Digital Therapeutic for Schizophrenia

No longer recruiting at 1 trial location

Overseen By Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Click Therapeutics, Inc.

Must not be taking: Synthetic cathinones, Synthetic cannabinoids

Disqualifiers: Suicidal ideation, Positive drug screening, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a digital app used alongside regular treatment for people with schizophrenia, particularly those experiencing negative symptoms such as lack of motivation or social withdrawal. The researchers seek to determine if the app remains effective and safe for individuals who participated in a previous study. Participants must have completed the earlier related trial and need access to a smartphone with internet to use the app. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for this trial?

The trial protocol does not specify if you need to stop your current medications. It seems you can continue your standard care medications while participating.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It seems likely that you can continue your existing medications, but it's best to confirm with the study team.

What prior data suggests that this digital therapeutic is safe for schizophrenia?

Research has shown that the Study App is generally safe for people with schizophrenia. A recent study reported no problems caused by the app and no serious issues that required stopping the study. This indicates that most users handle the app well. While this is encouraging, ongoing studies continue to carefully monitor safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for schizophrenia?

Unlike traditional treatments for schizophrenia, which often rely on medications like antipsychotics to manage symptoms, the digital therapeutic app offers a novel approach by serving as an adjunct to standard care. This app targets experiential negative symptoms of schizophrenia, such as social withdrawal and lack of motivation, which are typically harder to treat with medication alone. Researchers are excited because this digital therapeutic can provide personalized, interactive support right from a smartphone, potentially enhancing patient engagement and improving outcomes without additional side effects.

What evidence suggests that this digital therapeutic is effective for schizophrenia?

Research has shown that the Study App, which participants in this trial will use, helps reduce some difficult symptoms of schizophrenia. In earlier studies, people using the app experienced noticeable improvements in symptoms like low motivation and social withdrawal after 16 weeks, when combined with their usual treatments. This suggests the app can be a useful addition to regular medication, helping improve daily life and social skills. The evidence supports that this digital tool can enhance the lives of people with schizophrenia by addressing symptoms that are hard to treat with medication alone. ^{1 6 7 8 9}

Who Is on the Research Team?

Viveca Livezey, MD

Principal Investigator

Click Therapeutics

Are You a Good Fit for This Trial?

This trial is for individuals who have completed the Click Therapeutics Randomized Clinical Trial NCT05853900, have stable housing, and can use a specific Study App on an iPhone (iOS 14+) or Android (OS 10+). They must be able to receive messages and emails, and have internet access. Those with recent drug abuse or serious suicidal ideation are excluded.

Inclusion Criteria

It is the owner of, and has regular access to, an email address.

Is willing and able to receive SMS text messages and push messages on their smartphone.

I completed the NCT05853900 study less than a week ago.

Exclusion Criteria

Has suicidal ideation or behavior, as assessed by the C-SSRS:

Has not completed the Week 16 Visit (Day 112) in the NCT05853900 study.

I tested positive for certain drugs but not THC, or my use of THC is occasional.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a second course of the Click Therapeutics Study App as an adjunct to standard of care for 16 weeks

16 weeks

Regular app usage and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Evaluate the maintained efficacy and safety of a second consecutive course of the digital therapeutic

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Study App

Trial Overview The study tests the continued effectiveness and safety of using the Click Therapeutics Study App as an additional treatment alongside standard care in participants from a previous trial. It's an open label extension meaning everyone gets the app without being compared to a control group.

How Is the Trial Designed?

Group I: Arm A Experimental Treatment 1 Intervention

Evaluate the efficacy and safety of a digital therapeutic as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia.

Who Is Running the Clinical Trial?

Click Therapeutics, Inc.

Lead Sponsor

Trials

17

Recruited

2,900+

Boehringer Ingelheim

Industry Sponsor

Trials

2,566

Recruited

16,150,000+

Published Research Related to This Trial

In a study involving 38 patients with psychosis, primarily schizophrenia, machine learning models were able to moderately predict how individuals would engage with a smartphone app designed for psychosocial intervention and how their symptoms would change over a month.

The findings indicate that individual responses to smartphone interventions vary widely, and that baseline symptom data can help identify which patients are more likely to benefit from digital treatments, highlighting the importance of personalized approaches in mental health care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting symptom response and engagement in a digital intervention among individuals with schizophrenia and related psychoses. Price, GD., Heinz, MV., Nemesure, MD., et al.[2023]

The FREEDoM app aims to enhance shared decision-making and therapeutic relationships between clinicians and patients experiencing first-episode psychosis by providing timely and relevant clinical data, based on input from 11 treatment providers.

Clinicians suggested 31 adaptations to the app's design, with 18 being adopted, focusing on improving content and implementation strategies, which may increase the app's acceptance and integration into clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of the First Episode Digital Monitoring mHealth Intervention for People With Early Psychosis: Qualitative Interview Study With Clinicians. Stefancic, A., Rogers, RT., Styke, S., et al.[2022]

The study found that using a smartphone app for monitoring symptoms and cognitive functions in people with schizophrenia is feasible and acceptable in both India and the United States, suggesting its potential for global use.

