Digital Therapeutic for Schizophrenia

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

75 Participants Needed

Trial Summary

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 data supports the idea that Digital Therapeutic for Schizophrenia is an effective treatment?

The available research shows that smartphone apps for schizophrenia, like the Digital Therapeutic for Schizophrenia, have the potential to improve access to care. However, there is limited data on their effectiveness as many apps are not widely available or frequently updated. Some studies suggest that people with schizophrenia have positive attitudes towards using these apps, and they show promise in terms of acceptability and feasibility. However, more research is needed to confirm their effectiveness compared to other treatments. ^{1 2 3 4 5}

What data supports the effectiveness of this treatment for schizophrenia?

Research shows that smartphone apps for schizophrenia can enhance access to care and offer monitoring functionalities, although many are not yet widely available. Additionally, mobile-assisted cognitive behavioral therapy (CBT) has shown promise in addressing negative symptoms of schizophrenia, suggesting potential benefits of digital interventions. ^{1 2 3 4 5}

What safety data exists for the digital therapeutic for schizophrenia?

The research indicates that there is promising evidence for the acceptability, safety, feasibility, and efficacy of smartphone apps for schizophrenia, although detailed reporting on app engagement in trials is limited. The study on mobile-assisted cognitive behavioral therapy for negative symptoms suggests preliminary safety in an open single-arm trial. However, many research apps are not yet available on commercial marketplaces, and there is a need for better translation from research to sustainable interventions. ^{1 3 4 5 6}

Is the Digital Therapeutic for Schizophrenia safe for humans?

There is promising evidence for the safety and acceptability of smartphone apps for schizophrenia, but detailed safety data specific to the Digital Therapeutic for Schizophrenia is not provided in the available research. ^{1 3 4 5 6}

Is the digital treatment for schizophrenia a promising treatment?

Yes, digital treatments for schizophrenia are promising because they can make care more accessible and improve the quality of care. People with schizophrenia have shown positive attitudes towards using smartphone apps for treatment, and these apps can help with self-management skills and symptom monitoring. However, more work is needed to make these apps widely available and ensure they are updated regularly. ^{1 3 5 7 8}

How is the digital therapeutic for schizophrenia different from other treatments?

This digital therapeutic for schizophrenia is unique because it uses smartphone apps to enhance self-management skills and improve the therapeutic relationship with clinicians, unlike traditional treatments that may not focus on these aspects. It offers a novel way to engage patients through cognitive behavioral techniques and symptom monitoring, which can be more accessible and convenient than in-person sessions. ^{1 3 5 7 8}

What is the purpose of this trial?

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.

Research Team

Shaheen Lakhan, MD, PhD, FAAN

Principal Investigator

Click Therapeutics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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]

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Accessibility and availability of smartphone apps for schizophrenia. [2022]

2. United States 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. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Characterizing Smartphone Engagement for Schizophrenia: Results of a Naturalist Mobile Health Study. [2019]

4. Canada pubmed.ncbi.nlm.nih.gov

Mobile-Assisted Cognitive Behavioral Therapy for Negative Symptoms: Open Single-Arm Trial With Schizophrenia Patients. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Exploring engagement with the CBT-informed Actissist smartphone application for early psychosis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

The Functionality, Evidence, and Privacy Issues Around Smartphone Apps for the Top Neuropsychiatric Conditions. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Predicting symptom response and engagement in a digital intervention among individuals with schizophrenia and related psychoses. [2023]

8. Canada pubmed.ncbi.nlm.nih.gov

Development of the First Episode Digital Monitoring mHealth Intervention for People With Early Psychosis: Qualitative Interview Study With Clinicians. [2022]