7-week Study With CT-155 in People With Schizophrenia
A Multi-center, Exploratory, Single-Arm, 7-week Study to Evaluate the Feasibility and Acceptability of Treatment With CT-155 in People With Schizophrenia
1 other identifier
interventional
72
1 country
10
Brief Summary
CT-155 is a novel prescription digital therapeutic (PDT) to treat schizophrenia
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable schizophrenia
Started Jul 2022
Shorter than P25 for not_applicable schizophrenia
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 5, 2022
CompletedFirst Submitted
Initial submission to the registry
August 1, 2022
CompletedFirst Posted
Study publicly available on registry
August 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2022
CompletedMay 15, 2025
May 1, 2025
3 months
August 1, 2022
May 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasibility and acceptability with the study app as measured by Mobile App Rating Scale (MARS) at week 7
Participants ratings of Study App quality and satisfaction as measured by the Mobile App Rating Scale (MARS) at Week 7 The MARS is a validated 23-items rated on a 5-point anchored scale 1 being the lowest and 5 the highest
MARS scale on Week 7 at the end of the treatment period
Secondary Outcomes (1)
Change in strength of digital working alliance from Week 3 to Week 7 as assessed by the Mobile Agnew Relationships Measure (mARM)
Change from Week 3 to Week 7 of the Mobile Agnew Relationships Measure
Study Arms (1)
Single arm
EXPERIMENTALSingle arm acceptability and feasibility of CT-155.
Interventions
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
You may qualify if:
- Has outpatient treatment status of schizophrenia.
- Is on a stable dose of antipsychotic medication(s)
- 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.
- Is the owner of, and has regular access to, an email address.
- Has regular access to the internet via cellular data plan and/or wifi.
- Willing and able to receive SMS text messages on their smartphone and email messages, and understand how to use the downloaded Study App.
- 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
You may not qualify if:
- Is currently treated with more than two antipsychotic medications.
- Is currently treated with clozapine or haloperidol.
- Has active prominent positive symptoms to preclude effective engagement in treatment for negative symptoms.
- Is currently receiving or has received psychotherapy within 12 weeks prior to screening.
- Meets either the International Classification of Diseases (ICD-10) or DSM-5 criteria for diagnoses not under investigation.
- Has post-traumatic stress disorder (PTSD), bipolar disorder, major depressive disorder, developmental disorders, or any prominent disorder.
- Has substance or alcohol use disorder.
- Currently needs or will likely require prohibited concomitant medications.
- Is currently participating in another clinical study.
- Prior participation in the CT-155-C-001 clinical study.
- Has suicidal ideation or behavior.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
CT-155 Study Center
Culver City, California, 90230, United States
CT-155 Study Center
Garden Grove, California, 92845, United States
CT-155 Study Center
La Habra, California, 90631, United States
CT-155 Study Center
San Bernardino, California, 92408, United States
CT-155 Study Center
Santa Ana, California, 92704, United States
CT-155 Study Center
Chicago, Illinois, 60611, United States
CT-155 Study Center
New York, New York, 10032, United States
CT-155 study Center
Staten Island, New York, 10314, United States
CT-155 Study Center
Beachwood, Ohio, 44122, United States
CT-155 Study Center
Oklahoma City, Oklahoma, 73112, United States
Related Publications (1)
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.
PMID: 39869902DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Shaheen Lakhan, MDPhD, FAAN
Click Therapeutics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2022
First Posted
August 3, 2022
Study Start
July 5, 2022
Primary Completion
September 22, 2022
Study Completion
December 12, 2022
Last Updated
May 15, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share