Preliminary results indicate that app-based assessments may correlate with traditional clinical and cognitive evaluations, highlighting the app's promise for real-time monitoring, although further research is needed to confirm its long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone digital phenotyping, surveys, and cognitive assessments for global mental health: Initial data and clinical correlations from an international first episode psychosis study. Lakhtakia, T., Bondre, A., Chand, PK., et al.[2022]

Participants with psychosis engaged well with the Actissist app, responding to 47% of notifications, with the majority of interactions being initiated by the app itself, particularly in areas related to voice-hearing and paranoia.

The study suggests that financial incentives may enhance app engagement, indicating a need for future research to explore non-incentivized engagement in larger groups to better understand the app's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring engagement with the CBT-informed Actissist smartphone application for early psychosis. Eisner, E., Berry, N., Morris, R., et al.[2023]

A study analyzing user engagement with a schizophrenia smartphone app found that while 71% of users tried the mood-tracking feature, overall engagement was low, with only a small subset of users contributing the majority of entries.

The findings suggest that clinical involvement may be crucial for increasing engagement with mental health apps, as user interaction followed a power law distribution, indicating that a few users were highly active while most were not.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing Smartphone Engagement for Schizophrenia: Results of a Naturalist Mobile Health Study. Torous, J., Staples, P., Slaters, L., et al.[2019]

A review of schizophrenia apps revealed that while there are many research apps (60 identified), only a small number (9) are easily accessible to patients, indicating a gap between research and public availability.

Most marketplace apps (537 found) primarily offer psychoeducation and lack regular updates, with an average of 1121 days since the last update, highlighting the need for more clinically relevant and sustainable app interventions for schizophrenia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accessibility and availability of smartphone apps for schizophrenia. Kwon, S., Firth, J., Joshi, D., et al.[2022]

The mobile-assisted cognitive behavioral therapy for negative symptoms (mCBTn) was tested in a preliminary trial with 31 participants suffering from schizophrenia, showing excellent retention (87% at 18 weeks) and significant reductions in defeatist attitudes and experiential negative symptoms.

The results indicate that mCBTn is a feasible and potentially effective intervention for addressing negative symptoms in schizophrenia, supporting the defeatist attitude model and suggesting that technology-enhanced therapies can improve traditional psychosocial treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile-Assisted Cognitive Behavioral Therapy for Negative Symptoms: Open Single-Arm Trial With Schizophrenia Patients. Granholm, E., Holden, J., Dwyer, K., et al.[2020]

A study of 83 health-related smartphone apps for conditions like stroke, migraine, depression, Alzheimer's disease, and anxiety found that 69% included intervention components, but only 18% were evidence-based, raising concerns about their efficacy.

While most apps had privacy policies (77%), the complexity of these policies may make it difficult for users to understand how their data is being handled, highlighting a potential safety issue regarding user privacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Functionality, Evidence, and Privacy Issues Around Smartphone Apps for the Top Neuropsychiatric Conditions. Minen, MT., Gopal, A., Sahyoun, G., et al.[2022]

Citations

1. clicktherapeutics.com clicktherapeutics.com/news/boehringer-and-click-therapeutics-present-pivotal-data-for-investigational-prescription-digital-therapeutic-ct-155-showing-a-statistically-significant-reduction-in-negative-symptoms-of-schizophrenia

Stay up to date with news and updates The study met its primary endpoint, which was change in experiential negative symptoms from baseline to 16 weeks as measured by the Clinical ...

2. clicktherapeutics.com clicktherapeutics.com/news/boehringer-and-click-therapeutics-investigational-prescription-digital-therapeutic-ct-155-meets-primary-endpoint-in-convoke-study-for-negative-symptoms-in-schizophrenia

Stay up to date with news and updates CT-155 showed a reduction in experiential negative symptoms as an adjunct to standard of care antipsychotic therapy from baseline to week 16, as measured by ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12475125/

Feasibility of a digital therapeutic for experiential negative ... Experiential negative symptoms (ENS) of schizophrenia, such as asociality, anhedonia, and avolition, are associated with poor outcomes, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06067984

NCT06067984 | An Extension Study of a Second Course ... Evaluate the efficacy and safety of a digital therapeutic as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia.

5. researchprotocols.org researchprotocols.org/2025/1/e81293

Effectiveness, Engagement, and Safety of a Digital ... Background: Negative symptoms of schizophrenia, such as lack of motivation, pleasure, social interest, and expression, are key contributors ...

6. boehringer-ingelheim.com boehringer-ingelheim.com/human-health/mental-health/schizophrenia/phase-iii-convoke-study-meets-primary-endpoint

Phase III CONVOKE study meets primary endpoint Boehringer and Click's investigational PDT meets primary endpoint in CONVOKE study for experiential negative symptoms in schizophrenia.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05438160

NCT05438160 | Exploratory Study of a Digital Therapeutics ... CT-155 delivers an interactive, software-based intervention for schizophrenia. This is a multi-center, exploratory, single-arm study to evaluate the feasibility ...

8. nature.com nature.com/articles/s41537-025-00659-1

Feasibility of a digital therapeutic for experiential negative ... No app-related adverse events nor severe adverse events leading to discontinuation of the study were reported. Overall, the study demonstrated ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12541272/

Protocol for the Phase 3 CONVOKE Randomized Controlled ... Eligible participants were 18 years or older with a primary diagnosis of schizophrenia receiving stable antipsychotic medication for ≥12 weeks, ...