SchizophreniaNCT06486948
An Exploratory, Double-arm, 8-week Study to Explore the Feasibility and Acceptability of Abbreviated Treatment with CT-156 in People with Schizophrenia.
A study testing CT-156 in people with Schizophrenia, run by Click Therapeutics, Inc. at 1 site in United States.
Trial summary
An exploratory, double-arm, 8-week study to explore the feasibility and acceptability of abbreviated treatment with CT-156 for people with Schizophrenia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- CT-156
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2024to 9 Aug 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent to participate in the study, attend study visits, and comply with study-related requirements and assessments.
- Is at least 18 years of age at the time of informed consent.
- Fluent in written and spoken English, confirmed by ability to read and understand the informed consent form.
- Lives in the United States.
- Meets diagnostic criteria for a primary diagnosis of schizophrenia as defined in the ICD-11 or DSM-5 for at least 6 months prior to screening.
- Has outpatient treatment status at the time of screening, with no psychiatric inpatient hospitalization within 13 weeks (3 months) prior to screening.
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- Is currently prescribed at least one typical and/or atypical antipsychotic medication and has been on the same antipsychotic medication(s) for at least 13 weeks (3 months) prior to enrollment (Day 1). Dose adjustments are permitted during the study as outlined in the respective package insert(s).
- Has an average domain score ≥2 in at least 2 domains of Understanding and Communicating, Getting Along with People, Life Activities - Household, or Participation in Society on the WHO-DAS 2.0.
- Participant is the only user of an iPhone with iPhone operating system (iOS) version 15 or later or a smartphone with an Android operating system (OS) version 12 or later and agrees to download and use the digital mobile application as required by the protocol.
- Is willing and able to receive short message service (SMS) text messages and push messages on their smartphone.
- Is the owner of or has regular access to an email address.
- Has regular access to the internet via cellular data plan and/or WiFi.
- Has stable housing and has remained at the same residence for at least 13 weeks (3 months) prior to screening and does not anticipate any housing changes for the duration of the study.
- Understands the use of Study App during the Screening Period and at the Baseline Visit, per investigator judgment.
Who cannot join
- Has positive symptoms of schizophrenia that, in the opinion of the investigator, would preclude effective engagement in the treatment to improve functional impairment.
- Is currently receiving or has received concomitant therapy, defined as individual or group-based structured treatment (e.g., Cognitive Behavioral Therapy, Social Skills Training, Motivational Interviewing, or Vocational/Occupational Therapy), within 3 months (13 weeks) prior to screening per investigator assessment.
- Is currently treated with more than 2 antipsychotic medications (including more than 2 dosage forms).
- Meets ICD-11 or DSM-5 criteria for diagnoses not under investigation that will impact compliance to the protocol, including schizophreniform, schizoaffective, or psychosis non-specific disorders (post-traumatic stress disorder [PTSD], bipolar disorder, major depressive disorder, developmental disorders).
- Meets ICD-11 or DSM-5 criteria for a current episode of depression, mania or hypomania.
- Meets ICD-11 or DSM-5 criteria for a current substance or alcohol use disorder (excluding caffeine and nicotine) that would interfere with compliance to the protocol, per investigator judgment. Diagnoses classified as in sustained remission are permitted.
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- In the investigator's opinion, currently needs or will likely require prohibited concomitant medications and/or therapy during the study.
- Is at moderate to high risk for suicide, defined by any of the following:
- A "yes" response to either item 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Items within the last 13 weeks (3 months) prior to screening or at Baseline (Day 1)
- A "yes" response on the C-SSRS Suicidal Behavior Items within the last 26 weeks (6 months) prior to screening or at Baseline (Day 1)
- In the opinion of the investigator, presents a serious risk of suicide
- Has participated in another clinical study (interventional or observational) in the last 13 weeks (3 months).
- Has previously participated in any of the following studies: CT-155-C-001, CT-155-C-002, CT-155-C-003, CT-155-P-00x, CT-155-A-001, CT-155-R- 001, CT-156-D-001, CT-156-C-001, CT-156-P-00x.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Exploratory, Randomized, Double-Arm, 8-week Study to Evaluate the Feasibility and Acceptability of an Abbreviated Treatment with CT-156 in People with Schizophrenia
An exploratory, double-arm, 8-week study to explore the feasibility and acceptability of abbreviated treatment with CT-156 for people with Schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- CT-156
- Keywords
- Schizophrenia, Software as a Medical Device (SaMD), Smartphone app
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-156Device
CT-156 is a digital therapeutic (DTx) under development to treat patients 18 years of age and older with a diagnosis of schizophrenia under standard of care therapy who are on antipsychotic medication and not currently experiencing acute hallucinations or delusions.
