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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

Study 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.Check my eligibility

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.See study design

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

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Secondary outcome measures

Change in Defeatist Beliefs

Change in Experiential Negative Symptoms

Change in Expressive Negative Symptoms

+3 more

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Click Therapeutics, Inc.Lead Sponsor

15 Previous Clinical Trials

2,751 Total Patients Enrolled

4 Trials studying Schizophrenia

583 Patients Enrolled for Schizophrenia

Boehringer IngelheimIndustry Sponsor

2,507 Previous Clinical Trials

11,340,691 Total Patients Enrolled

14 Trials studying Schizophrenia

5,386 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Federal Drug Administration sanctioned Arm A?

"Our team has assigned a score of 3 to Arm A, due to the numerous rounds of safety testing and evidence suggesting its efficacy. This is further bolstered by this being a Phase 3 trial."

Answered by AI

What is the overall participant count for this research endeavor?

"Affirmative. According to clinicaltrials.gov, this medical test is actively searching for participants and has been since September 12th 2023; with the most recent update on the 28th of that month. A total of 216 individuals are needed from a single site."

Answered by AI

Is there currently an open call for individuals to join the experiment?

"Affirmative. Clinicaltrials.gov's records demonstrate that this medical study, first published on September 12th 2023, is actively recruiting volunteers. At the moment, 216 patients are being sought from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Extension Study of a Second Course of a Digital Therapeutic for the Treatment of Experiential Negative Symptoms of Schizophrenia

2023. "An Extension Study of a Second Course of a Digital Therapeutic for the Treatment of Experiential Negative Symptoms of Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06067984.