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CompletedNCT05145413

Safety study of Safety and Efficacy of Adjunctive KarXT in schizophrenia

This study is completed in the United States, in the United Kingdom, in Bulgaria, .... It is testing Safety and Efficacy of Adjunctive KarXT for schizophrenia.

SchizophreniaDrugFrom 18 Years to 65 Years

The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.

Then choose your country and confirm availability with each study site.

In plain English

Key information made simple

What is this study testing?

This study is testing whether Adjunctive KarXT may be useful for adults experiencing schizophrenia.

What would participation involve?

Participants may receive Adjunctive KarXT, attend study visits with the research team. The protocol may also involve randomization, placebo, or a comparison group. The registry lists locations in Bulgaria, in India, and in Japan.

Who is it mainly for?

This study appears to be mainly for adults with schizophrenia.

What should you check before joining?

Ask about the dose, safety monitoring, and possible side effects, whether there is placebo, randomization, or a comparison group, how many visits or travel steps are needed, the exact eligibility criteria.

Your next step

Check the study details

Check the official source, then confirm these points with the research team.

View official study record (opens in a new tab)
  • Recruitment and eligibility

    Is a site open, and who can take part?

  • Visits and time

    Where are visits, can any be remote, and how much time is needed?

  • Costs and support

    What costs, reimbursement or compensation apply?

Before joining

Questions to ask before joining

Study clarity

Things to check before joining

Study start dateStarted: November 12, 2021
Recruitment status
Completed
Enrollment listed in the registry
396
Sponsor
Karuna Therapeutics, Inc., a Bristol Myers Squibb company
Sponsor type
Biotech company
Study type
Drug
Intervention type
Medication / drug
Study phase
Phase 3Usually a larger study designed to confirm effectiveness and safety in a broader group.
Locations
United States, United Kingdom, Bulgaria, ...
Age range
From 18 Years to 65 Years
Official registry ID
NCT05145413
Official title
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia

Check recruitment and locations

Recruitment checked against the registry by HopeStage on . Registry information can change. Always confirm availability with the research team.

View official study record (opens in a new tab)

The overall study status can differ from each site's status. Open a country to see its locations and their registry status.

