Clinical trial • Phase III • Psychiatry
trospium chloride, xanomeline tartrate for Bipolar I disorder (mania or mania with mixed features)
Phase III trial of trospium chloride, xanomeline tartrate for Bipolar I disorder (mania or mania with mixed features).
Overview
- Trial Therapeutic Area
- Psychiatry
- Trial Disease
- Bipolar I disorder (mania or mania with mixed features)
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 07-05-2025
- First CTIS Authorization Date
- 26-08-2025
Trial design
open-label, none/not specified-controlled Phase III trial across 41 sites in Sweden, Hungary, Croatia and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 278
Eligibility
Recruits 278 No vulnerable populations selected. Only adults aged 18-65 are eligible. Participants must be able to understand the study and agree to take part (informed consent provided by participant). No assent procedures described..
- Pregnancy Exclusion
- Participants cannot join if they have a high risk of suicide or violent behavior, serious heart, liver, or kidney problems, are pregnant or breastfeeding, or have recently used medicines that cannot be safely stopped
- Vulnerable Population
- No vulnerable populations selected. Only adults aged 18-65 are eligible. Participants must be able to understand the study and agree to take part (informed consent provided by participant). No assent procedures described.
Inclusion criteria
- {"criterion_text":"- Participants must be between 18-65 years old.\n- Participant must have a diagnosis of Bipolar-I disorder.\n- If participants are taking lithium, valproate, or lamotrigine, their dose should be stable.\n- Participants must be able to understand the study and agree to take part."}
Exclusion criteria
- {"criterion_text":"- Participants cannot join if they have a high risk of suicide or violent behavior, serious heart, liver, or kidney problems, are pregnant or breastfeeding, or have recently used medicines that cannot be safely stopped\n- The study excludes people with certain conditions that could be made worse by the study drug (due to its cholinergic activities), such as trouble urinating (urinary retention), stomach problems that slow digestion (gastric retention), untreated eye problems (narrow-angle glaucoma), irritable bowel syndrome, or serious constipation\n- Participants will be excluded from the study if they fail a urine drug screen or alcohol test when they come in for screening."}
Endpoints
Primary endpoints
- {"endpoint_text":"- To track any side effects that participants experience while receiving the treatment.","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- To monitor for: serious side effects, specific side effects of concern, side effects that cause participants to stop treatment.","definition_or_measurement_approach":"Monitoring for serious adverse events (SAEs), adverse events of special interest (AESIs), and discontinuations due to side effects."}
- {"endpoint_text":"- To observe any changes in how participants respond to questions about suicidal thoughts or behaviors.","definition_or_measurement_approach":"Observation of changes in responses to questions about suicidal ideation and behavior (questionnaire/assessment-based monitoring)."}
- {"endpoint_text":"- To measure changes from the beginning of the study in: Movement and coordination (using tests like BARS, SAS, and AIMS); Urinary symptoms (for male participants aged 45 and older, using the IPSS questionnaire).","definition_or_measurement_approach":"Movement and coordination assessed using scales/tests such as BARS, SAS, and AIMS; urinary symptoms assessed using the IPSS questionnaire for male participants aged >=45 years."}
Recruitment
- Planned Sample Size
- 278
- Recruitment Window Months
- 33
- Consent Approach
- Informed consent is obtained from the participant (participants must be able to understand the study and agree to take part). ICF/SIS documents and translations are provided for participating countries (documents available in multiple local languages as evidenced by country-specific ICFs and translations, e.g., English, Hungarian, Croatian, Spanish, Polish, Bulgarian, Slovak, Italian). Separate ICFs for pregnant partners and optional future research are provided where applicable.
