Study of Two Digital Therapeutics for the Treatment of Experiential Negative Symptoms of Schizophrenia
CONVOKE
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
1 other identifier
interventional
464
1 country
54
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 schizophrenia
Started Mar 2023
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 31, 2023
CompletedFirst Submitted
Initial submission to the registry
April 20, 2023
CompletedFirst Posted
Study publicly available on registry
May 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 23, 2025
CompletedOctober 16, 2025
October 1, 2025
2.2 years
April 20, 2023
October 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Experiential negative symptoms
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 Outcomes (6)
Motivation and pleasure symptoms
Baseline to Week 8
Expressive negative symptoms
Baseline to Weeks 8 and 16
Positive symptoms
Baseline to Weeks 8 and 16
Social functioning
Baseline to Weeks 8 and 16
Self-reported defeatist beliefs
Baseline to Weeks 8 and 16
- +1 more secondary outcomes
Study Arms (2)
Digital Therapeutic A
EXPERIMENTALEvaluate the efficacy and safety of digital therapeutic A as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia.
Digital Therapeutic B
EXPERIMENTALEvaluate the efficacy and safety of digital therapeutic B as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia.
Interventions
A prescription digital therapeutic in the form of a smartphone app.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Click Therapeutics, Inc.lead
- Boehringer Ingelheimcollaborator
Study Sites (54)
Investigational center
Chandler, Arizona, 85226, United States
Investigational center
Phoenix, Arizona, 85012, United States
Investigational center
Anaheim, California, 92805, United States
Investigational center
Culver City, California, 90230, United States
Investigational center
Garden Grove, California, 92845, United States
Investigational center
La Habra, California, 90631, United States
Investigational center
Long Beach, California, 90807, United States
Investigational center
Los Angeles, California, 90025, United States
Investigational center
Newport Beach, California, 92660, United States
Investigational center
Oceanside, California, 92056, United States
Investigational center
Orange, California, 92868, United States
Investigational center
San Bernardino, California, 92408, United States
Investigational center
Torrance, California, 90504, United States
Investigational center
Cromwell, Connecticut, 06416, United States
Investigational center
Hartford, Connecticut, 06116, United States
Investigational center
Hialeah, Florida, 33016, United States
Investigational center
Largo, Florida, 33777, United States
Investigational center
Miami, Florida, 33156, United States
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Miami Lakes, Florida, 33014, United States
Investigational center
Orlando, Florida, 32803, United States
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West Palm Beach, Florida, 33407, United States
Investigational center
Atlanta, Georgia, 30338, United States
Investigational center
Augusta, Georgia, 30912, United States
Investigational center
Chicago, Illinois, 60611, United States
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Springfield, Illinois, 77030, United States
Investigational center
Warrenville, Illinois, 60555, United States
Investigational center
Marrero, Louisiana, 70072, United States
Investigational center
Baltimore, Maryland, 21204, United States
Investigational center
Boston, Massachusetts, 02131, United States
Investigational center
Flowood, Mississippi, 39232, United States
Investigational center
St Louis, Missouri, 63141, United States
Investigational center
Omaha, Nebraska, 68144, United States
Investigational center
Las Vegas, Nevada, 89124, United States
Investigational center
Marlton, New Jersey, 08054, United States
Investigational center
Cedarhurst, New York, 11516, United States
Investigational center
Glen Oaks, New York, 11004, United States
Click Therapeutics
New York, New York, 10013, United States
Investigational center
New York, New York, 10027, United States
Investigational center
Rochester, New York, 14623, United States
Investigational center
Charlotte, North Carolina, 27608, United States
Investigational center
Beachwood, Ohio, 44122, United States
Investigational center
Cincinnati, Ohio, 45267, United States
Investigational center
Columbus, Ohio, 43210, United States
Investigational center
Oklahoma City, Oklahoma, 73116, United States
Investigational center
State College, Pennsylvania, 16801, United States
Investigational center
Charleston, South Carolina, 29425, United States
Investigational center
Austin, Texas, 78752, United States
Investigational center
Forth Worth, Texas, 76104, United States
Investigational center
Houston, Texas, 77030, United States
Investigational center
Irving, Texas, 75062, United States
Investigational center
Mesquite, Texas, 75149, United States
Investigational center
Plano, Texas, 75093, United States
Investigational center
Salt Lake City, Utah, 84105, United States
Investigational center
St. George, Utah, 84770, United States
Related Publications (1)
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.
PMID: 41057039DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Viveca Livezey, MD
Click Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 20, 2023
First Posted
May 1, 2023
Study Start
March 31, 2023
Primary Completion
June 20, 2025
Study Completion
July 23, 2025
Last Updated
October 16, 2025
Record last verified: 2025-10