| Study group | Role | What they receive |
|---|---|---|
| CT-156 | Active comparator | Study App investigational treatment for adult patients diagnosed with Schizophrenia. Receives: Device: CT-156 |
| CT-156 + UXR | Experimental | Study app investigational treatment for adult patients diagnosed with schizophrenia with up to five in-patient visits with three interviews for UXR (user experience research) arm. Receives: Device: CT-156 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days Used
Number of days the Study App is opened out of total days of treatment
Measured: Day 0 to Week 8
Number of Times Study App is Opened
Number of times the Study App is opened during the treatment period
Measured: Day 0 to Week 8
Number of Medication Check-ins Completed
Number of medication check-ins completed during the treatment period out of total assigned
Measured: Day 0 to Week 8
Number of Assigned Tasks Completed
Number of assigned tasks completed during the treatment period
Measured: Day 0 to Week 8
Average Duration of Use
Average duration of each App-use session
Measured: Day 0 to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2024
- Study start6 May 2024
- Primary completion9 Aug 2024
- Study completion9 Aug 2024
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 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, Study director, Click Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06486948
- Sponsor's protocol ID
- CT-156-C-002
- Status last verified
- Jan 2025
- First submitted
- 27 Jun 2024
- Last updated
- 9 Jan 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 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Exploratory, Randomized, Double-Arm, 8-week Study to Evaluate the Feasibility and Acceptability of an Abbreviated Treatment with CT-156 in People with Schizophrenia
- ClinicalTrials.gov ID
- NCT06486948
- Acronym / sponsor ID
- CT-156-C-002
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Software as a Medical Device (SaMD), Smartphone app
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Click Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Study start
- 6 May 2024 (actual)
- Primary completion
- 9 Aug 2024 (actual)
- Study completion
- 9 Aug 2024 (actual)
- First posted
- 5 Jul 2024 (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.
An exploratory, double-arm, 8-week study to explore the feasibility and acceptability of abbreviated treatment with CT-156 for people with Schizophrenia.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-156 | Active comparator | Device: CT-156Study App investigational treatment for adult patients diagnosed with Schizophrenia. |
| CT-156 + UXR | Experimental | Device: CT-156Study app investigational treatment for adult patients diagnosed with schizophrenia with up to five in-patient visits with three interviews for UXR (user experience research) arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Willing and able to provide written informed consent to participate in the study, attend study visits, and comply with study-related requirements and assessments.
- Is at least 18 years of age at the time of informed consent.
- Fluent in written and spoken English, confirmed by ability to read and understand the informed consent form.
- Lives in the United States.
- Meets diagnostic criteria for a primary diagnosis of schizophrenia as defined in the ICD-11 or DSM-5 for at least 6 months prior to screening.
Key exclusion criteria (13 listed)
- Has positive symptoms of schizophrenia that, in the opinion of the investigator, would preclude effective engagement in the treatment to improve functional impairment.
- Is currently receiving or has received concomitant therapy, defined as individual or group-based structured treatment (e.g., Cognitive Behavioral Therapy, Social Skills Training, Motivational Interviewing, or Vocational/Occupational Therapy), within 3 months (13 weeks) prior to screening per investigator assessment.
- Is currently treated with more than 2 antipsychotic medications (including more than 2 dosage forms).
- Meets ICD-11 or DSM-5 criteria for diagnoses not under investigation that will impact compliance to the protocol, including schizophreniform, schizoaffective, or psychosis non-specific disorders (post-traumatic stress disorder [PTSD], bipolar disorder, major depressive disorder, developmental disorders).
- Meets ICD-11 or DSM-5 criteria for a current episode of depression, mania or hypomania.
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-156CT-156 is a digital therapeutic (DTx) under development to treat patients 18 years of age and older with a diagnosis of schizophrenia under standard of care therapy who are on antipsychotic medication and not currently experiencing acute hallucinations or delusions. | Device | CT-156, CT-156 + UXR |
Primary outcome
Number of Days Used
Time frame: Day 0 to Week 8
Number of days the Study App is opened out of total days of treatment
Number of Times Study App is Opened
Time frame: Day 0 to Week 8
Number of times the Study App is opened during the treatment period
Number of Medication Check-ins Completed
Time frame: Day 0 to Week 8
Number of medication check-ins completed during the treatment period out of total assigned
Number of Assigned Tasks Completed
Time frame: Day 0 to Week 8
Number of assigned tasks completed during the treatment period
Average Duration of Use
Time frame: Day 0 to Week 8
Average duration of each App-use session
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 9 Jan 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 study director
Click Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-156 in people with Schizophrenia, run by Click Therapeutics, Inc. at 1 site 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 14 inclusion and 13 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 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Number of Days Used (time frame: Day 0 to Week 8). The study lists 5 primary outcomes in all. 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 9 Jan 2025.