Geography
- Total Number Of Sites
- 41
- Total Number Of Participants
- 160
Sweden
- Earliest CTIS Part Ii Submission Date
- 30-07-2025
- Latest Decision Or Authorization Date
- 10-02-2026
- Processing Time Days
- 195
- Number Of Sites
- 1
- Number Of Participants
- 5
Sites
- Site Name
- Region Stockholm – SLSO
- Department Name
- Psykiatri Södra Region Stockholm, Lasarettsvägen 6, 131 45 Nacka
- Contact Person Name
- Andreas Carlborg
- Contact Person Email
- andreas.carlborg@regionstockholm.se
Hungary
- Earliest CTIS Part Ii Submission Date
- 07-07-2025
- Latest Decision Or Authorization Date
- 20-02-2026
- Processing Time Days
- 228
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
- Department Name
- Department of Psychiatry, Mental Health and Addiction
- Contact Person Name
- Gabor Feller
- Contact Person Email
- fellerg@petz.gyor.hu
- Site Name
- Semmelweis University
- Department Name
- Department of Psychiatry and Psychotherapy
- Contact Person Name
- Janos Rethelyi
- Contact Person Email
- titkarsag.psych@med.semmelweis-univ.hu
- Site Name
- Nyiro Gyula Orszagos Pszichiatriai Es Addiktologiai Intezet
- Department Name
- Gyula Nyírő National Institute of Psychiatry and Addiction
- Contact Person Name
- Csaba Almasi
- Contact Person Email
- ugyfelszolgalat@nyiro-opai.hu
Croatia
- Earliest CTIS Part Ii Submission Date
- 30-07-2025
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 201
- Number Of Sites
- 4
- Number Of Participants
- 7
Sites
- Site Name
- Klinika za psihijatriju Vrapce
- Department Name
- Zavod za biologijsku psihijatriju i psihogerijatriju
- Contact Person Name
- Ninoslav Mimica
- Contact Person Email
- ninoslav.mimica@bolnica-vrapce.hr
- Site Name
- Clinic for psychiatry Sveti Ivan
- Department Name
- Psychiatry
- Contact Person Name
- Igor Filipcic
- Contact Person Email
- igor.filipcic@kbsvi.hr
- Site Name
- Klinika za psihijatriju Vrapce
- Department Name
- Zavod za psihotične poremećaje ženski
- Contact Person Name
- Miroslav Herceg
- Contact Person Email
- miroslav.herceg@bolnica-vrapce.hr
- Site Name
- Klinika za psihijatriju Vrapce
- Department Name
- Zavod za oporavak i podršku zajednici
- Contact Person Name
- Marko Curkovic
- Contact Person Email
- bolnica@bolnica-vrapce.hr
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 08-07-2025
- Latest Decision Or Authorization Date
- 11-02-2026
- Processing Time Days
- 218
- Number Of Sites
- 6
- Number Of Participants
- 23
Sites
- Site Name
- Center For Mental Health Vratsa EOOD
- Department Name
- Department of General Psychiatry Psychiatry-Level III
- Contact Person Name
- Nadya Ivanova
- Contact Person Email
- nadia_odpzs@abv.bg
- Site Name
- State Psychiatric Saint Ivan Rilski Hospital
- Department Name
- Department of General Psyhiatry-closed type for adult-men Department of General Psyhiatry-closed ty
- Contact Person Name
- Tsveteslava Galabova
- Contact Person Email
- account_kurilo@abv.bg
- Site Name
- MBAL Dr. Ivan Seliminski - Sliven AD
- Department Name
- Department-Psychiatry Level II
- Contact Person Name
- Rozalina Petrova
- Contact Person Email
- mbal.sl@iradeum.com
- Site Name
- "Multiprofile Hospital for Active Treatment Dr. Hristo Stambolski" EOOD, Kazanlak
- Department Name
- Psychiatry Level II
- Contact Person Name
- Ivan Dimitrov
- Contact Person Email
- itdim@abv.bg
- Site Name
- University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
- Department Name
- First Psychiatric Clinic-Psychiatry Level III
