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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

No Placebo-Only Group

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with schizophrenia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 8 and 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 8 and 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 8 and 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Experiential negative symptoms

Secondary study objectives

Expressive negative symptoms

Motivation and pleasure symptoms

Patient global impression of improvement

+3 more

Awards & Highlights

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.

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.

0 / 1Eligibility criteria met