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

Sponsor
Click Therapeutics, Inc. (Industry)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05486312
Collaborator
(none)
48
10
1
2.4
4.8
2

Study Details

Study Description

Brief Summary

CT-155 is a novel prescription digital therapeutic (PDT) to treat schizophrenia

Condition or Disease Intervention/Treatment Phase
  • Device: CT-155 smartphone app
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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 schizophreniaThis 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
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 5, 2022
Anticipated Primary Completion Date :
Sep 15, 2022
Anticipated Study Completion Date :
Sep 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Single arm

Single arm acceptability and feasibility of CT-155.

Device: 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.

Outcome Measures

Primary Outcome Measures

  1. 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

  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]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CT-155 Study Center Culver City California United States 90230
2 CT-155 Study Center Garden Grove California United States 92845
3 CT-155 Study Center La Habra California United States 90631
4 CT-155 Study Center San Bernardino California United States 92408
5 CT-155 Study Center Santa Ana California United States 92704
6 CT-155 Study Center Chicago Illinois United States 60611
7 CT-155 Study Center New York New York United States 10032
8 CT-155 study Center Staten Island New York United States 10314
9 CT-155 Study Center Beachwood Ohio United States 44122
10 CT-155 Study Center Oklahoma City Oklahoma United States 73112

Sponsors and Collaborators

  • Click Therapeutics, Inc.

Investigators

  • Study Chair: Shaheen Lakhan, MDPhD, FAAN, Click Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Click Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT05486312
Other Study ID Numbers:
  • CT-155-C-002
First Posted:
Aug 3, 2022
Last Update Posted:
Aug 22, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Click Therapeutics, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 22, 2022