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.

Shaheen E Lakhan¹, Cornelia Dorner-Ciossek², Olya Besedina¹, Faith Dickerson³, Claudia Hastedt², Ridwana Isla⁴, René S Kahn⁵, Jean-Pierre Lindenmayer⁶, Ruchi Mehta¹, Cassandra Snipes¹, Austin Speier¹, Wenbo Tang⁴, Bailey Willis¹, Jamie Winderbaum Fernandez⁷, Christoph von der Goltz², Abhishek Pratap⁴

¹Click Therapeutics Inc, New York, NY, United States.

²Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.

³Sheppard Pratt Health System, Towson, MD, United States.

⁴Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT, United States.

⁵Icahn School of Medicine at Mount Sinai, New York, NY, United States.

⁶Department of Psychiatry, New York University, New York, NY, United States.

⁷IPTB Clinical Research, Tampa, FL, United States.

PubMed PMC DOI PDF

Abstract

BACKGROUND: Negative symptoms of schizophrenia, such as lack of motivation, pleasure, social interest, and expression, are key contributors to functional impairments in people with schizophrenia. While psychosocial interventions have demonstrated efficacy, no Food and Drug Administration-approved pharmacotherapies exist specifically to target these symptoms. Evidence-based digital therapeutics (DT…

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Mentioned Companies

Click Therapeutics
affiliation

MeSH Terms

Humans0Schizophrenia*Double-Blind Method0Antipsychotic Agents0Adult0Male0Female0Smartphone0Treatment Outcome0Mobile Applications*Middle Aged0Schizophrenic Psychology0Clinical Trials, Phase III as Topic0Randomized Controlled Trials as Topic0

Keywords

digital controldigital therapeuticsnegative symptomspatient-centricitypsychosocial interventionrandomized clinical trialschizophreniasmartphone

Article Info

PMID: 41057039
PMCID: PMC12541272
DOI: 10.2196/81293
Received: July 25, 2025
Accepted: September 9, 2025

How to Cite

Lakhan SE et al. 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 Protoc2025;14e81293. doi:10.2196/81293

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