Digital Therapeutics for Schizophrenia
(CONVOKE Trial)
Recruiting in Palo Alto (17 mi)
+126 other locations
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.
12345Is 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.
36789How 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.
136810Eligibility 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Digital Therapeutic BExperimental Treatment1 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 AExperimental Treatment1 Intervention
Evaluate the efficacy and safety of digital therapeutic A as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Investigational center 461Chandler, AZ
Investigational center 439Phoenix, AZ
Investigational center 401Anaheim, CA
Investigational center 411Culver City, CA
More Trial Locations
Loading ...
Who Is Running the Clinical Trial?
Click Therapeutics, Inc.Lead Sponsor
Boehringer IngelheimIndustry Sponsor
References
The Rise of Prescription Digital Therapeutics in Behavioral Health. [2023]Medicine is evolving to incorporate digital technologies of all kinds-technologies that may improve patient health, reduce clinician workload, lower costs, reduce health disparities, and expand access to needed treatments. Prescription digital therapeutics (PDTs) are an emerging technology with particular potential. These are software-based treatments delivered on mobile devices that address the behavioral dimensions of many diseases and conditions. Unlike health and wellness apps, PDTs are rigorously evaluated for safety and effectiveness and are authorized by the US Food and Drug Administration (FDA). Nine PDTs are currently authorized to treat conditions such as substance use disorders, attention-deficit disorder, and chronic insomnia. The findings reported in two recent research papers published by Advances in Therapy related to use of PDTs for substance use disorder and opioid use disorder provide real-world evidence of clinical and cost effectiveness, strengthening the evidence base for these technologies and suggesting a role for these technologies in the efforts to help patients recover from these often-chronic and deadly conditions.
Real-world evidence for a prescription digital therapeutic to treat opioid use disorder. [2021]To evaluate patient engagement and usage of a prescription digital therapeutic (PDT) and associated outcomes of opioid use and treatment retention in a large real-world dataset of patients with opioid use disorder (OUD) treated with buprenorphine medication for opioid use disorder (MOUD). PDTs are software-based disease treatments evaluated for safety and effectiveness in randomized clinical trials (RCTs), and authorized by the U.S. Food and Drug Administration (FDA) to treat disease with approved directions for use (label).
Evaluation of real-world outcomes associated with use of a prescription digital therapeutic to treat substance use disorders. [2023]Digital therapeutics can expand the reach and fidelity of behavioral treatment for substance use disorders (SUDs). This analysis evaluated real-world engagement and clinical outcomes in patients diagnosed with SUD who were prescribed reSET®, an FDA-authorized prescription digital therapeutic (PDT).
Use of an Ingestible, Sensor-Based Digital Adherence System to Strengthen the Therapeutic Relationship in Serious Mental Illness. [2022]Serious mental illness is a chronic condition that requires long-term pharmacological treatment. Adherence to oral antipsychotic medication has specific nuances that affects patients and physicians alike. For patients with serious mental illness, nonadherence increases their risk of hospitalization and relapse. Nonadherence is a formidable barrier for physicians in accurately assessing medication efficacy and helping patients achieve their fullest potential. A digital adherence system approved by the Food and Drug Administration can provide near-real time aripiprazole ingestion information. The system records ingestions through an embedded ingestible sensor in oral aripiprazole, which sends a transient local signal to a patch worn on the patient's torso that is then stored on a paired smartphone app. With patient permission, these data can be viewed remotely by their physician, along with a patient's mood, activity, and time spent resting. Such data are able to do the following: reveal broad patterns of medication adherence behavior to the patient as well as their physician; help physicians and patients understand and create more realistic expectations for adherence; promote discussion of treatment options; and minimize therapeutic appointment time devoted to determining actual adherence, thereby maximizing the time available to address each patient's distinctive reasons for their adherence pattern. Crucially, extra time created during appointments can be used to strengthen the therapeutic relationship, which may translate into both improvements in adherence and patient attitude toward their medication. Future investigations are needed to examine how this technology impacts the development of training and best practice guidelines for its use. Otherwise, the potential benefits of this technology may be lost, or worse, inadequate and inappropriate use may harm the therapeutic relationship.
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]In patients with schizophrenia, medication adherence is important for relapse prevention, and effective adherence monitoring is essential for treatment planning. A digital medicine system (DMS) has been developed to objectively monitor patient adherence and support clinical decision making regarding treatment choices. This study assesses the acceptance and performance of the DMS in adults with schizophrenia, schizoaffective disorder or first-episode psychosis and in healthcare professionals (HCPs).
FDA regulations and prescription digital therapeutics: Evolving with the technologies they regulate. [2023]Technological progress in digital therapeutics-and, in particular prescription digital therapeutics (PDTs)-has outpaced the processes that the Food and Drug Administration (FDA) uses to regulate such products. Digital therapeutics have entered the health care ecosystem so rapidly that substantial misunderstandings exist about how they are evaluated and regulated by the FDA. This review briefly explains the relevant regulatory history of software as medical devices (SaMDs) and reviews the current regulatory landscape in which prescription and non-prescription digital therapeutics are developed and approved for use. These are important issues because PDTs, and digital therapeutics in general, are an explosively growing field in medicine and offer many advantages over conventional face-to-face treatments for the behavioral dimensions of a wide range of conditions and disease states. By allowing access to evidence-based therapies remotely and privately, digital therapeutics can reduce existing disparities in care and improve health equity. But clinicians, payers, and other healthcare stakeholders must appreciate the rigor of the regulatory frameworks within which PDTs are approved for use.
Developing a Digital Medicine System in Psychiatry: Ingestion Detection Rate and Latency Period. [2022]A digital medicine system (DMS) has been developed to measure and report adherence to an atypical antipsychotic, aripiprazole, in psychiatric patients. The DMS consists of 3 components: ingestible sensor embedded in a medication tablet, wearable sensor, and secure mobile and cloud-based applications. An umbrella study protocol was designed to rapidly assess the technical performance and safety of the DMS in multiple substudies to guide the technology development.
Usability of a novel digital medicine system in adults with schizophrenia treated with sensor-embedded tablets of aripiprazole. [2023]Digital medicine system (DMS) is a novel drug-device combination that objectively measures and reports medication ingestion. The DMS consists of medication embedded with an ingestible sensor (digital medicine), a wearable sensor, and software applications. This study evaluated usability of the DMS in adults with schizophrenia rated by both patients and their health care providers (HCPs) during 8-week treatment with prescribed doses of digital aripiprazole.
Assessing the Potential Risks of Digital Therapeutics (DTX): The DTX Risk Assessment Canvas. [2023]Digital therapeutics (DTX), i.e., health interventions that are provided through digital means, are increasingly available for use; in some countries, physicians can even prescribe selected DTX following a reimbursement by health insurances. This results in an increasing need for methodologies to consider and monitor DTX's negative consequences, their risks to patient safety, and possible adverse events. However, it is completely unknown which aspects should be subject to surveillance given the missing experiences with the tools and their negative impacts.
Introduction of digital therapeutics. [2021]Digital therapeutics are an emerging type of medical therapy and are defined as evidence-based therapeutic interventions for patients by means of qualified software programs to prevent, manage, or treat medical conditions. Today, digital therapeutics products are on the market or under development for a wide range of medical conditions such as diabetes, oncology treatment management, and neuropsychiatric disorders including anxiety disorder, depression, and substance use disorder. Digital therapeutics can be more flexible than other treatment methods to address patients' individual needs.