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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Device: Digital Therapeutic

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 432
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Research Coordinator; Phone Number: 877-352-5425; Email: researchcoordinator@clicktherapeutics.com

Study Locations

• United States
  • New York
    • New York, New York, United States, 10013
      • Recruiting
      • Click Therapeutics
      • Contact: Research Coordinator; Phone Number: 877-352-5425; Email: researchcoordinator@clicktherapeutics.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital Therapeutic A; Evaluate the efficacy and safety of digital therapeutic A as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia.	Device: Digital Therapeutic; A prescription digital therapeutic in the form of a smartphone app.
Experimental: Digital Therapeutic B; Evaluate the efficacy and safety of digital therapeutic B as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia.	Device: Digital Therapeutic; A prescription digital therapeutic in the form of a smartphone app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motivation and pleasure symptoms	Change from baseline in motivation and pleasure symptoms at Week 8, as assessed by CAINS-MAP	Baseline to Week 8
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
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
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
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
Patient global impression of improvement	Patient Global Impression of Improvement Scale (PGI-I) at Weeks 8 and 16	Weeks 8 and 16

Collaborators and Investigators

• Sponsor: Click Therapeutics, Inc.
• Collaborators: Boehringer Ingelheim
• Investigators: Study Director: Shaheen Lakhan, MD, PhD, FAAN, Click Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2023
• Primary Completion (Estimated): June 18, 2025
• Study Completion (Estimated): July 18, 2025

Study Registration Dates

• First Submitted: April 20, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Schizophrenia; Smartphone app; Negative Symptoms; Software as a Medical Device (SaMD); Prescription digital therapeutic (PDT)
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: CT-155-R-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No