SchizophreniaNCT05486312
7-week Study With CT-155 in People With Schizophrenia
A study testing CT-155 smartphone app in people with Schizophrenia, run by Click Therapeutics, Inc. at 10 sites in United States.
Trial summary
CT-155 is a novel prescription digital therapeutic (PDT) to treat schizophrenia Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- CT-155 smartphone app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 10 sitesUnited States
- Study dates
- 5 Jul 2022to 12 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
CT-155 Study Center
Beachwood, Ohio, 44122
CT-155 Study Center
Chicago, Illinois, 60611
CT-155 Study Center
Culver City, California, 90230
CT-155 Study Center
Garden Grove, California, 92845
CT-155 Study Center
La Habra, California, 90631
CT-155 Study Center
New York, New York, 10032
CT-155 Study Center
Oklahoma City, Oklahoma, 73112
CT-155 Study Center
San Bernardino, California, 92408
CT-155 Study Center
Santa Ana, California, 92704
CT-155 study Center
Staten Island, New York, 10314
About this study
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
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.
- Conditions
- Schizophrenia
- Being tested
- CT-155 smartphone app
- Keywords
- Prescription digital therapeutic (PDT), Software-as-a Medical Device (SaMD), Smartphone app, Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-155 smartphone appDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Single arm acceptability and feasibility of CT-155. Receives: Device: CT-155 smartphone app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Change from Week 3 to Week 7 of the Mobile Agnew Relationships Measure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start5 Jul 2022
- Primary completion22 Sep 2022
- Study completion12 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- 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 schizophrenia
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Click Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shaheen Lakhan, MDPhD, FAAN, Study chair, Click Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486312
- Sponsor's protocol ID
- CT-155-C-002
- Status last verified
- May 2025
- First submitted
- 1 Aug 2022
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 39869902
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05486312
- Acronym / sponsor ID
- CT-155-C-002
- Conditions
- Schizophrenia
- Keywords
- Prescription digital therapeutic (PDT), Software-as-a Medical Device (SaMD), Smartphone app, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Click Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 12 Dec 2022 (actual)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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 schizophrenia
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Device: CT-155 smartphone appSingle arm acceptability and feasibility of CT-155. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-155 smartphone appThe 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. | Device | Single arm |
Primary outcome
Feasibility and acceptability with the study app as measured by Mobile App Rating Scale (MARS) at week 7
Time frame: 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
1 secondary outcome
Change in strength of digital working alliance from Week 3 to Week 7 as assessed by the Mobile Agnew Relationships Measure (mARM)
Time frame: Change from Week 3 to Week 7 of the Mobile Agnew Relationships Measure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Derived from this study: PubMed 39869902Snipes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shaheen Lakhan, MDPhD, FAAN study chair
Click Therapeutics
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-155 smartphone app in people with Schizophrenia, run by Click Therapeutics, Inc. at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and acceptability with the study app as measured by Mobile App Rating Scale (MARS) at week 7 (time frame: MARS scale on Week 7 at the end of the treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05486312, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.