NCT05838625

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 464 (actual)
• Sponsor: Click Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DEVICE	Digital Therapeutic	A prescription digital therapeutic in the form of a smartphone app.

Timeline

• Start date: 2023-03-31
• Primary completion: 2025-06-20
• Completion: 2025-07-23
• First posted: 2023-05-01
• Last updated: 2025-10-16

Locations

54 sites across 1 country: United States

Regulatory

• FDA-regulated device study