Exploratory Study of the Digital Therapeutics CT-155 in the Treatment of People With Schizophrenia
Sponsored by Click Therapeutics, Inc.
About this trial
Last updated 3 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended 3 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
1. Has outpatient treatment status of schizophrenia. -
2. Is on a stable dose of antipsychotic medication(s) -
3. Is the sole 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.