Bulgaria · 21 sites
  • MHAT Dr. Hristo Stambolski, EOOD
    Kazanlak, Stara Zagora
    Site status: Not listed — confirm with the team
  • Ambulatory for Individual Practice for Specialized Medical Care in Psychiatry - Dr Ivo Natsov
    Cherven Bryag
    Site status: Not listed — confirm with the team
  • Medical Centre 'Asklepii', OOD
    Dupnitsa
    Site status: Not listed — confirm with the team
  • Medical Center Lifemed
    Kardzhali
    Site status: Not listed — confirm with the team
  • State Psychiatric Hospital 'Sv. Ivan Rilski', Novi Iskar
    Novi Iskar
    Site status: Not listed — confirm with the team
  • Medical Center Medconsult Pleven OOD
    Pleven
    Site status: Not listed — confirm with the team
  • UMHAT 'Dr. Georgi Stranski', EAD
    Pleven
    Site status: Not listed — confirm with the team
  • UMHAT Sv. Georgi, EAD
    Plovdiv
    Site status: Not listed — confirm with the team
  • Local Institution - 321
    Plovdiv
    Site status: Not listed — confirm with the team
  • Local Institution - 313
    Razgrad
    Site status: Not listed — confirm with the team
  • MHAT Dr Ivan Seliminski AD
    Sliven
    Site status: Not listed — confirm with the team
  • Medical Center 'Sv.Naum'
    Sofia
    Site status: Not listed — confirm with the team
  • MHC - Sofia, EOOD
    Sofia
    Site status: Not listed — confirm with the team
  • Local Institution - 320
    Sofia
    Site status: Not listed — confirm with the team
  • DCC 'Sv. Vrach and Sv. Sv. Kuzma and Damyan', OOD
    Sofia
    Site status: Not listed — confirm with the team
  • Medical Center Akademika EOOD
    Sofia
    Site status: Not listed — confirm with the team
  • Medical Center Hera EOOD
    Sofia
    Site status: Not listed — confirm with the team
  • Medical Center Intermedica, OOD
    Sofia
    Site status: Not listed — confirm with the team
  • Medical Center VAS OOD
    Targovishte
    Site status: Not listed — confirm with the team
  • DCC Mladost M - Varna, OOD
    Varna
    Site status: Not listed — confirm with the team
  • Mental Health Center-Vratsa EOOD
    Vratsa
    Site status: Not listed — confirm with the team
India · 19 sites
  • Local Institution - 616
    Guwahati, Assam
    Site status: Not listed — confirm with the team
  • Local Institution - 607
    Ahmedabad, Gujarat
    Site status: Not listed — confirm with the team
  • Local Institution - 604
    Ahmedabad, Gujarat
    Site status: Not listed — confirm with the team
  • Local Institution - 609
    Surat, Gujarat
    Site status: Not listed — confirm with the team
  • Local Institution - 613
    Vadodara, Gujarat
    Site status: Not listed — confirm with the team
  • Local Institution - 617
    Belgavi, Karnataka
    Site status: Not listed — confirm with the team
  • Local Institution - 614
    Mangalore, Karnataka
    Site status: Not listed — confirm with the team
  • Local Institution - 602
    Mangalore, Karnataka
    Site status: Not listed — confirm with the team
  • Local Institution - 601
    Mysore, Karnataka
    Site status: Not listed — confirm with the team
  • Local Institution - 611
    Kozhikode, Kerala
    Site status: Not listed — confirm with the team
  • Local Institution - 610
    Aurangabad, Maharashtra
    Site status: Not listed — confirm with the team
  • Local Institution - 619
    Mumbai, Maharashtra
    Site status: Not listed — confirm with the team
  • Local Institution - 603
    Nagpur, Maharashtra
    Site status: Not listed — confirm with the team
  • Local Institution - 608
    Nashik, Maharashtra
    Site status: Not listed — confirm with the team
  • Local Institution - 605
    Nashik, Maharashtra
    Site status: Not listed — confirm with the team
  • Local Institution - 615
    Ajmer, Rajasthan
    Site status: Not listed — confirm with the team
  • Local Institution - 618
    Bikaner, Rajasthan
    Site status: Not listed — confirm with the team
  • Local Institution - 606
    Rajkot, Rajasthan
    Site status: Not listed — confirm with the team
  • Local Institution - 612
    Lucknow, Uttar Pradesh
    Site status: Not listed — confirm with the team
Japan · 6 sites
  • Local Institution - 258
    Kōnan, Aichi-ken
    Site status: Not listed — confirm with the team
  • Local Institution - 250
    Toyoake-shi, Aichi-ken
    Site status: Not listed — confirm with the team
  • Local Institution - 257
    Shirakawa, Fukushima
    Site status: Not listed — confirm with the team
  • Local Institution - 254
    Karatsu-shi, Saga-ken
    Site status: Not listed — confirm with the team
  • Local Institution - 255
    Fukuoka
    Site status: Not listed — confirm with the team
  • Local Institution - 256
    Tokyo
    Site status: Not listed — confirm with the team
Poland · 9 sites
  • Local Institution - 506
    Bialystok
    Site status: Not listed — confirm with the team
  • Local Institution - 507
    Gdansk
    Site status: Not listed — confirm with the team
  • Local Institution - 509
    Grudziądz
    Site status: Not listed — confirm with the team
  • Local Institution - 501
    Kielce
    Site status: Not listed — confirm with the team
  • Local Institution - 503
    Lodz
    Site status: Not listed — confirm with the team
  • Local Institution - 505
    Lublin
    Site status: Not listed — confirm with the team
  • Local Institution - 502
    Siemianowice Śląskie
    Site status: Not listed — confirm with the team
  • Local Institution - 508
    Suchy Las
    Site status: Not listed — confirm with the team
  • Local Institution - 504
    Tuszyn
    Site status: Not listed — confirm with the team
Romania · 10 sites
  • Local Institution - 803
    Brasov
    Site status: Not listed — confirm with the team
  • Local Institution - 809
    Bucharest
    Site status: Not listed — confirm with the team
  • Local Institution - 804
    Bucharest
    Site status: Not listed — confirm with the team
  • Local Institution - 810
