Digital Therapeutics for Schizophrenia

(CONVOKE Trial)

Recruiting at 126 trial locations

Overseen By Research Coordinator

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: Click Therapeutics, Inc.

Must be taking: Antipsychotics

Disqualifiers: Other DSM-5 diagnoses, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study evaluates the efficacy of two prescription digital therapeutics (PDT) in addition to standard of care (SOC) therapy for the treatment of experiential negative symptoms of schizophrenia in late adolescents and adults.

Will I have to stop taking my current medications?

The trial requires that you stay on a stable dose of your current antipsychotic medication.

What data supports the effectiveness of the treatment Prescription Digital Therapeutics for schizophrenia?

Prescription Digital Therapeutics (PDTs) have shown effectiveness in treating conditions like substance use disorders and opioid use disorder, as they are rigorously evaluated for safety and effectiveness and authorized by the FDA. This suggests that similar digital treatments could potentially be beneficial for managing schizophrenia by improving adherence and supporting clinical decision-making. ^{1 2 3 4 5}

Is digital therapeutics generally safe for humans?

There is limited safety data available for digital therapeutics, but they are regulated by the FDA, which means they undergo some level of safety evaluation. However, specific risks and adverse events are not well-documented, indicating a need for more research on their safety. ^{3 6 7 8 9}

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

This digital therapeutic treatment for schizophrenia is unique because it uses software-based interventions delivered on mobile devices, allowing for remote and private access to therapy. Unlike traditional treatments, it is rigorously evaluated for safety and effectiveness and is authorized by the FDA, offering a flexible approach to meet individual patient needs. ^{1 3 6 8 10}

Research Team

Shaheen Lakhan, MD, PhD, FAAN

Principal Investigator

Click Therapeutics

Eligibility Criteria

This trial is for late adolescents and adults with a primary diagnosis of schizophrenia. Participants must be on a stable dose of antipsychotic medication and have moderate to severe scores in at least two domains (Social, Work, or Recreational) related to negative symptoms.

Inclusion Criteria

Has obtained an average score of ≥2 (moderate to severe) in at least two of the three CAINS-MAP domains (Social, Work, or Recreational).

I have been diagnosed with schizophrenia.

I am on a consistent dose of medication for psychosis.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive digital therapeutics A or B as an adjunct to standard-of-care antipsychotic therapy

16 weeks

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Prescription Digital Therapeutics (Behavioural Intervention)

Trial Overview The study is testing the effectiveness of two prescription digital therapeutics when used alongside standard therapy for treating experiential negative symptoms like reduced social engagement or lack of motivation in people with schizophrenia.

Participant Groups

Group I: Digital Therapeutic B Experimental Treatment 1 Intervention

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

Group II: Digital Therapeutic A Experimental Treatment 1 Intervention

Evaluate the efficacy and safety of digital therapeutic A 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

Prescription digital therapeutics (PDTs) are FDA-authorized software treatments that effectively address behavioral aspects of various diseases, including substance use disorders and chronic insomnia, with nine currently available options.

Recent studies have provided real-world evidence demonstrating the clinical and cost-effectiveness of PDTs for treating substance use disorders, highlighting their potential role in improving patient recovery outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Rise of Prescription Digital Therapeutics in Behavioral Health. Brezing, CA., Brixner, DI.[2023]

In a study of 3144 patients with opioid use disorder, the prescription digital therapeutic (PDT) reSET-O showed high engagement, with 80% of patients completing at least 8 out of 67 therapeutic modules, which is linked to improved treatment outcomes.

Patients who engaged with reSET-O demonstrated significant abstinence rates, with 66% abstinent in the last 4 weeks of treatment and 91% meeting the responder definition, indicating that this digital tool can effectively support traditional buprenorphine therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world evidence for a prescription digital therapeutic to treat opioid use disorder. Maricich, YA., Xiong, X., Gerwien, R., et al.[2021]

In a study involving 602 patients with substance use disorders who used the reSET® digital therapeutic, there was a high engagement level, with a median of 33 out of 61 lessons completed and 52% of patients finishing all core modules.

The treatment showed promising outcomes, with a retention rate of 74% during the last four weeks and 62% of patients achieving abstinence by the end of the 12-week program, indicating the potential effectiveness of digital therapeutics in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of real-world outcomes associated with use of a prescription digital therapeutic to treat substance use disorders. Xiong, X., Braun, S., Stitzer, M., et al.[2023]

A new FDA-approved digital adherence system for aripiprazole uses an ingestible sensor to track medication intake, providing real-time data to both patients and physicians, which can help improve medication adherence in patients with serious mental illness.

