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Digital Therapeutic for Schizophrenia
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to weeks 8 and 16
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial looks at the continued safety & effectiveness of an app as treatment, after recently completing a clinical trial.
Who is the study for?
This trial is for individuals who have completed the Click Therapeutics Randomized Clinical Trial NCT05853900, have stable housing, and can use a specific Study App on an iPhone (iOS 14+) or Android (OS 10+). They must be able to receive messages and emails, and have internet access. Those with recent drug abuse or serious suicidal ideation are excluded.
What is being tested?
The study tests the continued effectiveness and safety of using the Click Therapeutics Study App as an additional treatment alongside standard care in participants from a previous trial. It's an open label extension meaning everyone gets the app without being compared to a control group.
What are the potential side effects?
Since this intervention involves a digital therapeutic app, traditional medication side effects are not applicable. However, potential side effects may include discomfort from prolonged screen time or stress if technical issues arise while using the app.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to weeks 8 and 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to weeks 8 and 16
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change in Defeatist Beliefs
Change in Experiential Negative Symptoms
Change in Expressive Negative Symptoms
+3 moreAwards & 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
1Treatment groups
Experimental Treatment
Group I: Arm AExperimental Treatment1 Intervention
Evaluate the efficacy and safety of a digital therapeutic 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
16 Previous Clinical Trials
2,823 Total Patients Enrolled
5 Trials studying Schizophrenia
641 Patients Enrolled for Schizophrenia
Boehringer IngelheimIndustry Sponsor
2,554 Previous Clinical Trials
15,897,219 Total Patients Enrolled
15 Trials studying Schizophrenia
5,526 Patients Enrolled for Schizophrenia
Shaheen Lakhan, MD, PhD, FAANStudy DirectorClick Therapeutics
2 Previous Clinical Trials
556 Total Patients Enrolled
1 Trials studying Schizophrenia
432 Patients Enrolled for Schizophrenia