- Contact Person Name
- Maya Stoimenova-Popova
- Contact Person Email
- kopfemale_pln@abv.bg
- Site Name
- Center For Mental Health Prof. Dr. Ivan Temkov Burgas EOOD
- Department Name
- Department for Treatment of Emergency Psychiatric Conditions - Psychiatry Level III
- Contact Person Name
- Veselin Palazov
- Contact Person Email
- cpz_burgas@abv.bg
Romania
- Earliest CTIS Part Ii Submission Date
- 25-07-2025
- Latest Decision Or Authorization Date
- 16-03-2026
- Processing Time Days
- 234
- Number Of Sites
- 10
- Number Of Participants
- 60
Sites
- Site Name
- Centru De Evaluare Si Tratament A Toxicodependentelor Pentru Tineri Sf. Stelian
- Department Name
- Psihiatry
- Contact Person Name
- Traian Barbu
- Contact Person Email
- abc@yahoo.com
- Site Name
- Institutul Național de Gerontologie și Geriatrie "Ana Aslan"
- Department Name
- Psihiatry
- Contact Person Name
- Traian Purnichi
- Contact Person Email
- traian.purnichi@gmail.com
- Site Name
- Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
- Department Name
- Psihiatry
- Contact Person Name
- Laura Cristina Dolis
- Contact Person Email
- secretariat@spital-obregia.ro
- Site Name
- Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
- Department Name
- Psihiatry
- Contact Person Name
- Valentin Matei
- Contact Person Email
- secretariat@spital-obregia.ro
- Site Name
- Institutul De Psihiatrie Socola Iasi
- Department Name
- Psihiatry
- Contact Person Name
- Cristian Stefanescu
- Contact Person Email
- secretariat@socola.eu
- Site Name
- Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
- Department Name
- Psihiatry
- Contact Person Name
- Mihnea Manea
- Contact Person Email
- secretariat@spital-obregia.ro
- Site Name
- Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
- Department Name
- Psihiatry
- Contact Person Name
- Corina Mihaela Nicolae
- Contact Person Email
- secretariat@spital-obregia.ro
- Site Name
- Spitalul Clinic De Psihiatrie Prof.Dr.Alexandru Obregia
- Department Name
- Psihiatry
- Contact Person Name
- Adela Magdalena Ciobanu
- Contact Person Email
- secretariat@spital-obregia.ro
- Site Name
- Spitalul Clinic De Psihiatrie Si Neurologie Brasov
- Department Name
- Psihiatry
- Contact Person Name
- Petru Ifteni
- Contact Person Email
- petru_ifteni@yahoo.com
- Site Name
- Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila
- Department Name
- Psihiatry
- Contact Person Name
- Octavian Vasiliu
- Contact Person Email
- abc@yahoo.com
Spain
- Earliest CTIS Part Ii Submission Date
- 16-06-2025
- Latest Decision Or Authorization Date
- 13-02-2026
- Processing Time Days
- 242
- Number Of Sites
- 3
- Number Of Participants
- 6
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Psychiatry
- Contact Person Name
- Josep Antoni Ramos-Quiroga
- Contact Person Email
- jaramos@vhebron.net
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Psychiatry and Psychology
- Contact Person Name
- Eduard Vieta
- Contact Person Email
- evieta@clinic.cat
- Site Name
- Hospital Universitario Basurto
- Department Name
- Psychiatry
- Contact Person Name
- Ana Catalán
- Contact Person Email
- xxxx@xxxx.xx
Slovakia
- Earliest CTIS Part Ii Submission Date
- 22-08-2025
- Latest Decision Or Authorization Date
- 09-03-2026
- Processing Time Days
- 199
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- Crystal Comfort s.r.o.
- Department Name
- Psychiatry
- Contact Person Name
- Dagmar Breznoscakova
- Contact Person Email
- tkraviarova@gmail.com
- Site Name
- Epamed s.r.o.
