SchizophreniaPhase 3NCT06067984
An Extension Study of a Second Course of a Digital Therapeutic for the Treatment of Experiential Negative Symptoms of Schizophrenia
A Phase 3 study testing Study App in people with Schizophrenia and Negative Symptoms in Schizophrenia, run by Click Therapeutics, Inc. at 1 site in United States.
Trial summary
The purpose of the proposed an open label extension (OLE) study is to evaluate the maintained efficacy and safety of a second consecutive course of Click Therapeutics Study App as an adjunct treatment to standard of care (SOC) in participants who were on the Study App and have recently completed the Click Therapeutics… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Negative Symptoms in Schizophrenia
- What is being tested?
- Study App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2023to 22 Aug 2025
- Phase
- Phase 3
- 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
- A participant will be eligible for entry into the study if all the following criteria are met:
- Completed participation in NCT05838625 study within 7 days of the extension study Baseline Visit (Day 1).
- Is the sole user of an iPhone with an iPhone operating system (iOS) 14 or greater or a smartphone with an Android operating system (OS) 10 or greater and is willing to download and use the specified Study App required by the protocol.
- Is willing and able to receive SMS text messages and push messages on their smartphone.
- It is the owner of, and has regular access to, an email address.
- Has regular access to the Internet via cellular data plan and/or wi-fi.
- Had stable housing during NCT05838625, with no anticipated housing changes during the duration of this study.
Who cannot join
- A participant will not be eligible for study entry if any of the following criteria are met:
- Has not completed the Week 16 Visit (Day 112) in the NCT05838625 study.
- Has a positive urine drug screening or participant self-reports use of synthetic cathinones (bath salts), synthetic cannabinoids (K2, Spice), inhalants, amphetamines (including MDMA/ecstasy), phencyclidine (PCP), cocaine, opiates, benzodiazepines, barbiturates, hallucinogens, or parenteral drugs. Participants with a positive urine drug test and/or recreational use of THC will not be excluded from the study at the discretion of the investigator. Participants with a positive urine drug screen (UDS) or self-report who have a valid prescription for barbiturates, benzodiazepines, or opiates will not be excluded from the study at the discretion of the investigator.
- Has suicidal ideation or behavior, as assessed by the C-SSRS:
- Participants with a "yes" response to either Items 4 or 5 on the C-SSRS Suicidal Ideation Item during the NCT05838625 study.
- Participants with a "yes" response on the C-SSRS Suicidal Behavior Items within the last 6 months (26 weeks) prior to or at the Baseline Visit
- Participants who, in the opinion of the investigator, present a serious risk of suicide.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Arm, Open Label, 16-week Extension Study to Evaluate the Efficacy and Safety of a Second Course of a Digital Therapeutic as an Adjunct to Standard of Care Antipsychotic Therapy in Adult and Late Adolescent Participants With Experiential Negative Symptoms of Schizophrenia
The purpose of the proposed an open label extension (OLE) study is to evaluate the maintained efficacy and safety of a second consecutive course of Click Therapeutics Study App as an adjunct treatment to standard of care (SOC) in participants who were on the Study App and have recently completed the Click Therapeutics Randomized Clinical Trial NCT05838625.
Read the detailed description
Click Therapeutics Study App is an interactive, software-based intervention for experiential negative symptoms of schizophrenia.
The purpose of the proposed OLE study is to evaluate the maintained efficacy and safety of a second consecutive course of Click Therapeutics Study App as an adjunct treatment to standard of care (SOC) in participants who were on the Study App and have recently completed the Click Therapeutics Randomized Clinical Trial.
- Conditions
- Schizophrenia, Negative Symptoms in Schizophrenia
- Being tested
- Study App
- Keywords
- Prescription digital therapeutic (PDT), Software as a Medical Device (SaMD), Smartphone app, Schizophrenia, Negative Symptoms
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study AppDevice
An investigational prescription digital therapeutic in the form of a smartphone app.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Evaluate the efficacy and safety of a digital therapeutic as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia. Receives: Device: Study App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Experiential Negative Symptoms
Change from baseline to Week 16 in the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP)
Measured: Baseline to Week 16
Secondary outcomes (6)
Change in Experiential Negative Symptoms
Change from baseline to Week 8 in the CAINS-MAP
Measured: Baseline to Week 8
Change in Expressive Negative Symptoms
Change from baseline to Week 8 and to Week 16 in expressive negative symptoms, as assessed by the CAINS-EXP
Measured: Baseline to Weeks 8 and 16
Change in Positive Symptoms
Change from baseline to Week 16 in positive symptoms, as assessed by the Positive and Negative Syndrome Scale (PANSS)
Measured: Baseline to Week 16
Change in Social Functioning
Change from baseline to Week 16 in social functioning, as assessed by the Personal and Social Performance Scale (PSP)
Measured: Baseline to Week 16
Change in Defeatist Beliefs
Change from baseline to Week 16 in self-reported defeatist beliefs, as assessed by the Defeatist Beliefs Subscale of the Dysfunctional Attitude Scale (DAS)
Measured: Baseline to Week 16
Impression of Improvement
Patient Global Impression of Improvement Scale (PGI-I) at Week 16
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start12 Sep 2023
- Primary completion13 Jun 2025
- Study completion22 Aug 2025
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study evaluates the efficacy of a prescription digital therapeutic (PDT) in addition to standard of care (SOC) therapy for the treatment of experiential negative symptoms of schizophrenia in late adolescents and adults.