    Bucharest
    Site status: Not listed — confirm with the team
  • Local Institution - 802
    Bucharest
    Site status: Not listed — confirm with the team
  • Local Institution - 807
    Bucharest
    Site status: Not listed — confirm with the team
  • Local Institution - 808
    Craiova
    Site status: Not listed — confirm with the team
  • Local Institution - 801
    Galati
    Site status: Not listed — confirm with the team
  • Local Institution - 806
    Iași
    Site status: Not listed — confirm with the team
  • Local Institution - 805
    Sibiu
    Site status: Not listed — confirm with the team
Serbia · 12 sites
  • Clinical Center ' Dr Dragisa Misovic Dedinje'
    Belgrade
    Site status: Not listed — confirm with the team
  • Institute of Mental Health
    Belgrade
    Site status: Not listed — confirm with the team
  • Local Institution - 413
    Belgrade
    Site status: Not listed — confirm with the team
  • Local Institution - 417
    Belgrade
    Site status: Not listed — confirm with the team
  • University Clinical Center of Serbia
    Belgrade
    Site status: Not listed — confirm with the team
  • "Special Hospital for Psychiatric Diseases ""Kovin"""
    Kovin
    Site status: Not listed — confirm with the team
  • Special Hospital for Psychiatric Diseases 'Kovin'
    Kovin
    Site status: Not listed — confirm with the team
  • University Clinical Center Kragujevac
    Kragujevac
    Site status: Not listed — confirm with the team
  • University Clinical Center Nis
    Niš
    Site status: Not listed — confirm with the team
  • Special Hospital for Psychiatric Diseases 'Gornja Toponica'
    Niš
    Site status: Not listed — confirm with the team
  • Special Hospital for Psychiatric Diseases 'Sveti Vracevi'
    Novi Kneževac
    Site status: Not listed — confirm with the team
  • Special Hospital for Psychiatric Disease 'Dr Slavoljub Bakalovic'
    Vršac
    Site status: Not listed — confirm with the team
United Kingdom · 10 sites
  • Local Institution - 707
    Pool, Reruth, Cornwall
    Site status: Not listed — confirm with the team
  • Local Institution - 705
    Brighton, East Sussex
    Site status: Not listed — confirm with the team
  • Local Institution - 701
    London, Greater London
    Site status: Not listed — confirm with the team
  • Local Institution - 706
    Ashton-under-Lyne, Greater Manchester
    Site status: Not listed — confirm with the team
  • Local Institution - 710
    Manchester, Greater Manchester
    Site status: Not listed — confirm with the team
  • Local Institution - 709
    Maidstone, Kent
    Site status: Not listed — confirm with the team
  • Local Institution - 708
    Oxford, Oxfordshire
    Site status: Not listed — confirm with the team
  • Local Institution - 704
    Glasgow, Strathclyde
    Site status: Not listed — confirm with the team
  • Local Institution - 702
    Chertsey, Surrey
    Site status: Not listed — confirm with the team
  • Local Institution - 703
    Birmingham, West Midlands
    Site status: Not listed — confirm with the team
United States · 79 sites
  • IMA Clinical Research
    Phoenix, Arizona
    Site status: Not listed — confirm with the team
  • Local Institution - 147
    Phoenix, Arizona
    Site status: Not listed — confirm with the team
  • Pillar Clinical Research, LLC
    Little Rock, Arkansas
    Site status: Not listed — confirm with the team
  • Woodland International Research Group, LLC
    Little Rock, Arkansas
    Site status: Not listed — confirm with the team
  • Advanced Research Center, Inc.
    Anaheim, California
    Site status: Not listed — confirm with the team
  • CITrials - Bellflower
    Bellflower, California
    Site status: Not listed — confirm with the team
  • Synexus Clinical Research US, Inc.
    Cerritos, California
    Site status: Not listed — confirm with the team
  • Clinical Innovations Inc.
    Costa Mesa, California
    Site status: Not listed — confirm with the team
  • Proscience Research Group
    Culver City, California
    Site status: Not listed — confirm with the team
  • CenExel Collaborative Neuroscience Research
    Garden Grove, California
    Site status: Not listed — confirm with the team
  • Omega Clinical Trials
    La Habra, California
    Site status: Not listed — confirm with the team
  • Sunwise Clinical Research, LLC.
    Lafayette, California
    Site status: Not listed — confirm with the team
  • Synergy Clinical Research of Escondido
    Lemon Grove, California
    Site status: Not listed — confirm with the team
  • Encino Hospital Medical Center
    Los Angeles, California
    Site status: Not listed — confirm with the team
  • Excell Research, Inc.
    Oceanside, California
    Site status: Not listed — confirm with the team
  • Neuropsychiatric Research Center of Orange County
    Orange, California
    Site status: Not listed — confirm with the team
  • CNRI - Los Angeles, LLC
    Pico Rivera, California
    Site status: Not listed — confirm with the team
  • CenExel Clinical Innovations, Inc.
    Riverside, California
    Site status: Not listed — confirm with the team
  • Cnri-San Diego
    San Diego, California
    Site status: Not listed — confirm with the team
  • Stanford University School of Medicine
    Stanford, California
    Site status: Not listed — confirm with the team
  • CenExel Collaborative Neuroscience Research
    Torrance, California
    Site status: Not listed — confirm with the team
  • Local Institution - 186
    Coral Gables, Florida
    Site status: Not listed — confirm with the team
  • Reliable Clinical Research LLC
    Hialeah, Florida
    Site status: Not listed — confirm with the team
  • Galiz Research, LLC
    Hialeah, Florida
    Site status: Not listed — confirm with the team
  • Adaptive Clinical Research, Inc
    Lauderhill, Florida
    Site status: Not listed — confirm with the team
  • Behavioral Clinical Research , Inc
