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The purpose of this study is to understand treatment preference and satisfaction among adults with schizophrenia in the United States who are prescribed xanomeline and trospium chloride (X/T) therapy
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving xanomeline and trospium chloride (X/T) therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| xanomeline and trospium chloride (X/T) therapy | Drug | According to the product label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant medication preference as assessed by the Preference of Medication (POM) questionnaire | Month 1, Month 3, Month 6 | |
| Participant treatment satisfaction as assessed by the Medication Satisfaction Questionnaire (MSQ) | Baseline, Month 1, Month 3, Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment titration plan as described by the treating clinician | Baseline, Month 1, Month 3, Month 6 | |
| Treatment switch plan as described by the treating physician | Baseline, Month 1, Month 3, Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include adults diagnosed with schizophrenia who initiate treatment with xanomeline and trospium chloride (XT) in the US.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0009 | Not yet recruiting | Orange | California | 92868 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| Treatment dose prescribed | Baseline, Month 1, Month 3, Month 6 |
| Concomitant medication prescribed | Baseline, Month 1, Month 3, Month 6 |
| Number of participants who are prescribed a treatment dose change | Month 1, Month 3, Month 6 |
| Reasons for treatment discontinuation | Month 1, Month 3, Month 6 |
| Participant baseline clinical characteristics | Baseline |
| Participant baseline demographics | Baseline |
| Lumos Clinical Research Center | Recruiting | San Jose | California | 95124 | United States |
|
| Local Institution - 0003 | Not yet recruiting | Evanston | Illinois | 60201 | United States |
|
| The Johns Hopkins Hospital | Recruiting | Baltimore | Maryland | 21287 | United States |
|
| Local Institution - 0017 | Not yet recruiting | Bel Air | Maryland | 21015 | United States |
|
| Local Institution - 0004 | Withdrawn | Catonsville | Maryland | 21228 | United States |
| Local Institution - 0008 | Not yet recruiting | Belmont | Massachusetts | 02478-1064 | United States |
|
| Local Institution - 0002 | Not yet recruiting | Boston | Massachusetts | 02118 | United States |
|
| Mayflower Clinical | Recruiting | South Dartmouth | Massachusetts | 02747 | United States |
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| Omaha Insomnia and Psychiatric Services | Recruiting | Omaha | Nebraska | 68144 | United States |
|
| Hackensack Meridian Health - Carrier Clinic | Recruiting | Belle Mead | New Jersey | 08502 | United States |
|
| Radial - Manhattan | Recruiting | New York | New York | 10018 | United States |
|
| New Dawn Psychiatric Services, PLLC | Recruiting | Kinston | North Carolina | 28501 | United States |
|
| New Dimension Group | Recruiting | Rose Hill | North Carolina | 28458 | United States |
|
| Westlake Brain Health | Recruiting | Westlake | Ohio | 44145 | United States |
|
| Continuum Health Providers | Recruiting | Fort Mill | South Carolina | 29708 | United States |
|
| Haracec Clinical Research | Recruiting | El Paso | Texas | 79902 | United States |
|
| C-Trilogy Outreach | Recruiting | Longview | Texas | 75601 | United States |
|
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C075257 | xanomeline |
| C003330 | trospium chloride |
| D013812 | Therapeutics |
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