An Extension Study of a Second Course of a Digital Therapeutic for the Treatment of Experiential Negative Symptoms of Schizophrenia
NCT06067984 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 73
Last updated 2025-10-16
Summary
The purpose of the proposed an open label extension (OLE) study is to evaluate the maintained efficacy and safety of a second consecutive course of Click Therapeutics Study App as an adjunct treatment to standard of care (SOC) in participants who were on the Study App and have recently completed the Click Therapeutics Randomized Clinical Trial NCT05838625.
Conditions
- Schizophrenia
- Negative Symptoms in Schizophrenia
Interventions
- DEVICE
-
Study App
An investigational prescription digital therapeutic in the form of a smartphone app.
Sponsors & Collaborators
- collaborator INDUSTRY
-
Click Therapeutics, Inc.
lead INDUSTRY
Principal Investigators
-
Viveca Livezey, MD · Click Therapeutics
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-09-12
- Primary Completion
- 2025-06-13
- Completion
- 2025-08-22
- FDA Device
- Yes
Countries
- United States
Study Locations
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