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Digital Therapeutics for Schizophrenia (CONVOKE Trial)
Verified Trial
Phase 3
Recruiting
Research Sponsored by Click Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Has a primary diagnosis of schizophrenia.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 8 and 16
Awards & highlights
CONVOKE Trial Summary
This trial studied if digital therapies plus standard care can reduce symptoms of schizophrenia in teens & adults.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves digital therapeutics, side effects may differ from traditional drugs but could include discomfort with technology use, increased screen time leading to eye strain or headaches, and potential privacy concerns.
CONVOKE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with schizophrenia.
CONVOKE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 8 and 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 8 and 16
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Experiential negative symptoms
Secondary outcome measures
Expressive negative symptoms
Motivation and pleasure symptoms
Patient global impression of improvement
+3 moreCONVOKE Trial Design
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.
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Who is running the clinical trial?
Click Therapeutics, Inc.Lead Sponsor
15 Previous Clinical Trials
2,549 Total Patients Enrolled
4 Trials studying Schizophrenia
367 Patients Enrolled for Schizophrenia
Boehringer IngelheimIndustry Sponsor
2,513 Previous Clinical Trials
11,340,792 Total Patients Enrolled
14 Trials studying Schizophrenia
5,170 Patients Enrolled for Schizophrenia
Shaheen Lakhan, MD, PhD, FAANStudy DirectorClick Therapeutics
2 Previous Clinical Trials
340 Total Patients Enrolled
1 Trials studying Schizophrenia
216 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with schizophrenia.I am on a consistent dose of medication for psychosis.
Research Study Groups:
This trial has the following groups:- Group 1: Digital Therapeutic A
- Group 2: Digital Therapeutic B
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies in this clinical trial for enrollees?
"Clinicaltrials.gov states that this clinical research is actively enrolling participants, commencing on March 31st 2023 and last upgraded April 20th of the same year."
Answered by AI
How extensive is the sample size of this investigation?
"Affirmative. Clinicaltrials.gov has data which shows that this medical trial, first posted on March 31st 2023, is actively enrolling patients. This project requires 432 individuals to join from a single site."
Answered by AI
Has the FDA sanctioned Digital Therapeutic for use in medical treatments?
"Our team at Power has assigned Digital Therapeutic A a score of 3 as there is evidence from multiple sources that it is safe and effective. This product is currently in Phase 3 trials, indicating the presence of supporting data for both efficacy and safety."
Answered by AI
Who else is applying?
What state do they live in?
New York
What site did they apply to?
Click Therapeutics
Tandem Clinical Research, Marrero
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Most responsive sites:
- Tandem Clinical Research, Marrero: < 24 hours
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