- Department Name
- Psychiatry
- Contact Person Name
- Eva Palova
- Contact Person Email
- epamed.ke@gmail.com
- Site Name
- Univerzitna nemocnica L. Pasteura Kosice
- Department Name
- Psychiatry
- Contact Person Name
- Slavka Dubinska
- Contact Person Email
- slavka.dubinska@unlp.sk
Italy
- Earliest CTIS Part Ii Submission Date
- 24-04-2026
- Latest Decision Or Authorization Date
- 14-05-2026
- Processing Time Days
- 20
- Number Of Sites
- 5
- Number Of Participants
- 12
Sites
- Site Name
- Azienda Ospedaliero-Universitaria Senese
- Department Name
- U.O.C. Psichiatria
- Contact Person Name
- Andrea Fagiolini
- Contact Person Email
- andrea.fagiolini@unisi.it
- Site Name
- Azienda Ospedaliero Universitaria Delle Marche
- Department Name
- Clinica Psichiatrica
- Contact Person Name
- Umberto Volpe
- Contact Person Email
- u.volpe@staff.univpm.it
- Site Name
- Azienda Ospedaliero Universitaria Pisana
- Department Name
- UO Psichiatria 2
- Contact Person Name
- Giulio Perugi
- Contact Person Email
- giulio.perugi@unipi.it
- Site Name
- IRCCS Azienda Ospedaliera Metropolitana
- Department Name
- Clinica Psichiatrica
- Contact Person Name
- Gianluca Serafini
- Contact Person Email
- Gianluca.Serafini@unige.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- SC Psichiatria
- Contact Person Name
- Paolo Brambilla
- Contact Person Email
- paolo.brambilla@policlinico.mi.it
Poland
- Earliest CTIS Part Ii Submission Date
- 01-08-2025
- Latest Decision Or Authorization Date
- 20-03-2026
- Processing Time Days
- 231
- Number Of Sites
- 6
- Number Of Participants
- 34
Sites
- Site Name
- Instytut Psychiatrii I Neurologii
- Department Name
- III Klinika Psychiatryczna
- Contact Person Name
- Adam Wichniak
- Contact Person Email
- wichniak@ipin.edu.pl
- Site Name
- Centrum Medyczne Hcp Sp. z o.o.
- Department Name
- Oddzial Dzienny Psychiatryczny
- Contact Person Name
- Sylwia Szymkowiak
- Contact Person Email
- sylwia.szymkowiak@cmhcp.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Bialymstoku
- Department Name
- Klinika Psychiatry
- Contact Person Name
- Napoleon Waszkiewicz
- Contact Person Email
- napwas@wp.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Psychiatryi Dorosłych
- Contact Person Name
- Wieslaw Jerzy Cubala
- Contact Person Email
- cubala@gumed.edu.pl
- Site Name
- NZOZ Prywatna Klinika Psychiatryczna INVENTIVA
- Contact Person Name
- Sylwester Strzelec
- Contact Person Email
- sekretariat@klinika-inventiva.pl
- Site Name
- M2M Med. Sp. z o.o. Sp. j.
- Department Name
- Oddział w Rybniku
- Contact Person Name
- Wojciech Eysymontt
- Contact Person Email
- w.eysymontt@m2m-badania.pl
Sponsor
Primary sponsor
- Full Name
- Bristol-Myers Squibb Services Unlimited Company
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Ireland
Contract research organisations
- Name
- Syneos Health Clinique Inc.
- Responsibilities
- PK Analysis
- Name
- EndPoint Clinical Inc.
- Responsibilities
- Subject Number Assignment, Treatment/Arm Assignment, Drug (re) Supplies Assignment
- Name
- Iqvia Inc.
- Responsibilities
- Managing site payments
- Name
- WCG Clinical Inc.
- Responsibilities
- COA licensing and translations, Rater training
- Name
- Medidata Solutions Inc.
- Responsibilities
- 6
Third parties
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central Lab, Clinical chemistry,haematology and microbiology","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"COA licensing and translations, Rater training","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"Central Lab, Clinical chemistry,haematology and microbiology","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"submission administrative support","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"6","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Canada","full_name":"Syneos Health Clinique Inc.","duties_or_roles":"PK Analysis","organisation_type":"Hospital/Clinic/Other health care facility"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Pharmacovigilance duties: Medical review and Cases Data Entry","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Provides electronic payments, travel arrangements,electronic study-related comunications to patients","organisation_type":"Non-Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Embarc operations","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Managing site payments","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"eCOA rater station development, eCOA data review, PRO/COA licensing and translations; Rater training","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"EndPoint Clinical Inc.","duties_or_roles":"Subject Number Assignment, Treatment/Arm Assignment, Drug (re) Supplies Assignment","organisation_type":"Health care"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"PK Analysis","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Azenta US Inc.","duties_or_roles":"Sample storage for Biomarker and PK samples","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- KarXT
- Active Substance
- trospium chloride, xanomeline tartrate
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Authorisation Status
- Authorised (prodAuthStatus=1)
- Combination Treatment
- Yes
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