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

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Digital Therapeutic
Sponsored by
Click Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Prescription digital therapeutic (PDT), Software as a Medical Device (SaMD), Smartphone app, Schizophrenia, Negative Symptoms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: A participant will be eligible for entry into the study if all of the following criteria are met: Has a primary diagnosis of schizophrenia. Is on a stable dose of antipsychotic medication(s). 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: Is currently treated with more than two antipsychotic medications. Meets DSM-5, for diagnoses not under investigation. Has participated in a CT-155 clinical study.

Sites / Locations

  • Click TherapeuticsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Digital Therapeutic A

Digital Therapeutic B

Arm Description

Evaluate the efficacy and safety of digital therapeutic A as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia.

Evaluate the efficacy and safety of digital therapeutic B as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Motivation and pleasure symptoms
Change from baseline in motivation and pleasure symptoms at Week 8, as assessed by CAINS-MAP
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)
Positive symptoms
Change from baseline in positive symptoms at Weeks 8 and 16, as assessed by the Positive and Negative Syndrome Scale (PANSS)
Social functioning
Change from baseline in social functioning at Weeks 8 and 16, as assessed by the Personal and Social Performance Scale (PSP)
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)
Patient global impression of improvement
Patient Global Impression of Improvement Scale (PGI-I) at Weeks 8 and 16

Full Information

First Posted
April 20, 2023
Last Updated
April 20, 2023
Sponsor
Click Therapeutics, Inc.
Collaborators
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT05838625
Brief Title
Study of Two Digital Therapeutics for the Treatment of Experiential Negative Symptoms of Schizophrenia
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 31, 2023 (Actual)
Primary Completion Date
May 7, 2024 (Anticipated)
Study Completion Date
June 6, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Click Therapeutics, Inc.
Collaborators
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Prescription digital therapeutic (PDT), Software as a Medical Device (SaMD), Smartphone app, Schizophrenia, Negative Symptoms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
432 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Digital Therapeutic A
Arm Type
Experimental
Arm Description
Evaluate the efficacy and safety of digital therapeutic A as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia.
Arm Title
Digital Therapeutic B
Arm Type
Experimental
Arm Description
Evaluate the efficacy and safety of digital therapeutic B as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia.
Intervention Type
Device
Intervention Name(s)
Digital Therapeutic
Intervention Description
A prescription digital therapeutic in the form of a smartphone app.
Primary Outcome Measure Information:
Title
Experiential negative symptoms
Description
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)
Time Frame
Baseline to Week 16
Secondary Outcome Measure Information:
Title
Motivation and pleasure symptoms
Description
Change from baseline in motivation and pleasure symptoms at Week 8, as assessed by CAINS-MAP
Time Frame
Baseline to Week 8
Title
Expressive negative symptoms
Description
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)
Time Frame
Baseline to Weeks 8 and 16
Title
Positive symptoms
Description
Change from baseline in positive symptoms at Weeks 8 and 16, as assessed by the Positive and Negative Syndrome Scale (PANSS)
Time Frame
Baseline to Weeks 8 and 16
Title
Social functioning
Description
Change from baseline in social functioning at Weeks 8 and 16, as assessed by the Personal and Social Performance Scale (PSP)
Time Frame
Baseline to Weeks 8 and 16
Title
Self-reported defeatist beliefs
Description
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)
Time Frame
Baseline to Weeks 8 and 16
Title
Patient global impression of improvement
Description
Patient Global Impression of Improvement Scale (PGI-I) at Weeks 8 and 16
Time Frame
Weeks 8 and 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A participant will be eligible for entry into the study if all of the following criteria are met: Has a primary diagnosis of schizophrenia. Is on a stable dose of antipsychotic medication(s). 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: Is currently treated with more than two antipsychotic medications. Meets DSM-5, for diagnoses not under investigation. Has participated in a CT-155 clinical study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Research Coordinator
Phone
877-352-5425
Email
researchcoordinator@clicktherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaheen Lakhan, MD, PhD, FAAN
Organizational Affiliation
Click Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Click Therapeutics
City
New York
State/Province
New York
ZIP/Postal Code
10013
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Research Coordinator
Phone
877-352-5425
Email
researchcoordinator@clicktherapeutics.com

12. IPD Sharing Statement

Learn more about this trial

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

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