Study of Two Digital Therapeutics for the Treatment of Experiential Negative Symptoms of Schizophrenia (CONVOKE)
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ClinicalTrials.gov Identifier: NCT05838625 |
Recruitment Status :
Recruiting
First Posted : May 1, 2023
Last Update Posted : May 13, 2024
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Sponsor:
Click Therapeutics, Inc.
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Click Therapeutics, Inc.
Tracking Information | |||||||||
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First Submitted Date ICMJE | April 20, 2023 | ||||||||
First Posted Date ICMJE | May 1, 2023 | ||||||||
Last Update Posted Date | May 13, 2024 | ||||||||
Actual Study Start Date ICMJE | March 31, 2023 | ||||||||
Estimated Primary Completion Date | June 18, 2025 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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)
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Study of Two Digital Therapeutics for the Treatment of Experiential Negative Symptoms of Schizophrenia | ||||||||
Official Title ICMJE | 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 | ||||||||
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. | ||||||||
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 ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Schizophrenia | ||||||||
Intervention ICMJE | Device: Digital Therapeutic
A prescription digital therapeutic in the form of a smartphone app.
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
432 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | July 18, 2025 | ||||||||
Estimated Primary Completion Date | June 18, 2025 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria: A participant will be eligible for entry into the study if all of the following criteria are met:
Exclusion Criteria: A participant will not be eligible for study entry if any of the following criteria are met:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT05838625 | ||||||||
Other Study ID Numbers ICMJE | CT-155-R-001 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||||||
Current Responsible Party | Click Therapeutics, Inc. | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Click Therapeutics, Inc. | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Boehringer Ingelheim | ||||||||
Investigators ICMJE |
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PRS Account | Click Therapeutics, Inc. | ||||||||
Verification Date | May 2024 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |