A Study to Assess Efficacy and Safety of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
Public ClinicalTrials.gov record NCT05145413. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase 3, 6-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with schizophrenia with an inadequate response to their current atypical antipsychotic treatment. The primary objective of the study is to assess the efficacy of adjunctive KarXT (a fixed dose combination of xanomeline and trospium chloride twice daily \[BID\]) versus placebo in the treatment of subjects with inadequately controlled symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) Total Score.
Study identification
- NCT ID
- NCT05145413
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 396 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 12, 2021 (Actual)
- Primary completion
- Mar 19, 2025 (Actual)
- Completion
- Mar 19, 2025 (Actual)
- Last update posted
- May 5, 2026
2021 – 2025
United States locations
- U.S. sites
- 79
- U.S. states
- 23
- U.S. cities
- 64
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| IMA Clinical Research | Phoenix | Arizona | 85012 | — |
| Local Institution - 147 | Phoenix | Arizona | 85012 | — |
| Pillar Clinical Research, LLC | Little Rock | Arkansas | 72204 | — |
| Woodland International Research Group, LLC | Little Rock | Arkansas | 72211 | — |
| Advanced Research Center, Inc. | Anaheim | California | 92805 | — |
| CITrials - Bellflower | Bellflower | California | 90706-7079 | — |
| Synexus Clinical Research US, Inc. | Cerritos | California | 90703 | — |
| Clinical Innovations Inc. | Costa Mesa | California | 92626 | — |
| Proscience Research Group | Culver City | California | 90230 | — |
| CenExel Collaborative Neuroscience Research | Garden Grove | California | 92845 | — |
| Omega Clinical Trials | La Habra | California | 90631 | — |
| Sunwise Clinical Research, LLC. | Lafayette | California | 94549 | — |
| Synergy Clinical Research of Escondido | Lemon Grove | California | 91945 | — |
| Encino Hospital Medical Center | Los Angeles | California | 91403 | — |
| Excell Research, Inc. | Oceanside | California | 92056 | — |
| Neuropsychiatric Research Center of Orange County | Orange | California | 92868 | — |
| CNRI - Los Angeles, LLC | Pico Rivera | California | 90660 | — |
| CenExel Clinical Innovations, Inc. | Riverside | California | 92506 | — |
| Cnri-San Diego | San Diego | California | 92123 | — |
| Stanford University School of Medicine | Stanford | California | 94305 | — |
| CenExel Collaborative Neuroscience Research | Torrance | California | 90504 | — |
| Local Institution - 186 | Coral Gables | Florida | 33134 | — |
| Reliable Clinical Research LLC | Hialeah | Florida | 33012 | — |
| Galiz Research, LLC | Hialeah | Florida | 33016-1814 | — |
| Adaptive Clinical Research, Inc | Lauderhill | Florida | 33319-4985 | — |
| Behavioral Clinical Research , Inc | Miami | Florida | 33016 | — |
| Premier Clinical Research Institute, Inc. | Miami | Florida | 33122 | — |
| San Marcus Research Clinic, Inc. | Miami Lakes | Florida | 33014 | — |
| Assertive Research Center | Miami Lakes | Florida | 33016 | — |
| Envision Trials LLC | Miami Springs | Florida | 33166 | — |
| Local Institution - 124 | Orange City | Florida | 32763 | — |
| Pines Care Research Center, Inc. | Pembroke Pines | Florida | 33024 | — |
| Interventional Psychiatry of Tampa Bay | Tampa | Florida | 33629 | — |
| Grady Memorial Hospital | Atlanta | Georgia | 30303 | — |
| Synexus Clinical Research US, Inc. | Atlanta | Georgia | 30328 | — |
| Local Institution - 192 | Atlanta | Georgia | 30331 | — |
| Local Institution - 135 | Augusta | Georgia | 30912 | — |
| CenExel iResearch Atlanta | Decatur | Georgia | 30030 | — |
| Psych Atlanta, P.C. | Marietta | Georgia | 30060 | — |
| CenExel iResearch, LLC | Savannah | Georgia | 31405 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| American Medical Research, Inc. | Chicago | Illinois | 60612-2307 | — |
| Uptown Research Institute, LLC | Chicago | Illinois | 60640 | — |
| Phoenix Medical Research, Inc. | Prairie Village | Kansas | 66208 | — |
| IMA Clinical Research | Monroe | Louisiana | 71201-2986 | — |
| CenExel Center for Behavioral Health | Gaithersburg | Maryland | 20877 | — |
| Local Institution - 158 | Boston | Massachusetts | 02114 | — |
| Local Institution - 187 | Boston | Massachusetts | 02118 | — |
| Local Institution - 185 | Worcester | Massachusetts | 01655 | — |
| Michigan Clinical Research Institute PC | Ann Arbor | Michigan | 48105 | — |
| Cherry Health | Grand Rapids | Michigan | 49548-6927 | — |
| Western Michigan University Homer Stryker M.D. School of Medicine | Kalamazoo | Michigan | 49001 | — |
| Local Institution - 129 | St Louis | Missouri | 63128 | — |
| Arch Clinical Trials LLC | St Louis | Missouri | 63141 | — |
| Omaha Insomnia and Psychiatric Services LLC | Omaha | Nebraska | 68144 | — |
| Altea Research Institute, Las Vegas | Las Vegas | Nevada | 89102 | — |
| CenExel Hassman Research Institute | Berlin | New Jersey | 08009 | — |
| Synexus Clinical Research US, Inc. | New York | New York | 10017 | — |
| Manhattan Psychiatric Center | New York | New York | 10027 | — |
| Manhattan Behavioral Medicine, PLLC | New York | New York | 10036 | — |
| Psychiatry and Alzheimer's Care of Rochester. PLLC | Rochester | New York | 14623 | — |
| Richmond Behavioral Associates ERG Clinical Research - New York PLLC | Staten Island | New York | 10314 | — |
| Clinical Trials of America - Psychiatry | Hickory | North Carolina | 28601 | — |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | — |
| Local Institution - 168 | Garfield Heights | Ohio | 44125 | — |
| Insight Clinical Trials LLC | Independence | Ohio | 44131 | — |
| The Rivus Wellness & Research Institute | Oklahoma City | Oklahoma | 73112 | — |
| Prevention Science Institute | Eugene | Oregon | 97403 | — |
| Community Clinical Research, Inc. | Austin | Texas | 78754 | — |
| InSite Clinical Research; LLC | DeSoto | Texas | 75115 | — |
| JPS Health Network | Fort Worth | Texas | 76104 | — |
| Ben Taub Hospital | Houston | Texas | 77030 | — |
| Clinical Trial Network LLC | Houston | Texas | 77074 | — |
| University Hills Clinical Research - Irving | Irving | Texas | 75062 | — |
| Pillar Clinical Research, LLC | Richardson | Texas | 75080 | — |
| At Health Texas | Richmond | Texas | 77407 | — |
| Perceptive Pharma Research | Richmond | Texas | 77407 | — |
| Green Mountain Research Institute | Rutland | Vermont | 05701 | — |
| Northwest Clinical Research Center | Bellevue | Washington | 98007 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 87 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05145413, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 5, 2026 · Synced Oct 19, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05145413 live on ClinicalTrials.gov.