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Click Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Viveca Livezey, MD, Study director, Click Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067984
- Sponsor's protocol ID
- CT-155-E-001
- Status last verified
- Jun 2026
- First submitted
- 28 Sep 2023
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Arm, Open Label, 16-week Extension Study to Evaluate the Efficacy and Safety of a Second Course of a Digital Therapeutic as an Adjunct to Standard of Care Antipsychotic Therapy in Adult and Late Adolescent Participants With Experiential Negative Symptoms of Schizophrenia
- ClinicalTrials.gov ID
- NCT06067984
- Acronym / sponsor ID
- CT-155-E-001
- Conditions
- Schizophrenia, Negative Symptoms in Schizophrenia
- Keywords
- Prescription digital therapeutic (PDT), Software as a Medical Device (SaMD), Smartphone app, Schizophrenia, Negative Symptoms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Click Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Boehringer Ingelheim
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 13 Jun 2025 (actual)
- Study completion
- 22 Aug 2025 (actual)
- First posted
- 5 Oct 2023 (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.
The purpose of the proposed an open label extension (OLE) study is to evaluate the maintained efficacy and safety of a second consecutive course of Click Therapeutics Study App as an adjunct treatment to standard of care (SOC) in participants who were on the Study App and have recently completed the Click Therapeutics Randomized Clinical Trial NCT05838625.
Detailed description
Click Therapeutics Study App is an interactive, software-based intervention for experiential negative symptoms of schizophrenia.
The purpose of the proposed OLE study is to evaluate the maintained efficacy and safety of a second consecutive course of Click Therapeutics Study App as an adjunct treatment to standard of care (SOC) in participants who were on the Study App and have recently completed the Click Therapeutics Randomized Clinical Trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study evaluates the efficacy of a prescription digital therapeutic (PDT) in addition to standard of care (SOC) therapy for the treatment of experiential negative symptoms of schizophrenia in late adolescents and adults.
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Device: Study AppEvaluate the efficacy and safety of a digital therapeutic as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A participant will be eligible for entry into the study if all the following criteria are met:
- Completed participation in NCT05838625 study within 7 days of the extension study Baseline Visit (Day 1).
- Is the sole user of an iPhone with an iPhone operating system (iOS) 14 or greater or a smartphone with an Android operating system (OS) 10 or greater and is willing to download and use the specified Study App required by the protocol.
- Is willing and able to receive SMS text messages and push messages on their smartphone.
- It is the owner of, and has regular access to, an email address.
Key exclusion criteria (7 listed)
- A participant will not be eligible for study entry if any of the following criteria are met:
- Has not completed the Week 16 Visit (Day 112) in the NCT05838625 study.
- Has a positive urine drug screening or participant self-reports use of synthetic cathinones (bath salts), synthetic cannabinoids (K2, Spice), inhalants, amphetamines (including MDMA/ecstasy), phencyclidine (PCP), cocaine, opiates, benzodiazepines, barbiturates, hallucinogens, or parenteral drugs. Participants with a positive urine drug test and/or recreational use of THC will not be excluded from the study at the discretion of the investigator. Participants with a positive urine drug screen (UDS) or self-report who have a valid prescription for barbiturates, benzodiazepines, or opiates will not be excluded from the study at the discretion of the investigator.
- Has suicidal ideation or behavior, as assessed by the C-SSRS:
- Participants who, in the opinion of the investigator, present a serious risk of suicide.
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 |
|---|---|---|
| Study AppAn investigational prescription digital therapeutic in the form of a smartphone app. | Device | Arm A |
Primary outcome
Change in Experiential Negative Symptoms
Time frame: Baseline to Week 16
Change from baseline to Week 16 in the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP)
6 secondary outcomes
Change in Experiential Negative Symptoms
Time frame: Baseline to Week 8
Change in Expressive Negative Symptoms
Time frame: Baseline to Weeks 8 and 16
Change in Positive Symptoms
Time frame: Baseline to Week 16
Change in Social Functioning
Time frame: Baseline to Week 16
Change in Defeatist Beliefs
Time frame: Baseline to Week 16
Impression of Improvement
Time frame: Week 16
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 5 Jun 2026.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
Viveca Livezey, MD 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 Phase 3 study testing Study App in people with Schizophrenia and Negative Symptoms in 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 7 inclusion and 7 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 5 Jun 2026. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Experiential Negative Symptoms (time frame: Baseline to Week 16). 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 5 Jun 2026.