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

June 10, 2026 updated by: Click Therapeutics, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
464

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85226
        • Investigational center
      • Phoenix, Arizona, United States, 85012
        • Investigational center
    • California
      • Anaheim, California, United States, 92805
        • Investigational center
      • Culver City, California, United States, 90230
        • Investigational center
      • Garden Grove, California, United States, 92845
        • Investigational center
      • La Habra, California, United States, 90631
        • Investigational center
      • Long Beach, California, United States, 90807
        • Investigational center
      • Los Angeles, California, United States, 90025
        • Investigational center
      • Newport Beach, California, United States, 92660
        • Investigational center
      • Oceanside, California, United States, 92056
        • Investigational center
      • Orange, California, United States, 92868
        • Investigational center
      • San Bernardino, California, United States, 92408
        • Investigational center
      • Torrance, California, United States, 90504
        • Investigational center
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Investigational center
      • Hartford, Connecticut, United States, 06116
        • Investigational center
    • Florida
      • Hialeah, Florida, United States, 33016
        • Investigational center
      • Largo, Florida, United States, 33777
        • Investigational center
      • Miami, Florida, United States, 33156
        • Investigational center
      • Miami Lakes, Florida, United States, 33014
        • Investigational center
      • Orlando, Florida, United States, 32803
        • Investigational center
      • West Palm Beach, Florida, United States, 33407
        • Investigational center
    • Georgia
      • Atlanta, Georgia, United States, 30338
        • Investigational center
      • Augusta, Georgia, United States, 30912
        • Investigational center
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Investigational center
      • Springfield, Illinois, United States, 77030
        • Investigational center
      • Warrenville, Illinois, United States, 60555
        • Investigational center
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Investigational center
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Investigational center
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Investigational center
    • Mississippi
      • Flowood, Mississippi, United States, 39232
        • Investigational center
    • Missouri
      • St Louis, Missouri, United States, 63141
        • Investigational center
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Investigational center
    • Nevada
      • Las Vegas, Nevada, United States, 89124
        • Investigational center
    • New Jersey
      • Marlton, New Jersey, United States, 08054
        • Investigational center
    • New York
      • Cedarhurst, New York, United States, 11516
        • Investigational center
      • Glen Oaks, New York, United States, 11004
        • Investigational center
      • New York, New York, United States, 10013
        • Click Therapeutics
      • New York, New York, United States, 10027
        • Investigational center
      • Rochester, New York, United States, 14623
        • Investigational center
    • North Carolina
      • Charlotte, North Carolina, United States, 27608
        • Investigational center
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Investigational center
      • Cincinnati, Ohio, United States, 45267
        • Investigational center
      • Columbus, Ohio, United States, 43210
        • Investigational center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Investigational center
    • Pennsylvania
      • State College, Pennsylvania, United States, 16801
        • Investigational center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Investigational center
    • Texas
      • Austin, Texas, United States, 78752
        • Investigational center
      • Fort Worth, Texas, United States, 76104
        • Investigational center
      • Houston, Texas, United States, 77030
        • Investigational center
      • Irving, Texas, United States, 75062
        • Investigational center
      • Mesquite, Texas, United States, 75149
        • Investigational center
      • Plano, Texas, United States, 75093
        • Investigational center
    • Utah
      • Salt Lake City, Utah, United States, 84105
        • Investigational center
      • St. George, Utah, United States, 84770
        • Investigational center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ct-155
A software-based mobile application intended as an investigational treatment adjunctive to standard of care in individuals with experiential negative symptoms of schizophrenia
Device: CT-155
A software-based mobile application intended as a prescription digital therapeutic.
Experimental: Digital Control
A software-based mobile application intended as a digital control to engage participants without delivering therapeutic benefit
Device: Digital Control
A software-based mobile application intended as a digital control to engage participants without delivering therapeutic benefit

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Baseline to Week 16

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Baseline to Week 8
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)
Baseline to Weeks 8 and 16
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)
Baseline to Weeks 8 and 16
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)
Baseline to Weeks 8 and 16
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)
Baseline to Weeks 8 and 16
Patient global impression of improvement
Time Frame: Weeks 8 and 16
Patient Global Impression of Improvement Scale (PGI-I) at Weeks 8 and 16
Weeks 8 and 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Click Therapeutics, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Boehringer Ingelheim

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Viveca Livezey, MD, Click Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 23, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 1, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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