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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

CT-155-C-003

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18 to 64 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 3 years ago

What is this trial about?

CT-155 is a novel prescription digital therapeutic (PDT) being developed by Click Therapeutics, Inc. (Click) and Boehringer Ingelheim (BI) using an interactive, software-based intervention to treat schizophrenia

What are the participation requirements?

Yes

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

No

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.

Locations

Location

Status