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

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ClinicalTrials.gov Identifier: NCT05838625
Recruitment Status : Recruiting
First Posted : May 1, 2023
Last Update Posted : March 15, 2024
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Click Therapeutics, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Schizophrenia Device: Digital Therapeutic Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 432 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 31, 2023
Estimated Primary Completion Date : June 18, 2025
Estimated Study Completion Date : July 18, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Experiential negative symptoms [ Time Frame: Baseline to Week 16 ]
    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 :
  1. Motivation and pleasure symptoms [ Time Frame: Baseline to Week 8 ]
    Change from baseline in motivation and pleasure symptoms at Week 8, as assessed by CAINS-MAP

  2. Expressive negative symptoms [ Time Frame: Baseline to Weeks 8 and 16 ]
    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)

  3. Positive symptoms [ Time Frame: Baseline to Weeks 8 and 16 ]
    Change from baseline in positive symptoms at Weeks 8 and 16, as assessed by the Positive and Negative Syndrome Scale (PANSS)

  4. Social functioning [ Time Frame: Baseline to Weeks 8 and 16 ]
    Change from baseline in social functioning at Weeks 8 and 16, as assessed by the Personal and Social Performance Scale (PSP)

  5. Self-reported defeatist beliefs [ Time Frame: Baseline to Weeks 8 and 16 ]
    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)

  6. Patient global impression of improvement [ Time Frame: Weeks 8 and 16 ]
    Patient Global Impression of Improvement Scale (PGI-I) at Weeks 8 and 16


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05838625


Contacts
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Contact: Research Coordinator 877-352-5425 researchcoordinator@clicktherapeutics.com

Locations
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United States, New York
Click Therapeutics Recruiting
New York, New York, United States, 10013
Contact: Research Coordinator    877-352-5425    researchcoordinator@clicktherapeutics.com   
Sponsors and Collaborators
Click Therapeutics, Inc.
Boehringer Ingelheim
Investigators
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Study Director: Shaheen Lakhan, MD, PhD, FAAN Click Therapeutics
More Information
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Responsible Party: Click Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT05838625    
Other Study ID Numbers: CT-155-R-001
First Posted: May 1, 2023    Key Record Dates
Last Update Posted: March 15, 2024
Last Verified: March 2024

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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
Keywords provided by Click Therapeutics, Inc.:
Prescription digital therapeutic (PDT)
Software as a Medical Device (SaMD)
Smartphone app
Schizophrenia
Negative Symptoms
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders