SchizophreniaNCT05438160
Exploratory Study of a Digital Therapeutics in People With Schizophrenia
A study testing Clinical Learning Study smartphone app (i.e., the study app) in people with Schizophrenia, run by Click Therapeutics, Inc. at 7 sites in United States.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Clinical Learning Study smartphone app (i.e., the study app)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 7 sitesUnited States
- Study dates
- 31 Mar 2022to 31 Jul 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
- 1. Is willing and able to provide written informed consent to participate in the study, attend study visits, and comply with study-related requirements and assessments.
- 2. Between 18 and 64 years of age at time of informed consent.
- 3. Fluent in written and spoken English, confirmed by ability to read and understand the informed consent form.
- 4. Has a primary diagnosis of schizophrenia using the diagnostic criteria for schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), for at least 1-year prior to screening.
- 5. Is in the stable phase of illness, as assessed by the investigator after review of medical records or documented discussion with the treating physician.
- 6. Has outpatient treatment status at the time of screening, with no inpatient treatment for schizophrenia within 12 weeks prior to screening.
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- 7. Is on a stable dose of antipsychotic medication(s) for at least 12 weeks prior to enrollment (Day 1) as determined by the investigator.
- 8. Has obtained a score of 30 or less on the MAP-SR as assessed at the screening visit.
- 9. Is the sole user, per participant self-report, of an iPhone with an iPhone operating system (iOS) 13 or greater or a smartphone with an Android operating system 9 or greater and is willing to download and use the Study App as required per the protocol.
- 10. Is the owner of, and has regular access to, an email address.
- 11. Has regular access to the internet via cellular data plan and/or wifi.
- 12. 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.
- 13. Understands how to use the Study App during the screening visit as assessed by the investigator during in-clinic Study App installation and activation activities.
Who cannot join
- 1. Is currently treated with more than two antipsychotic medications (including more than two dosage forms).
- 2. Is currently treated with clozapine or haloperidol.
- 3. Has active prominent positive symptoms in the opinion of the investigator that would 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, Tenth Revision (ICD-10) or DSM-5 criteria for diagnoses not under investigation, including schizophreniform, schizoaffective, or psychosis non-specific disorders.
- 6. Has post-traumatic stress disorder (PTSD), bipolar disorder, major depressive disorder, developmental disorders, or any prominent disorder that would interfere with compliance to the protocol, per investigator judgment.
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- 7. Has substance or alcohol use disorder (excluding caffeine and nicotine), that would interfere with compliance to the protocol, per investigator judgment.
- 8. Currently needs or will likely require prohibited concomitant medications and/or therapy during the study, as determined by the investigator.
- 9. Is currently participating in another clinical study (interventional or observational) involving investigational drugs or devices.
- 10. Prior participation in the CT-155-C-001 clinical study.
- 11. Has suicidal ideation or behavior, as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS):
- Participants with a "yes" response to either Items 4 or 5 on the C-SSRS Suicidal Ideation Item within the last 12 weeks prior to screening or at baseline visit.
- Participants with a "yes" response on the C-SSRS Suicidal Behavior Items within the last 26 weeks prior to screening or at baseline visit.
- Participants who, in the opinion of the investigator, present a serious risk of suicide.
- 12. In the judgment of the investigator, any evidence of a clinically significant concomitant disease or any other clinical condition that would jeopardize the participant's safety while participating in the clinical study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
CT-155 Center
Anaheim, California, 92805
CT-155 Center
Hialeah, Florida, 75062
CT-155 Center
Irving, Texas, 75062
CT-155 Center
Lake Mary, Florida, 32746
CT-155 Center
Miami, Florida, 33176
CT-155 Center
Richmond, Texas, 77407
CT-155 Center
Torrance, California, 90502
About this study
Official title: A Multi-center, Exploratory, Single-Arm, 7-week Study to Evaluate the Feasibility and Acceptability of the Medication Tracking and Educational Components of a Clinical Learning Version of CT-155 in People With Schizophrenia
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
Read the detailed description
CT-155 is a novel prescription digital therapeutic (PDT) being developed by Click Therapeutics, Inc. (Click) and Boehringer Ingelheim (BI). CT-155 delivers an interactive, software-based intervention for schizophrenia.
This is a multi-center, exploratory, single-arm study to evaluate the feasibility and acceptability of medication tracking and educational component of a clinical learning study version of CT-155 in adults diagnosed with schizophrenia.
Eligible participants must have a diagnosis of schizophrenia per 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
- Clinical Learning Study smartphone app (i.e., the study app)
- Keywords
- Prescription digital therapeutics, 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.
Clinical Learning Study smartphone app (i.e., the study app)Device
The study app is designed to provide 7-weeks of the medication tracking and educational components in a clinical learning study version of CT-155. This design allows inferences to be made about the usability and acceptability of these components 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 |
|---|---|---|
| Clinical Learning Study version of CT-155 | Other | Single arm acceptability and feasibility of medication tracking and educational components of a clinical learning study version of CT-155 Receives: Device: Clinical Learning Study smartphone app (i.e., the study app) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To explore feasibility and acceptability of the medication tracking and educational components of a clinical learning study version of the CT-155 app
Degree of participant engagement with the study app as measured by participant app use data captured in-app
Measured: Day 49 at the end of treatment period
Secondary outcomes (1)
Change from Week 3 of the Mobile Agnew Relationships Measure
To explore the establishment of a digital working alliance over the course of the Study 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 posted29 Jun 2022
- Study start31 Mar 2022
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Click Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Shaheen Lakhan, MDPhD, FAAN, Study chair, Click Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438160
- Sponsor's protocol ID
- CT-155-C-003
- Status last verified
- Jul 2025
- First submitted
- 18 May 2022
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 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 the Medication Tracking and Educational Components of a Clinical Learning Version of CT-155 in People With Schizophrenia
- ClinicalTrials.gov ID
- NCT05438160
- Acronym / sponsor ID
- CT-155-C-003
- Conditions
- Schizophrenia
- Keywords
- Prescription digital therapeutics, Smartphone app, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Click Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 29 Jun 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) being developed by Click Therapeutics, Inc. (Click) and Boehringer Ingelheim (BI) using an interactive, software-based intervention 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). CT-155 delivers an interactive, software-based intervention for schizophrenia.
This is a multi-center, exploratory, single-arm study to evaluate the feasibility and acceptability of medication tracking and educational component of a clinical learning study version of CT-155 in adults diagnosed with schizophrenia.
Eligible participants must have a diagnosis of schizophrenia per 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
| Arm | Type | Receives |
|---|---|---|
| Clinical Learning Study version of CT-155 | Other | Device: Clinical Learning Study smartphone app (i.e., the study app)Single arm acceptability and feasibility of medication tracking and educational components of a clinical learning study version of CT-155 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 1. Is willing and able to provide written informed consent to participate in the study, attend study visits, and comply with study-related requirements and assessments.
- 2. Between 18 and 64 years of age at time of informed consent.
- 3. Fluent in written and spoken English, confirmed by ability to read and understand the informed consent form.
- 4. Has a primary diagnosis of schizophrenia using the diagnostic criteria for schizophrenia as defined in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), for at least 1-year prior to screening.
- 5. Is in the stable phase of illness, as assessed by the investigator after review of medical records or documented discussion with the treating physician.
Key exclusion criteria (15 listed)
- 1. Is currently treated with more than two antipsychotic medications (including more than two dosage forms).
- 2. Is currently treated with clozapine or haloperidol.
- 3. Has active prominent positive symptoms in the opinion of the investigator that would 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, Tenth Revision (ICD-10) or DSM-5 criteria for diagnoses not under investigation, including schizophreniform, schizoaffective, or psychosis non-specific disorders.
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 |
|---|---|---|
| Clinical Learning Study smartphone app (i.e., the study app)The study app is designed to provide 7-weeks of the medication tracking and educational components in a clinical learning study version of CT-155. This design allows inferences to be made about the usability and acceptability of these components 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 | Clinical Learning Study version of CT-155 |
Primary outcome
To explore feasibility and acceptability of the medication tracking and educational components of a clinical learning study version of the CT-155 app
Time frame: Day 49 at the end of treatment period
Degree of participant engagement with the study app as measured by participant app use data captured in-app
1 secondary outcome
Change from Week 3 of the Mobile Agnew Relationships Measure
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 17 Jul 2025.
- 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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Learning Study smartphone app (i.e., the study app) in people with Schizophrenia, run by Click Therapeutics, Inc. at 7 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 13 inclusion and 15 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 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
To explore feasibility and acceptability of the medication tracking and educational components of a clinical learning study version of the CT-155 app (time frame: Day 49 at the end of treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2025.