Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
72 participants
INTERVENTIONAL
2022-07-05
2022-12-12
Brief Summary
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Exploratory Study of a Digital Therapeutics in People With Schizophrenia
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A Prospective Cohort Study to Assess Clinical Effectiveness of an Investigational Digital Therapeutic (CT-155) in Patients With Experiential Negative Symptoms of Schizophrenia
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Single arm
Single arm acceptability and feasibility of CT-155.
CT-155 smartphone app
The CT-155 study app is designed to provide treatment monitoring and educational components of a full treatment cycle with CT-155. This design allows inferences to be made about the usability and acceptability of CT-155. Eligible participants will be enrolled during an in-person clinic visit on Day 1. Participants will then be directed to access the study app and perform tasks each day for the 49-day engagement period.
Interventions
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CT-155 smartphone app
The CT-155 study app is designed to provide treatment monitoring and educational components of a full treatment cycle with CT-155. This design allows inferences to be made about the usability and acceptability of CT-155. Eligible participants will be enrolled during an in-person clinic visit on Day 1. Participants will then be directed to access the study app and perform tasks each day for the 49-day engagement period.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
64 Years
ALL
No
Sponsors
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Click Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Shaheen Lakhan, MDPhD, FAAN
Role: STUDY_CHAIR
Click Therapeutics
Locations
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CT-155 Study Center
Culver City, California, United States
CT-155 Study Center
Garden Grove, California, United States
CT-155 Study Center
La Habra, California, United States
CT-155 Study Center
San Bernardino, California, United States
CT-155 Study Center
Santa Ana, California, United States
CT-155 Study Center
Chicago, Illinois, United States
CT-155 Study Center
New York, New York, United States
CT-155 study Center
Staten Island, New York, United States
CT-155 Study Center
Beachwood, Ohio, United States
CT-155 Study Center
Oklahoma City, Oklahoma, United States
Countries
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References
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Snipes C, Dorner-Ciossek C, Hare BD, Besedina O, Campellone T, Petrova M, Lakhan SE, Pratap A. Establishment and Maintenance of a Digital Therapeutic Alliance in People Living With Negative Symptoms of Schizophrenia: Two Exploratory Single-Arm Studies. JMIR Ment Health. 2025 Jan 27;12:e64959. doi: 10.2196/64959.
Other Identifiers
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CT-155-C-002
Identifier Type: -
Identifier Source: org_study_id
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