakt med:
- Kengo Furuse, Site 0090
- Telefonnummer: 81155650102
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Sapporo, Hokkaido, Japan, 002-8029
- Rekruttering
- Goryokai Medical Corporation - Goryokai Hospital
-
Ta kontakt med:
- Kimihiro Nakajima, Site 0080
- Telefonnummer: +81-11-771-5660
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Osaka
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Moriguchi, Osaka, Japan, 570-8507
- Rekruttering
- Kansai Medical University Medical Center
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Ta kontakt med:
- Masaki Kato, Site 0089
- Telefonnummer: +81-6-6992-1001
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Saga-ken
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Karatsu-shi, Saga-ken, Japan, 847-0031
- Rekruttering
- Rainbow and Sea Hospital
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Ta kontakt med:
- Taro Shindo, Site 0087
- Telefonnummer: 0955770711
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Saitama
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Iruma, Saitama, Japan, 350-0495
- Tilbaketrukket
- Local Institution - 0081
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Kumagaya, Saitama, Japan, 360-0114
- Rekruttering
- Saitama Konan Hospital
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Ta kontakt med:
- Narifumi Yokoyama, Site 0092
- Telefonnummer: 048-536-1366
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Tokyo
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Kodaira, Tokyo, Japan, 187-8551
- Rekruttering
- National Center of Neurology and Psychiatry
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Ta kontakt med:
- Takamasa Noda, Site 0105
- Telefonnummer: +81-42-341-2711
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tabashi City, Tokyo, Japan, 175-0091
- Rekruttering
- Narimasu Kosei Hospital
-
Ta kontakt med:
- Yuya Tenjin, Site 0085
- Telefonnummer: 0339391191
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-
-
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Auckland, New Zealand, 0622
- Rekruttering
- North Shore Hospital
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Ta kontakt med:
- Sylvester Miles, Site 0055
- Telefonnummer: +6421963555
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-
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Tuszyn, Polen, 95-080
- Rekruttering
- Clinica Inventiva
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Ta kontakt med:
- Jaroslaw Strzelec, Site 0096
- Telefonnummer: 602305132
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Greater Poland Voivodeship
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Poznan, Greater Poland Voivodeship, Polen, 61-485
- Rekruttering
- Centrum Medyczne HCP
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Ta kontakt med:
- Sylwia Szymkowiak, Site 0095
- Telefonnummer: +48604116632
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polen, 02-957
- Rekruttering
- Instytut Psychiatrii i Neurologii
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Ta kontakt med:
- Adam Wichniak, Site 0107
- Telefonnummer: +48600-107-410
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Podlaskie Voivodeship
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Bialystok, Podlaskie Voivodeship, Polen, 15-272
- Rekruttering
- Klinika Psychiatrii Uniwersytet Medyczny w Białymstoku
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Ta kontakt med:
- Napoleon Waszkiewicz, Site 0094
- Telefonnummer: +48608888796
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Pomeranian Voivodeship
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Gdansk, Pomeranian Voivodeship, Polen, 80-214
- Har ikke rekruttert ennå
- Local Institution - 0111
-
Ta kontakt med:
- Site 0111
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Silesian Voivodeship
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Rybnik, Silesian Voivodeship, Polen, 44-200
- Rekruttering
- M2M Med
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Ta kontakt med:
- Wojciech Eysymontt, Site 0103
- Telefonnummer: +48609673001
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Sosnowiec, Silesian Voivodeship, Polen, 41-200
- Har ikke rekruttert ennå
- Local Institution - 0102
-
Ta kontakt med:
- Site 0102
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-
-
-
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Kyiv, Ukraina, 04080
