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Completed

NCT Number: NCT05838625

Study of Two Digital Therapeutics for the Treatment of 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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational center, Chandler, Arizona, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (including more than two dosage forms).
  • Meets DSM-5, for diagnoses not under investigation.
  • Has participated in a CT-155 clinical study.

Treatment and study plan

CT-155

Device

A software-based mobile application intended as a prescription digital therapeutic.

Digital Control

Device

A software-based mobile application intended as a digital control to engage participants without delivering therapeutic benefit

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Click Therapeutics, Inc.

Industry

Collaborators

  • Boehringer Ingelheim

Registry information

Official study 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

Acronym: CONVOKE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 1, 2023
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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