This technology not only reveals adherence patterns but also allows for more focused therapeutic discussions during appointments, potentially enhancing the patient-physician relationship and improving treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of an Ingestible, Sensor-Based Digital Adherence System to Strengthen the Therapeutic Relationship in Serious Mental Illness. Richey, AG., Kovacs, I., Browne, S.[2022]

The study evaluates a digital medicine system (DMS) designed to monitor medication adherence in adults with schizophrenia, schizoaffective disorder, or first-episode psychosis, involving a multicenter trial across five NHS Trusts in the UK over 8 weeks.

The DMS integrates an oral sensor tablet with antipsychotics and a wearable patch to track medication ingestion and physical activity, aiming to enhance adherence monitoring and support clinical decision-making for treatment planning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hummingbird Study: a study protocol for a multicentre exploratory trial to assess the acceptance and performance of a digital medicine system in adults with schizophrenia, schizoaffective disorder or first-episode psychosis. Fowler, JC., Cope, N., Knights, J., et al.[2023]

Prescription digital therapeutics (PDTs) are rapidly evolving, but the FDA's regulatory processes have not kept pace, leading to misunderstandings about their evaluation and approval.

Digital therapeutics offer significant advantages over traditional treatments, such as improved access to evidence-based therapies and the potential to enhance health equity by addressing disparities in care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA regulations and prescription digital therapeutics: Evolving with the technologies they regulate. Watson, A., Chapman, R., Shafai, G., et al.[2023]

The digital medicine system (DMS) for monitoring adherence to aripiprazole demonstrated a high ingestion detection rate of 96.6% in a study involving 59 healthy volunteers, indicating its efficacy in tracking medication intake.

The system showed acceptable latency times for detecting ingestion, with most signals transmitted to the server within 10 minutes, and no serious adverse events were reported, highlighting its safety for use in psychiatric patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Digital Medicine System in Psychiatry: Ingestion Detection Rate and Latency Period. Profit, D., Rohatagi, S., Zhao, C., et al.[2022]

In a study involving 67 adults with schizophrenia, 82.1% of patients were able to independently replace the wearable sensor used in the Digital Medicine System (DMS), indicating good usability of the device.

By the end of the 8-week treatment, 78% of patients reported being satisfied with the DMS, suggesting it could be a valuable tool for monitoring medication adherence in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability of a novel digital medicine system in adults with schizophrenia treated with sensor-embedded tablets of aripiprazole. Peters-Strickland, T., Pestreich, L., Hatch, A., et al.[2023]

The DTX Risk Assessment Canvas is a newly developed tool designed to help researchers and developers identify and reflect on the potential negative consequences and risks associated with digital therapeutics (DTX), organized into 15 thematic blocks.

This canvas can be used during the design and development phase of DTX to implement strategies for risk mitigation and monitoring, ensuring patient safety and addressing adverse effects effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Potential Risks of Digital Therapeutics (DTX): The DTX Risk Assessment Canvas. Denecke, K., May, R., Gabarron, E., et al.[2023]

Digital therapeutics are innovative software-based interventions designed to prevent, manage, or treat various medical conditions, including mental health disorders and chronic diseases, and they offer flexibility to meet individual patient needs.

Despite their potential benefits, none of the currently available digital therapeutics have received FDA clearance, highlighting the need for regulatory frameworks and user-centered approaches to ensure their effective integration into healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introduction of digital therapeutics. Hong, JS., Wasden, C., Han, DH.[2021]

References

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

The Rise of Prescription Digital Therapeutics in Behavioral Health. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Real-world evidence for a prescription digital therapeutic to treat opioid use disorder. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Evaluation of real-world outcomes associated with use of a prescription digital therapeutic to treat substance use disorders. [2023]

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

Use of an Ingestible, Sensor-Based Digital Adherence System to Strengthen the Therapeutic Relationship in Serious Mental Illness. [2022]

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

Hummingbird Study: a study protocol for a multicentre exploratory trial to assess the acceptance and performance of a digital medicine system in adults with schizophrenia, schizoaffective disorder or first-episode psychosis. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

FDA regulations and prescription digital therapeutics: Evolving with the technologies they regulate. [2023]

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

Developing a Digital Medicine System in Psychiatry: Ingestion Detection Rate and Latency Period. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Usability of a novel digital medicine system in adults with schizophrenia treated with sensor-embedded tablets of aripiprazole. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Assessing the Potential Risks of Digital Therapeutics (DTX): The DTX Risk Assessment Canvas. [2023]

10. Ireland pubmed.ncbi.nlm.nih.gov

Introduction of digital therapeutics. [2021]