An Extension Study of a Second Course of a Digital Therapeutic for the Treatment of Experiential Negative Symptoms of Schizophrenia
Study Details
Study Description
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 to standard of care (SOC) in participants who were on the Study App and have recently completed the Click Therapeutics Randomized Clinical Trial NCT05853900.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 efficacy and safety of a second consecutive course of Click Therapeutics Study App as an adjunct treatment to standard of care (SOC) in participants who were on the Study App and have recently completed the Click Therapeutics Randomized Clinical Trial.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm A Evaluate the efficacy and safety of a digital therapeutic as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia. |
Device: Study App
An investigational prescription digital therapeutic in the form of a smartphone app.
|
Outcome Measures
Primary Outcome Measures
- Change in Experiential Negative Symptoms [Baseline to Week 16]
Change from baseline to Week 16 in the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP)
Secondary Outcome Measures
- Change in Experiential Negative Symptoms [Baseline to Week 8]
Change from baseline to Week 8 in the CAINS-MAP
- Change in Expressive Negative Symptoms [Baseline to Weeks 8 and 16]
Change from baseline to Week 8 and to Week 16 in expressive negative symptoms, as assessed by the CAINS-EXP
- Change in Positive Symptoms [Baseline to Week 16]
Change from baseline to Week 16 in positive symptoms, as assessed by the Positive and Negative Syndrome Scale (PANSS)
- Change in Social Functioning [Baseline to Week 16]
Change from baseline to Week 16 in social functioning, as assessed by the Personal and Social Performance Scale (PSP)
- Change in Defeatist Beliefs [Baseline to Week 16]
Change from baseline to Week 16 in self-reported defeatist beliefs, as assessed by the Defeatist Beliefs Subscale of the Dysfunctional Attitude Scale (DAS)
- Impression of Improvement [Week 16]
Patient Global Impression of Improvement Scale (PGI-I) at Week 16
Eligibility Criteria
Criteria
Inclusion Criteria:
A participant will be eligible for entry into the study if all the following criteria are met:
-
Completed participation in NCT05853900 (Week 20) 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 NCT05853900, with no anticipated housing changes during the duration of this study.
Exclusion Criteria:
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 NCT05853900 study.
-
Has a positive urine drug screening at Baseline Visit for amphetamines (including MDMA/ecstasy), phencyclidine (PCP), cocaine, opiates, benzodiazepines, or barbiturates. Participants with a positive urine drug test and/or recreational use of THC may be recruited 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 NCT05853900 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Click Therapeutics | New York | New York | United States | 10013 |
Sponsors and Collaborators
- Click Therapeutics, Inc.
- Boehringer Ingelheim
Investigators
- Study Director: Shaheen Lakhan, MD, PhD, FAAN, Click Therapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CT-155-E-001