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This study is open to people aged 18 years or older with schizophrenia. People can join the study if they are willing to use a smartphone app called CT-155. This app is being developed to help people with schizophrenia manage their negative symptoms.
The purpose of this study is to gather new information on CT-155. Researchers want to see how well it works, how well participants use the study app, and how it affects the use of health care services.
Participants use the app for 16 weeks. They may continue using it for another 16 weeks. During the study, participants continue with their normal treatment for schizophrenia. Participants are in the study for about a year. During this time, they visit the study site every 2 months.
During this study, doctors regularly check participants' schizophrenia symptoms and overall quality of life. Researchers may also compare the healthcare data of study participants with a similar group of people with schizophrenia who are not part of the study. The doctors also regularly check participants' health and take note of any unwanted effects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-155 treatment arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital therapeutic (CT-155) | Device | Digital therapeutic (CT-155) - in the form of a smartphone app |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess the change from Baseline to Week 16 in negative symptoms severity, as assessed by the CGI-SCH negative symptoms item 2 among patients with schizophrenia using the investigational CT-155 Digital Therapeutic (DTx) | The Clinical Global Impression - Schizophrenia (CGI-SCH) contains 2 categories: severity of illness and degree of change. The severity of illness category evaluates the situation during the week prior to the assessment, while the degree of change category evaluates the change from the previous evaluation. Each category contains 5 different ratings (positive, negative, depressive, cognitive and global) that are evaluated using a seven-point ordinal scale (1 [Normal, not ill] - 7 [Among the most severely ill]) with higher ratings indicating more severe illness (severity of illness) or worsening of symptoms (degree of change). | up to 16 weeks |
| To assess the change from Baseline to Week 16 in experiential negative symptoms (ENS), as assessed by the Motivation and Pleasure Scale Self-Report (MAP-SR) among patients with schizophrenia using the investigational CT-155 DTx | The MAP-SR is an 15-item self-report version of the Clinical Assessment Interview for Negative Symptoms Motivation and Pleasure subscale. Six items evaluate consummatory and anticipatory pleasure related to social and recreational or work domains; 3 items evaluate feelings and motivations to be around family, romantic partners, and friends; 6 items evaluate motivation and effort to engage in activities. All items are rated on a 5-point Likert scale (0 [not at all] - 4 [extreme pleasure]) with lower scores representing greater pathology. | up to 16 weeks |
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Inclusion Criteria
Further inclusion criteria apply.
Exclusion Criteria
Has a score of ≥3 (mildly ill) for CGI-SCH positive symptoms (item #1) at Screening.
Has active substance use disorder of any severity in the last 3 months, other than caffeine and nicotine. Patients are excluded if they fulfill criteria for moderate or severe substance use disorder for cannabis. Only mild substance use disorder for cannabis is allowed if considered by investigator to not impact ability of the patient to participate in the study.
Has suicidal ideation or behavior, as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS):
Patients who, in the opinion of the investigator, present a risk of suicide.
Is currently enrolled or has participated in the last 3 months (12 weeks) in a mental health related clinical study (interventional or observational).
Has participated in previous studies of CT-155 or CT-156.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Valley Behavioral Med Center | Imperial | California | 92251 | United States | ||
| University of California San Diego |
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| Label | URL |
|---|---|
| Related Info | View source |
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Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
For study documents - upon signing of a "Document Sharing Agreement". For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
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| La Jolla |
| California |
| 92093 |
| United States |
| North Country Clinical Research Inc | Oceanside | California | 92054 | United States |
| ATP Clinical Research, Inc. | Orange | California | 92866 | United States |
| NRC Research Institute | Orange | California | 92868 | United States |
| Stanford University Medical Center | Stanford | California | 94304 | United States |
| Collaborative Neuroscience Research | Torrance | California | 90504 | United States |
| CT Clinical Research | Cromwell | Connecticut | 06416 | United States |
| Galiz Research | Hialeah | Florida | 33106 | United States |
| New Life Medical Research Center, Inc. | Hialeah | Florida | 88012 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Global Life Research Network | Miami | Florida | 33155 | United States |
| Interventional Psychiatry of Tampa Bay | Tampa | Florida | 33629 | United States |
| Health Synergy Clinical Research, LLC | West Palm Beach | Florida | 33407 | United States |
| Emory University | Atlanta | Georgia | 30303 | United States |
| Sheppard Pratt Physicians's Practice Association, Inc. | Baltimore | Maryland | 21204 | United States |
| Center for Behavioral Health, LLC | Gaithersburg | Maryland | 20877 | United States |
| Boston Neurobehavioral Associates | Brookline | Massachusetts | 02446 | United States |
| University of Massachusetts - Worcester | Worcester | Massachusetts | 01655 | United States |
| Western Michigan University | Kalamazoo | Michigan | 49048 | United States |
| St. Charles Psychiatric Associates & Midwest Research Group | Saint Charles | Missouri | 63304 | United States |
| IMA Clinical Research Las Vegas | Las Vegas | Nevada | 89102 | United States |
| Neurobehavioral Research, Inc. | Cedarhurst | New York | 11516 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10314 | United States |
| Atrium Health | Charlotte | North Carolina | 28211 | United States |
| Rivus Wellness and Research Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Psychiatric Consultants,PC | Franklin | Tennessee | 37067 | United States |
| Beaumont Psychiatry Clinic | Beaumont | Texas | 77706 | United States |
| Red Oak Psychiatry Associates, PA | Houston | Texas | 77090 | United States |
| SMS Clinical Research | Mesquite | Texas | 75149 | United States |
| Salem VA Medical Center | Salem | Virginia | 24153 | United States |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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