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

NCT ID: NCT05838625

Last Updated: 2025-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

464 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-31

Study Completion Date

2025-07-23

Brief Summary

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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

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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.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Digital Therapeutic

Intervention Type DEVICE

A prescription digital therapeutic in the form of a smartphone app.

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.

Group Type EXPERIMENTAL

Digital Therapeutic

Intervention Type DEVICE

A prescription digital therapeutic in the form of a smartphone app.

Interventions

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Digital Therapeutic

A prescription digital therapeutic in the form of a smartphone app.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

Click Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Viveca Livezey, MD

Role: STUDY_DIRECTOR

Click Therapeutics

Locations

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Investigational center

Chandler, Arizona, United States

Site Status

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Phoenix, Arizona, United States

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Anaheim, California, United States

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Culver City, California, United States

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Garden Grove, California, United States

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La Habra, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Newport Beach, California, United States

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Oceanside, California, United States

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Orange, California, United States

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San Bernardino, California, United States

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Torrance, California, United States

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Cromwell, Connecticut, United States

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Hartford, Connecticut, United States

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Hialeah, Florida, United States

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Largo, Florida, United States

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Miami, Florida, United States

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Miami Lakes, Florida, United States

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Orlando, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Augusta, Georgia, United States

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Chicago, Illinois, United States

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Springfield, Illinois, United States

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Warrenville, Illinois, United States

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Marrero, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Flowood, Mississippi, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Marlton, New Jersey, United States

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Cedarhurst, New York, United States

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Glen Oaks, New York, United States

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Click Therapeutics

New York, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Beachwood, Ohio, United States

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Cincinnati, Ohio, United States

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Columbus, Ohio, United States

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Oklahoma City, Oklahoma, United States

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State College, Pennsylvania, United States

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Charleston, South Carolina, United States

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Austin, Texas, United States

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Forth Worth, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

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Mesquite, Texas, United States

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Plano, Texas, United States

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Salt Lake City, Utah, United States

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St. George, Utah, United States

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Countries

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United States

References

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Lakhan SE, Dorner-Ciossek C, Besedina O, Dickerson F, Hastedt C, Isla R, Kahn RS, Lindenmayer JP, Mehta R, Snipes C, Speier A, Tang W, Willis B, Fernandez JW, von der Goltz C, Pratap A. Effectiveness, Engagement, and Safety of a Digital Therapeutic (CT-155/BI 3972080) for Treating Negative Symptoms in People With Schizophrenia: Protocol for the Phase 3 CONVOKE Randomized Controlled Trial. JMIR Res Protoc. 2025 Oct 7;14:e81293. doi: 10.2196/81293.

Reference Type DERIVED
PMID: 41057039 (View on PubMed)

Other Identifiers

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CT-155-R-001

Identifier Type: -

Identifier Source: org_study_id

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