7-week Study With CT-155 in People With Schizophrenia

Not Applicable

Completed

• Conditions: Schizophrenia
• Interventions: Device: CT-155 smartphone app

• Registration Number: NCT05486312
• Lead Sponsor: Click Therapeutics, Inc.

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.

Study Timeline

• Study Start: 2022-07-05
• Study First Submitted: 2022-08-01
• Study First Submitted QC: 2022-08-01
• Study First Posted: 2022-08-03
• Primary Completion: 2022-09-22
• Study Completion: 2022-12-12
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-28
• Last Update Posted: 2023-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single arm	CT-155 smartphone app	Single arm acceptability and feasibility of CT-155.

Primary Outcome Measures

Name	Time	Method
Feasibility and acceptability with the study app as measured by Mobile App Rating Scale (MARS) at week 7	MARS scale on Week 7 at the end of the treatment period	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

Secondary Outcome Measures

Name	Time	Method
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	To explore the establishment of a digital working alliance as assessed by the change from Week 3 to Week 7 of the Mobile Agnew Relationships Measure. The Mobile Agnew Relationships Measures is on a 7-item scale that ranges from "Strongly Disagree" as scale 1 to "Strongly Agree" as scale 7.

Trial Locations

Locations (2)

CT-155 Study Center; 🇺🇸 Oklahoma City, Oklahoma, United States

CT-155 study Center; 🇺🇸 Staten Island, New York, United States