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

Schizophrenia Clinical Trial

Official title:

A Single-Arm, Open Label, 16-week Extension Study to Evaluate the Efficacy and Safety of a Second Course of a Digital Therapeutic as an Adjunct to Standard of Care Antipsychotic Therapy in Adult and Late Adolescent Participants With Experiential Negative Symptoms of Schizophrenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06067984
• Other study ID #: CT-155-E-001
• Status: Recruiting
• Phase: Phase 3
• Start date: September 12, 2023
• Est. completion date: October 24, 2024

Study information

• Verified date: February 2024
• Source: Click Therapeutics, Inc.
• Contact: Research Coordinator
• Phone: 877-352-5425
• Email: researchcoordinator[@]clicktherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: October 24, 2024
• Est. primary completion date: September 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 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:

1. Participants with a "yes" response to either Items 4 or 5 on the C-SSRS Suicidal Ideation Item during the NCT05853900 study.

2. 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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Device:
• Study App
An investigational prescription digital therapeutic in the form of a smartphone app.

Locations

Country	Name	City	State
United States	Click Therapeutics	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Click Therapeutics, Inc.	Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Experiential Negative Symptoms	Change from baseline to Week 16 in the Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP)	Baseline to Week 16
Secondary	Change in Experiential Negative Symptoms	Change from baseline to Week 8 in the CAINS-MAP	Baseline to Week 8
Secondary	Change in Expressive Negative Symptoms	Change from baseline to Week 8 and to Week 16 in expressive negative symptoms, as assessed by the CAINS-EXP	Baseline to Weeks 8 and 16
Secondary	Change in Positive Symptoms	Change from baseline to Week 16 in positive symptoms, as assessed by the Positive and Negative Syndrome Scale (PANSS)	Baseline to Week 16
Secondary	Change in Social Functioning	Change from baseline to Week 16 in social functioning, as assessed by the Personal and Social Performance Scale (PSP)	Baseline to Week 16
Secondary	Change in Defeatist Beliefs	Change from baseline to Week 16 in self-reported defeatist beliefs, as assessed by the Defeatist Beliefs Subscale of the Dysfunctional Attitude Scale (DAS)	Baseline to Week 16
Secondary	Impression of Improvement	Patient Global Impression of Improvement Scale (PGI-I) at Week 16	Week 16