- Rekruttering
- CNCE "Clinical Facility for Mental Health Care "PSYCHIATRY" of executive body of Kyiv City Council (KCSA)
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Ta kontakt med:
- Yuliya Blazhevych, Site 0129
- Telefonnummer: +380503847048
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Poltava, Ukraina, 36013
- Rekruttering
- Communal Enterprise "Regional Institution of Mental Psychiatric Care of the Poltava Regional Council"
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Ta kontakt med:
- Andriy Skrypnikov, Site 0132
- Telefonnummer: +380502523300
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Smila, Ukraina, 20708
- Rekruttering
- Communal non-commercial enterprise "Cherkasy regional psychiatric hospital of Cherkasy regional council"
-
Ta kontakt med:
- Iryna Kosenkova, Site 0131
- Telefonnummer: 380473321979
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Ternopil, Ukraina, 46027
- Har ikke rekruttert ennå
- Local Institution - 0137
-
Ta kontakt med:
- Site 0137
-
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Dnipropetrovsk Oblast
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Dnipro, Dnipropetrovsk Oblast, Ukraina, 49115
- Rekruttering
- MUNICIPAL NON-COMMERCIAL COMPANY Dnipropetrovsk Multiprofile Clinical Hospital for Provision of Psychiatric Care DRC
-
Ta kontakt med:
- Svitlana Moroz, Site 0130
- Telefonnummer: +380675658914
-
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Khmelnytskyi Oblast
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Skarzhyntsi, Khmelnytskyi Oblast, Ukraina, 32120
- Rekruttering
- Municipal Non-Commercial Enterprise "Khmelnytskyi Regional Psychiatric Care Facility" of the Khmelnytskyi Regional Council
-
Ta kontakt med:
- Viktoriia Kachynska, Site 0133
- Telefonnummer: 380672624158
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Kirovohrad Oblast
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Kropyvnytskyi, Kirovohrad Oblast, Ukraina, 25491
- Rekruttering
- Communal Non-Commercial Enterprise "Regional Clinical Psychiatric Hospital of the Kirovohrad Regional Council
-
Ta kontakt med:
- Yevhen Denysov, Site 0126
- Telefonnummer: +380505641035
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-
-
-
-
Budapest, Ungarn, 1083
- Rekruttering
- Semmelweis Egyetem
-
Ta kontakt med:
- János Réthelyi, Site 0118
- Telefonnummer: +3612100336
-
Budapest, Ungarn, 1135
- Rekruttering
- Nyírő Gyula Országos Pszichiátriai és Addiktológiai Intézet
-
Ta kontakt med:
- Csaba Almasi, Site 0114
- Telefonnummer: +36 30 604 9696
-
-
Győr-Moson-Sopron
-
Győr, Győr-Moson-Sopron, Ungarn, 9024
- Rekruttering
- Petz Aladar Egyetemi Oktato Korhaz
-
Ta kontakt med:
- Gabor Feller, Site 0116
-
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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 a history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
- Participants must not have a history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: Placebo
|
Specified dose on specified days |
|
Eksperimentell: KarXT
Flexible dosing |
Specified dose on specified days
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Forekomst av respons basert på CGI-BP-endring fra baseline ≥ 1
Tidsramme: I uke 3
|
I uke 3
|
|
|
Forekomst av respons basert på en ≥ 50 % reduksjon fra baseline i YMRS totalpoengsum
Tidsramme: I uke 3
|
I uke 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Bristol-Myers Squibb, Bristol-Myers Squibb
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
11. juni 2025
Primær fullføring (Antatt)
1. november 2026
Studiet fullført (Antatt)
1. november 2026
Datoer for studieregistrering
Først innsendt
23. april 2025
Først innsendt som oppfylte QC-kriteriene
23. april 2025
Først lagt ut (Faktiske)
30. april 2025
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
23. oktober 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. oktober 2026
Sist bekreftet
1. oktober 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CN012-0036
- 2024-520165-32 (Annen identifikator: EU CTR)
- U1111-1316-7438 (Annen identifikator: WHO)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (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
Tilgangskriterier for IPD-deling
See Plan Description
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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