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CompletedNCT05486312Updated May 15, 2025

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

An interventional study of CT-155 smartphone app in Schizophrenia, sponsored by Click Therapeutics, Inc.. Completed at 10 sites in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-05-15.

Sponsored by Click Therapeutics, Inc. · Not applicable, Interventional, and Device feasibility

From the registry’s dates

  • Primary completion was Sep 2022, 4 years ago, and no results have been posted to the registry.
Phase
Not applicable
Study type
Interventional
Enrollment
72
Allocation
Not applicable
Ages
18 Years to 64 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Schizophrenia

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Keywords

  • Prescription digital therapeutic (PDT)
  • Software-as-a Medical Device (SaMD)
  • Smartphone app
  • Schizophrenia
03

In context

Schizophrenia

3,472 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 72 is close to the median of 70 across 2,873 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Click Therapeutics, Inc. is the lead sponsor of 16 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
72 participants (actual)

Study arms

  • Experimental
    Single arm

    Single arm acceptability and feasibility of CT-155.

    Device: CT-155 smartphone app

Interventions

  • DeviceCT-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.

06

What researchers measure

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

    Time frame: 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)

    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.

    Time frame: Change from Week 3 to Week 7 of the Mobile Agnew Relationships Measure

07

Study locations

10 sites
  • 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
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05486312
Lead sponsor
Click Therapeutics, Inc.
Responsible party
Sponsor
First posted
Aug 3, 2022
Start date
Jul 5, 2022
Primary completion
Sep 22, 2022
Completion
Dec 12, 2022
Last update
May 15, 2025

Study contacts

Shaheen Lakhan, MDPhD, FAAN
study chair · Click Therapeutics

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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