Clinical trial NCT05486312: 7-week Study With CT-155 in People With Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Prescription digital therapeutic (PDT)
Software-as-a Medical Device (SaMD)
Smartphone app
Schizophrenia
Lead sponsor: Click Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-08-03
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a multi-center, exploratory, single-arm study to evaluate the overall effects of use of an abbreviated version of CT-155 in adults diagnosed with schizophrenia
Primary purpose: DEVICE_FEASIBILITY

Brief summary: CT-155 is a novel prescription digital therapeutic (PDT) 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) using an interactive, software-based intervention to treat schizophrenia.

This is a multi-center, exploratory, single-arm study to evaluate the feasibility and acceptability of treatment with an abbreviated version of CT-155 in adults diagnosed with schizophrenia. Eligible participants must have a diagnosis of schizophrenia per the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5).

Participants that meet eligibility criteria will be enrolled in the study on Day 1. The study consists of an up to 7-day screening period, a 49-day engagement period, and an up to 7-day follow-up period.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility and acceptability with the study app as measured by Mobile App Rating Scale (MARS) at week 7
timeFrame: MARS scale on Week 7 at the end of the treatment period
Secondary outcomes:
measure: Change in strength of digital working alliance from Week 3 to Week 7 as assessed by the Mobile Agnew Relationships Measure (mARM)
timeFrame: Change from Week 3 to Week 7 of the Mobile Agnew Relationships Measure
Other outcomes:
Locations:
city: Culver City
country: United States
facility: CT-155 Study Center
state: California
city: Garden Grove
country: United States
facility: CT-155 Study Center
state: California
city: La Habra
country: United States
facility: CT-155 Study Center
state: California
city: San Bernardino
country: United States
facility: CT-155 Study Center
state: California
city: Santa Ana
country: United States
facility: CT-155 Study Center
state: California
city: Chicago
country: United States
facility: CT-155 Study Center
state: Illinois
city: New York
country: United States
facility: CT-155 Study Center
state: New York
city: Staten Island
country: United States
facility: CT-155 study Center
state: New York
city: Beachwood
country: United States
facility: CT-155 Study Center
state: Ohio
city: Oklahoma City
country: United States
facility: CT-155 Study Center
state: Oklahoma
Study officials:
affiliation: Click Therapeutics
name: Shaheen Lakhan, MDPhD, FAAN
role: STUDY_CHAIR
References: