Study of Two Digital Therapeutics for the Treatment of Experiential Negative Symptoms of Schizophrenia
NCT ID: NCT05838625
Last Updated: 2025-10-16
Study Results
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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COMPLETED
PHASE3
464 participants
INTERVENTIONAL
2023-03-31
2025-07-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
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.
Digital Therapeutic
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.
Digital Therapeutic
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Click Therapeutics, Inc.
INDUSTRY
Responsible Party
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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
Investigational center
Phoenix, Arizona, United States
Investigational center
Anaheim, California, United States
Investigational center
Culver City, California, United States
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Garden Grove, California, United States
Investigational center
La Habra, California, United States
Investigational center
Long Beach, California, United States
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Los Angeles, California, United States
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Newport Beach, California, United States
Investigational center
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
Investigational center
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
Investigational center
Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
Investigational center
Marlton, New Jersey, United States
Investigational center
Cedarhurst, New York, United States
Investigational center
Glen Oaks, New York, United States
Click Therapeutics
New York, New York, United States
Investigational center
New York, New York, United States
Investigational center
Rochester, New York, United States
Investigational center
Charlotte, North Carolina, United States
Investigational center
Beachwood, Ohio, United States
Investigational center
Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
Investigational center
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
Investigational center
Plano, Texas, United States
Investigational center
Salt Lake City, Utah, United States
Investigational center
St. George, Utah, United States
Countries
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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.
Other Identifiers
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CT-155-R-001
Identifier Type: -
Identifier Source: org_study_id
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