    Miami, Florida
    Site status: Not listed — confirm with the team
  • Premier Clinical Research Institute, Inc.
    Miami, Florida
    Site status: Not listed — confirm with the team
  • San Marcus Research Clinic, Inc.
    Miami Lakes, Florida
    Site status: Not listed — confirm with the team
  • Assertive Research Center
    Miami Lakes, Florida
    Site status: Not listed — confirm with the team
  • Envision Trials LLC
    Miami Springs, Florida
    Site status: Not listed — confirm with the team
  • Local Institution - 124
    Orange City, Florida
    Site status: Not listed — confirm with the team
  • Pines Care Research Center, Inc.
    Pembroke Pines, Florida
    Site status: Not listed — confirm with the team
  • Interventional Psychiatry of Tampa Bay
    Tampa, Florida
    Site status: Not listed — confirm with the team
  • Grady Memorial Hospital
    Atlanta, Georgia
    Site status: Not listed — confirm with the team
  • Synexus Clinical Research US, Inc.
    Atlanta, Georgia
    Site status: Not listed — confirm with the team
  • Local Institution - 192
    Atlanta, Georgia
    Site status: Not listed — confirm with the team
  • Local Institution - 135
    Augusta, Georgia
    Site status: Not listed — confirm with the team
  • CenExel iResearch Atlanta
    Decatur, Georgia
    Site status: Not listed — confirm with the team
  • Psych Atlanta, P.C.
    Marietta, Georgia
    Site status: Not listed — confirm with the team
  • CenExel iResearch, LLC
    Savannah, Georgia
    Site status: Not listed — confirm with the team
  • Northwestern University
    Chicago, Illinois
    Site status: Not listed — confirm with the team
  • American Medical Research, Inc.
    Chicago, Illinois
    Site status: Not listed — confirm with the team
  • Uptown Research Institute, LLC
    Chicago, Illinois
    Site status: Not listed — confirm with the team
  • Phoenix Medical Research, Inc.
    Prairie Village, Kansas
    Site status: Not listed — confirm with the team
  • IMA Clinical Research
    Monroe, Louisiana
    Site status: Not listed — confirm with the team
  • CenExel Center for Behavioral Health
    Gaithersburg, Maryland
    Site status: Not listed — confirm with the team
  • Local Institution - 158
    Boston, Massachusetts
    Site status: Not listed — confirm with the team
  • Local Institution - 187
    Boston, Massachusetts
    Site status: Not listed — confirm with the team
  • Local Institution - 185
    Worcester, Massachusetts
    Site status: Not listed — confirm with the team
  • Michigan Clinical Research Institute PC
    Ann Arbor, Michigan
    Site status: Not listed — confirm with the team
  • Cherry Health
    Grand Rapids, Michigan
    Site status: Not listed — confirm with the team
  • Western Michigan University Homer Stryker M.D. School of Medicine
    Kalamazoo, Michigan
    Site status: Not listed — confirm with the team
  • Local Institution - 129
    St Louis, Missouri
    Site status: Not listed — confirm with the team
  • Arch Clinical Trials LLC
    St Louis, Missouri
    Site status: Not listed — confirm with the team
  • Omaha Insomnia and Psychiatric Services LLC
    Omaha, Nebraska
    Site status: Not listed — confirm with the team
  • Altea Research Institute, Las Vegas
    Las Vegas, Nevada
    Site status: Not listed — confirm with the team
  • CenExel Hassman Research Institute
    Berlin, New Jersey
    Site status: Not listed — confirm with the team
  • Synexus Clinical Research US, Inc.
    New York, New York
    Site status: Not listed — confirm with the team
  • Manhattan Psychiatric Center
    New York, New York
    Site status: Not listed — confirm with the team
  • Manhattan Behavioral Medicine, PLLC
    New York, New York
    Site status: Not listed — confirm with the team
  • Psychiatry and Alzheimer's Care of Rochester. PLLC
    Rochester, New York
    Site status: Not listed — confirm with the team
  • Richmond Behavioral Associates ERG Clinical Research - New York PLLC
    Staten Island, New York
    Site status: Not listed — confirm with the team
  • Clinical Trials of America - Psychiatry
    Hickory, North Carolina
    Site status: Not listed — confirm with the team
  • University of Cincinnati Medical Center
    Cincinnati, Ohio
    Site status: Not listed — confirm with the team
  • Local Institution - 168
    Garfield Heights, Ohio
    Site status: Not listed — confirm with the team
  • Insight Clinical Trials LLC
    Independence, Ohio
    Site status: Not listed — confirm with the team
  • The Rivus Wellness & Research Institute
    Oklahoma City, Oklahoma
    Site status: Not listed — confirm with the team
  • Prevention Science Institute
    Eugene, Oregon
    Site status: Not listed — confirm with the team
  • Community Clinical Research, Inc.
    Austin, Texas
    Site status: Not listed — confirm with the team
  • InSite Clinical Research; LLC
    DeSoto, Texas
    Site status: Not listed — confirm with the team
  • JPS Health Network
    Fort Worth, Texas
    Site status: Not listed — confirm with the team
  • Ben Taub Hospital
    Houston, Texas
    Site status: Not listed — confirm with the team
  • Clinical Trial Network LLC
    Houston, Texas
    Site status: Not listed — confirm with the team
  • University Hills Clinical Research - Irving
    Irving, Texas
    Site status: Not listed — confirm with the team
  • Pillar Clinical Research, LLC
    Richardson, Texas
    Site status: Not listed — confirm with the team
  • At Health Texas
    Richmond, Texas
    Site status: Not listed — confirm with the team
  • Perceptive Pharma Research
    Richmond, Texas
    Site status: Not listed — confirm with the team
  • Green Mountain Research Institute
    Rutland, Vermont
    Site status: Not listed — confirm with the team
  • Northwest Clinical Research Center
    Bellevue, Washington
    Site status: Not listed — confirm with the team

