Exploratory Study of the Digital Therapeutics CT-155 in the Treatment of People With Schizophrenia

Click Therapeutics

Status: Completed

Conditions: Schizophrenia

Treatments: Device: Digital therapeutics app CT-155

Study type: Interventional

Funder types: Industry

Identifiers

NCT05438160

CT-155-C-003

Details and patient eligibility

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

Full description

CT-155 is a novel prescription digital therapeutic (PDT) being developed by Click Therapeutics, Inc. (Click) and Boehringer Ingelheim (BI). CT-155 delivers an interactive, software-based intervention for schizophrenia. During a PDT development lifecycle, iterations of the PDT may be scientifically evaluated in a user population that is clinically representative of the intended patient population. Data generated via this evaluation can be used to drive the modification and optimization of specific therapeutic components contained within a given PDT.

Enrollment: 48 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Schizophrenia treated with digital therapeutics app CT-155

Other group

Description:

Single group of People with Schizophrenia to be treated with digital therapeutics app CT-155

Treatment:

Device: Digital therapeutics app CT-155