Schizophrenia Clinical Trial
Official title:
A Multi-center, Exploratory, Single-Arm, 7-week Study to Evaluate the Feasibility and Acceptability of Treatment With CT-155 in People With Schizophrenia
Verified date | September 2023 |
Source | Click Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
CT-155 is a novel prescription digital therapeutic (PDT) to treat schizophrenia
Status | Completed |
Enrollment | 50 |
Est. completion date | December 12, 2022 |
Est. primary completion date | September 22, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | Inclusion Criteria: 1. Has outpatient treatment status of schizophrenia. 2. Is on a stable dose of antipsychotic medication(s) 3. Is the solo user of an iPhone with iPhone operating system (iOS)13 or greater capabilities or a smart phone with an Android operating system (OS) 9 or greater capabilities. 4. Is the owner of, and has regular access to, an email address. 5. Has regular access to the internet via cellular data plan and/or wifi. 6. Willing and able to receive SMS text messages on their smartphone and email messages, and understand how to use the downloaded Study App. 7. Has stable housing and has remained at the same residence for at least 12 weeks prior to screening, with no anticipated housing changes during the duration of the study Exclusion Criteria: 1. Is currently treated with more than two antipsychotic medications. 2. Is currently treated with clozapine or haloperidol. 3. Has active prominent positive symptoms to preclude effective engagement in treatment for negative symptoms. 4. Is currently receiving or has received psychotherapy within 12 weeks prior to screening. 5. Meets either the International Classification of Diseases (ICD-10) or DSM-5 criteria for diagnoses not under investigation. 6. Has post-traumatic stress disorder (PTSD), bipolar disorder, major depressive disorder, developmental disorders, or any prominent disorder. 7. Has substance or alcohol use disorder. 8. Currently needs or will likely require prohibited concomitant medications. 9. Is currently participating in another clinical study. 10. Prior participation in the CT-155-C-001 clinical study. 11. Has suicidal ideation or behavior. |
Country | Name | City | State |
---|---|---|---|
United States | CT-155 Study Center | Beachwood | Ohio |
United States | CT-155 Study Center | Chicago | Illinois |
United States | CT-155 Study Center | Culver City | California |
United States | CT-155 Study Center | Garden Grove | California |
United States | CT-155 Study Center | La Habra | California |
United States | CT-155 Study Center | New York | New York |
United States | CT-155 Study Center | Oklahoma City | Oklahoma |
United States | CT-155 Study Center | San Bernardino | California |
United States | CT-155 Study Center | Santa Ana | California |
United States | CT-155 study Center | Staten Island | New York |
Lead Sponsor | Collaborator |
---|---|
Click Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Feasibility and acceptability with the study app as measured by Mobile App Rating Scale (MARS) at week 7 | Participants ratings of Study App quality and satisfaction as measured by the Mobile App Rating Scale (MARS) at Week 7 The MARS is a validated 23-items rated on a 5-point anchored scale 1 being the lowest and 5 the highest |
MARS scale on Week 7 at the end of the treatment period | |
Secondary | Change in strength of digital working alliance from Week 3 to Week 7 as assessed by the Mobile Agnew Relationships Measure (mARM) | To explore the establishment of a digital working alliance as assessed by the change from Week 3 to Week 7 of the Mobile Agnew Relationships Measure. The Mobile Agnew Relationships Measures is on a 7-item scale that ranges from "Strongly Disagree" as scale 1 to "Strongly Agree" as scale 7. | Change from Week 3 to Week 7 of the Mobile Agnew Relationships Measure |
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