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In practice

For you

Participation may contribute to research. Personal benefit is not guaranteed.

Ask the research team to explain the activities, time commitment, and follow-up involved.

Study sites are listed. Confirm the relevant site and any travel before making plans.

Important

Not medical advice

Information from public sources. Are you the study sponsor? Contact us to update this page: hi@hopestage.com

FAQ

Questions about this study

What is this study trying to understand?

This study is exploring medication or study treatment for people with schizophrenia. Participants may complete study visits, assessments, or follow-up activities defined by the research team. Direct benefit is not guaranteed. The detailed objective is not always clearly listed in the public registry; the study team can confirm.

Does this study involve a medication?

This appears to be a medication / drug study involving Xanomeline and Trospium Chloride Capsules, Placebo. Phase 3 studies are usually larger and aim to confirm effectiveness and safety in a broader group.

Who might this study be for?

This study may concern people with schizophrenia; age range: From 18 Years to 65 Years. The criteria appear fairly specific, but you should not assume you are eligible. The study team must confirm diagnosis, age, exclusions, available locations, and next steps.

What would I likely need to do?

You may need to take a study treatment and have regular medical follow-up. The listed study locations suggest that at least part of participation may involve a physical site. Ask whether some steps can be done remotely.

What side effects, interactions, or treatment changes should I check?

If the study involves a medication, ask whether it is already approved, experimental, or being tested for a new use. Check possible side effects, interactions with current treatment, dose changes, monitoring, and what happens if you feel worse. For any mental health study, also ask who to contact if you feel worse, whether participation may affect current treatment, whether you can stop, and who confirms eligibility.

Will I need to travel or attend in-person visits?

The listed study locations suggest that at least part of participation may involve a physical site. Ask which sites are open, how many visits are expected, whether any steps can be done remotely, and whether travel costs or compensation are listed.

Who is behind this study?

This study is sponsored by Karuna Therapeutics, Inc., a Bristol Myers Squibb company, which appears to be a biotech company. If available, it can be useful to check the sponsor website, collaborators, investigator affiliation, and the official registry before deciding. HopeStage does not judge the quality of a sponsor or researcher, but helps you identify what to verify.

Can I still join this study?

The public registry lists this study as not currently recruiting. This page remains available for information. Check the official record for the latest status and explore other recruiting studies.

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