Schizophrenia Clinical Trials

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Effectiveness and Adverse-effect Switch Evaluation

Status: Recruiting
Location: See all (52) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

The purpose of this study is to describe real-world treatment patterns, effectiveness and adverse events of adults diagnosed with schizophrenia that have initiated xanomeline and trospium chloride (KarXT) treatment in the United States

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Participants (or caregiver/legal guardian) must have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved written ICF or signed an electronic ICF in accordance with regulatory, local, and institutional guidelines.

• Adults ≥ 18 years of age at Baseline who are willing and able, in the judgement of the treating clinician, to participate in routine clinical care and follow up.

• Schizophrenia, confirmed by the treating clinician's judgement or physician decision to treat the patient with receiving xanomeline and trospium chloride (KarXT) for schizophrenia made prior to and independently of participation in this study. Current Antipsychotic Treatment: Participant must fall into one of the categories below:

‣ Be within \<16 weeks of initiating treatment with KarXT with intent to discontinue prior antipsychotic treatment(s) OR

⁃ On a stable regimen (dose and frequency consistent with the drug label and/or at a stable dose based on the judgement of the Investigator for at least 30 days prior to screening) of treatment with 1 or more antipsychotics with plan to discontinue and switch to treatment with KarXT from a prior antipsychotic treatments(s). NOTE: The decision to switch for reasons of safety, tolerability, and/or efficacy will be made independently by the treating clinician and/or the patient and is not dictated by the study. Participants can be enrolled during tapering/discontinuing process from prior antipsychotic treatment(s). Individuals who are not currently receiving treatment for schizophrenia are not eligible for the study. Any antipsychotic treatments must be recorded as concomitant medications.

• Concomitant psychiatric medications (eg, antidepressants, mood stabilizers, anxiolytics) are permitted and are recommended to remain at a stable dose during the study period.

Locations
United States
Arkansas
SanRo Clinical Research Group
RECRUITING
Bryant
California
Local Institution - 0003
NOT_YET_RECRUITING
Anaheim
Local Institution - 0047
NOT_YET_RECRUITING
Anaheim
Local Institution - 0039
NOT_YET_RECRUITING
Chino
Local Institution - 0012
NOT_YET_RECRUITING
La Palma
Local Institution - 0043
NOT_YET_RECRUITING
Oceanside
Local Institution - 0028
NOT_YET_RECRUITING
Stanford
Florida
Envision Trials LLC
RECRUITING
Bonita Springs
Galiz Research
RECRUITING
Hialeah
Local Institution - 0030
NOT_YET_RECRUITING
Homestead
New Access Research & Medical Services Inc - Kendall
RECRUITING
Kendall
Banyan Behavioal Care Program - CSU
RECRUITING
Miami
BioResearch Partner - Miami
RECRUITING
Miami
Local Institution - 0007
NOT_YET_RECRUITING
Miami
Local Institution - 0032
NOT_YET_RECRUITING
Miami
Medical Research of Central Florida
RECRUITING
Orange City
Local Institution - 0040
NOT_YET_RECRUITING
Orlando
Georgia
Local Institution - 0025
NOT_YET_RECRUITING
Atlanta
Local Institution - 0049
NOT_YET_RECRUITING
Austell
Local Institution - 0044
NOT_YET_RECRUITING
Marietta
Illinois
Local Institution - 0046
NOT_YET_RECRUITING
Crystal Lake
Local Institution - 0048
NOT_YET_RECRUITING
Warrenville
Michigan
Local Institution - 0014
NOT_YET_RECRUITING
Bloomfield Township
Local Institution - 0036
NOT_YET_RECRUITING
Detroit
Minnesota
Local Institution - 0034
NOT_YET_RECRUITING
Apple Valley
North Carolina
Local Institution - 0042
NOT_YET_RECRUITING
Cary
PPD Virtual - PPD - US
RECRUITING
Wilmington
Nebraska
Local Institution - 0041
NOT_YET_RECRUITING
Lincoln
New York
Local Institution - 0037
NOT_YET_RECRUITING
Buffalo
Local Institution - 0004
NOT_YET_RECRUITING
Monsey
Local Institution - 0038
NOT_YET_RECRUITING
Rochester
Local Institution - 0020
NOT_YET_RECRUITING
White Plains
Ohio
Local Institution - 0031
NOT_YET_RECRUITING
Mason
Oklahoma
The Rivus Wellness & Research Institute
RECRUITING
Oklahoma City
Local Institution - 0052
NOT_YET_RECRUITING
Tulsa
Pennsylvania
Perelman School of Medicine at the University of Pennsylvania
RECRUITING
Philadelphia
Tennessee
Local Institution - 0051
NOT_YET_RECRUITING
Cordova
Psychiatric Consultants, Pc
RECRUITING
Franklin
Texas
Local Institution - 0016
NOT_YET_RECRUITING
Austin
Local Institution - 0050
NOT_YET_RECRUITING
Dallas
Local Institution - 0021
NOT_YET_RECRUITING
Fort Worth
Local Institution - 0010
NOT_YET_RECRUITING
Houston
Local Institution - 0022
NOT_YET_RECRUITING
Houston
Local Institution - 0026
NOT_YET_RECRUITING
Houston
Local Institution - 0033
NOT_YET_RECRUITING
Houston
Pioneer Research Solutions, Inc.
RECRUITING
Houston
Local Institution - 0017
NOT_YET_RECRUITING
Irving
Local Institution - 0013
NOT_YET_RECRUITING
Mckinney
Perceptive Pharma Research
RECRUITING
Richmond
Local Institution - 0035
NOT_YET_RECRUITING
San Antonio
Local Institution - 0018
NOT_YET_RECRUITING
Stafford
Virginia
Local Institution - 0045
NOT_YET_RECRUITING
Petersburg
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain NCT # and Site #.
Time Frame
Start Date: 2026-02-26
Estimated Completion Date: 2028-06-20
Participants
Target number of participants: 1500
Treatments
Group 1
Participants diagnosed with schizophrenia receiving xanomeline and trospium chloride (KarXT)
Related Therapeutic Areas
Sponsors
Leads: Bristol-Myers Squibb

This content was sourced from clinicaltrials.gov