Study of Two Digital Therapeutics for the Treatment of Experiential Negative Symptoms of Schizophrenia

Schizophrenia Clinical Trial

— CONVOKE  

Official title:

A Randomized, Multicenter, 16-week Study to Evaluate the Efficacy and Safety of Two Prescription Digital Therapeutics 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: NCT05838625
• Other study ID #: CT-155-R-001
• Status: Recruiting
• Phase: Phase 3
• Start date: March 31, 2023
• Est. completion date: July 18, 2025

Study information

• Verified date: May 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

This study evaluates the efficacy of two prescription digital therapeutics (PDT) in addition to standard of care (SOC) therapy for the treatment of experiential negative symptoms of schizophrenia in late adolescents and adults.

Description:

The purpose of the proposed study is to evaluate the efficacy and safety of two prescription digital therapeutics as an adjunct treatment to SOC in participants 18 years of age or older diagnosed with experiential negative symptoms of schizophrenia.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 432
• Est. completion date: July 18, 2025
• Est. primary completion date: June 18, 2025
• 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 of the following criteria

are met:

1. Has a primary diagnosis of schizophrenia.

2. Is on a stable dose of antipsychotic medication(s).

3. Has obtained an average score of =2 (moderate to severe) in at least two of the three CAINS-MAP domains (Social, Work, or Recreational). Exclusion Criteria: A participant will not be eligible for study entry if any of the following criteria are

met:

1. Is currently treated with more than two antipsychotic medications (including more than two dosage forms).

2. Meets DSM-5, for diagnoses not under investigation.

3. Has participated in a CT-155 clinical study.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Device:
• Digital Therapeutic
A 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	Experiential negative symptoms	Change from baseline to Week 16 in experiential negative symptoms, as assessed by Clinical Assessment Interview for Negative Symptoms, Motivation and Pleasure Scale (CAINS-MAP)	Baseline to Week 16
Secondary	Motivation and pleasure symptoms	Change from baseline in motivation and pleasure symptoms at Week 8, as assessed by CAINS-MAP	Baseline to Week 8
Secondary	Expressive negative symptoms	Change from baseline in expressive negative symptoms at Weeks 8 and 16, as assessed by the Clinical Assessment Interview for Negative Symptoms, Expressivity Scale (CAINS-EXP)	Baseline to Weeks 8 and 16
Secondary	Positive symptoms	Change from baseline in positive symptoms at Weeks 8 and 16, as assessed by the Positive and Negative Syndrome Scale (PANSS)	Baseline to Weeks 8 and 16
Secondary	Social functioning	Change from baseline in social functioning at Weeks 8 and 16, as assessed by the Personal and Social Performance Scale (PSP)	Baseline to Weeks 8 and 16
Secondary	Self-reported defeatist beliefs	Change from baseline in self-reported defeatist beliefs at Weeks 8 and 16, as assessed by the Defeatist Beliefs Subscale of the Dysfunctional Attitudes Scale (DAS)	Baseline to Weeks 8 and 16
Secondary	Patient global impression of improvement	Patient Global Impression of Improvement Scale (PGI-I) at Weeks 8 and 16	Weeks 8 and 16