Status:
COMPLETED
An Extension Study of a Second Course of a Digital Therapeutic for the Treatment of Experiential Negative Symptoms of Schizophrenia
Lead Sponsor:
Click Therapeutics, Inc.
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Schizophrenia
Negative Symptoms in Schizophrenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the proposed an open label extension (OLE) study is to evaluate the maintained efficacy and safety of a second consecutive course of Click Therapeutics Study App as an adjunct treatment...
Detailed Description
Click Therapeutics Study App is an interactive, software-based intervention for experiential negative symptoms of schizophrenia. The purpose of the proposed OLE study is to evaluate the maintained ef...
Eligibility Criteria
Inclusion
- A participant will be eligible for entry into the study if all the following criteria are met:
- Completed participation in NCT05838625 study within 7 days of the extension study Baseline Visit (Day 1).
- Is the sole user of an iPhone with an iPhone operating system (iOS) 14 or greater or a smartphone with an Android operating system (OS) 10 or greater and is willing to download and use the specified Study App required by the protocol.
- Is willing and able to receive SMS text messages and push messages on their smartphone.
- It is the owner of, and has regular access to, an email address.
- Has regular access to the Internet via cellular data plan and/or wi-fi.
- Had stable housing during NCT05838625, with no anticipated housing changes during the duration of this study.
Exclusion
- A participant will not be eligible for study entry if any of the following criteria are met:
- Has not completed the Week 16 Visit (Day 112) in the NCT05838625 study.
- Has a positive urine drug screening or participant self-reports use of synthetic cathinones (bath salts), synthetic cannabinoids (K2, Spice), inhalants, amphetamines (including MDMA/ecstasy), phencyclidine (PCP), cocaine, opiates, benzodiazepines, barbiturates, hallucinogens, or parenteral drugs. Participants with a positive urine drug test and/or recreational use of THC will not be excluded from the study at the discretion of the investigator. Participants with a positive urine drug screen (UDS) or self-report who have a valid prescription for barbiturates, benzodiazepines, or opiates will not be excluded from the study at the discretion of the investigator.
- Has suicidal ideation or behavior, as assessed by the C-SSRS:
- Participants with a "yes" response to either Items 4 or 5 on the C-SSRS Suicidal Ideation Item during the NCT05838625 study.
- Participants with a "yes" response on the C-SSRS Suicidal Behavior Items within the last 6 months (26 weeks) prior to or at the Baseline Visit
- Participants who, in the opinion of the investigator, present a serious risk of suicide.
Key Trial Info
Start Date :
September 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2025
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT06067984
Start Date
September 12 2023
End Date
August 22 2025
Last Update
October 16 2025
Active Locations (1)
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1
Click Therapeutics
New York, New York, United States, 10013