Digital Therapeutics for Schizophrenia

(CONVOKE Trial)

Recruiting at 126 trial locations

Overseen By Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Click Therapeutics, Inc.

Must be taking: Antipsychotics

Disqualifiers: Other DSM-5 diagnoses, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

432 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two digital treatments aimed at alleviating the negative symptoms of schizophrenia, which often include difficulties in socializing, working, or enjoying activities. The trial will determine if adding these digital tools, known as Prescription Digital Therapeutics (PDTs), to regular medication can improve these areas. Suitable participants have schizophrenia, are stable on their current medication, and struggle with social, work, or recreational activities. As a Phase 3 trial, this is the final step before FDA approval, providing an opportunity to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that both Digital Therapeutic A and B have been studied for treating negative symptoms in schizophrenia. Past studies on these digital treatments have shown promising results, with trials indicating a significant reduction in negative symptoms.

Regarding safety, previous studies have not found any major safety concerns for Digital Therapeutic A or B. These treatments are in advanced testing stages, having already passed earlier safety-focused tests, suggesting they are generally well-tolerated by patients.

While no treatment is completely risk-free, available data indicates that these digital therapeutics are safe to use alongside standard care for people with schizophrenia. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these digital therapeutics for schizophrenia because they offer a novel way to support treatment through technology. Traditional treatments for schizophrenia typically involve antipsychotic medications and therapy, focusing on managing positive symptoms like hallucinations. However, these digital therapeutics target experiential negative symptoms, such as social withdrawal and lack of motivation, which are often harder to treat. Digital Therapeutic A and B use interactive digital platforms to engage patients, providing personalized support and potentially improving adherence and outcomes. This innovative approach could complement standard care, offering a more holistic treatment option for individuals with schizophrenia.

What evidence suggests that this trial's treatments could be effective for schizophrenia?

This trial will evaluate the efficacy and safety of two treatments: Digital Therapeutic A and Digital Therapeutic B, as adjuncts to standard care for participants with experiential negative symptoms of schizophrenia. Research has shown that both Digital Therapeutic A and B yield promising results for people with schizophrenia. One study found that Digital Therapeutic A significantly reduced negative symptoms. Similarly, Digital Therapeutic B demonstrated a noticeable reduction in these symptoms over 16 weeks. These findings suggest that both treatments could help manage the negative symptoms of schizophrenia. Both therapies use digital tools to support regular care, aiming to improve the quality of life for those affected. ^{1 2 3 5 6}

Who Is on the Research Team?

Shaheen Lakhan, MD, PhD, FAAN

Principal Investigator

Click Therapeutics

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Prescription Digital Therapeutics

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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 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]

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]

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]

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]

Citations

1. boehringer-ingelheim.com boehringer-ingelheim.com/us/media/press-releases/boehringer-presents-pivotal-data-phase-iii-convoke-study

Boehringer presents pivotal data for Phase III CONVOKE ... CONVOKE was the first and only pivotal trial to show a statistically significant reduction in experiential negative symptoms of ...

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

Feasibility of a digital therapeutic for experiential negative ... Although DTx for people living with schizophrenia is more limited, promising results have emerged. For example, a study demonstrated significant ...

3. 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 Study of Two Digital Therapeutics for ... digital therapeutic CT-155 showing a statistically significant reduction in negative symptoms of schizophrenia.

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

Protocol for the Phase 3 CONVOKE Randomized Controlled ... Effectiveness, Engagement, and Safety of a Digital Therapeutic (CT-155/BI 3972080) for Treating Negative Symptoms in People With Schizophrenia: ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05838625

NCT05838625 | Study of Two Digital Therapeutics for the ... Evaluate the efficacy and safety of digital therapeutic A as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia.

6. neurologyadvisor.com neurologyadvisor.com/news/prescription-digital-therapeutic-ct-155-promising-for-negative-symptoms-of-schizophrenia/

Prescription Digital Therapeutic CT-155 Promising for ... Results showed the study met its primary endpoint demonstrating a significant reduction in experiential negative symptoms with CT-155, as ...