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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
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An exploratory, double-arm, 8-week study to explore the feasibility and acceptability of abbreviated treatment with CT-156 for people with Schizophrenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-156 | Active Comparator | Study App investigational treatment for adult patients diagnosed with Schizophrenia. |
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| CT-156 + UXR | Experimental | Study app investigational treatment for adult patients diagnosed with schizophrenia with up to five in-patient visits with three interviews for UXR (user experience research) arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-156 | Device | CT-156 is a digital therapeutic (DTx) under development to treat patients 18 years of age and older with a diagnosis of schizophrenia under standard of care therapy who are on antipsychotic medication and not currently experiencing acute hallucinations or delusions. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Days Used | Number of days the Study App is opened out of total days of treatment | Day 0 to Week 8 |
| Number of Times Study App is Opened | Number of times the Study App is opened during the treatment period | Day 0 to Week 8 |
| Number of Medication Check-ins Completed | Number of medication check-ins completed during the treatment period out of total assigned | Day 0 to Week 8 |
| Number of Assigned Tasks Completed | Number of assigned tasks completed during the treatment period | Day 0 to Week 8 |
| Average Duration of Use | Average duration of each App-use session | Day 0 to Week 8 |
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Inclusion Criteria:
Exclusion Criteria:
Has positive symptoms of schizophrenia that, in the opinion of the investigator, would preclude effective engagement in the treatment to improve functional impairment.
Is currently receiving or has received concomitant therapy, defined as individual or group-based structured treatment (e.g., Cognitive Behavioral Therapy, Social Skills Training, Motivational Interviewing, or Vocational/Occupational Therapy), within 3 months (13 weeks) prior to screening per investigator assessment.
Is currently treated with more than 2 antipsychotic medications (including more than 2 dosage forms).
Meets ICD-11 or DSM-5 criteria for diagnoses not under investigation that will impact compliance to the protocol, including schizophreniform, schizoaffective, or psychosis non-specific disorders (post-traumatic stress disorder [PTSD], bipolar disorder, major depressive disorder, developmental disorders).
Meets ICD-11 or DSM-5 criteria for a current episode of depression, mania or hypomania.
Meets ICD-11 or DSM-5 criteria for a current substance or alcohol use disorder (excluding caffeine and nicotine) that would interfere with compliance to the protocol, per investigator judgment. Diagnoses classified as in sustained remission are permitted.
In the investigator's opinion, currently needs or will likely require prohibited concomitant medications and/or therapy during the study.
Is at moderate to high risk for suicide, defined by any of the following:
Has participated in another clinical study (interventional or observational) in the last 13 weeks (3 months).
Has previously participated in any of the following studies: CT-155-C-001, CT-155-C-002, CT-155-C-003, CT-155-P-00x, CT-155-A-001, CT-155-R- 001, CT-156-D-001, CT-156-C-001, CT-156-P-00x.
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| Name | Affiliation | Role |
|---|---|---|
| Shaheen Lakhan | Click Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Click Therapeutics | New York | New York | 10013 | United States |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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