Clinical trial NCT05438160: Exploratory Study of the Digital Therapeutics CT-155 in the Treatment of People With Schizophrenia
Official title: A Multi-center, Exploratory, Single-Arm, 7-week Study to Evaluate the Feasibility and Acceptability of the Treatment Monitoring and Educational Components of CT-155 in People With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Prescription digital therapeutics
Smartphone app
Schizophrenia
Lead sponsor: Click Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Boehringer Ingelheim
First posted: 2022-06-29
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: To explore feasibility and acceptability of the treatment monitoring and educational components of CT-155 app
timeFrame: Day 49 at the end of treatment period
Secondary outcomes:
measure: Change from Week 3 of the Mobile Agnew Relationships Measure
timeFrame: Change from Week 3 to Week 7 of the Mobile Agnew Relationships Measure
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: CT-155 Center
state: California
city: Torrance
country: United States
facility: CT-155 Center
state: California
city: Hialeah
country: United States
facility: CT-155 Center
state: Florida
city: Lake Mary
country: United States
facility: CT-155 Center
state: Florida
city: Miami
country: United States
facility: CT-155 Center
state: Florida
city: Irving
country: United States
facility: CT-155 Center
state: Texas
city: Richmond
country: United States
facility: CT-155 Center
state: Texas
Study officials:
affiliation: Click Therapeutics
name: Shaheen Lakhan, MDPhD, FAAN
role: STUDY_CHAIR
References: