An Extension Study of a Second Course of a Digital Therapeutic for the Treatment of Experiential Negative Symptoms of Schizophrenia
Part of paid clinical trials in New York, New York.
- Sponsor
- Click Therapeutics, Inc.
- Study ID
- NCT06067984
- Phase
- PHASE3
- Status
- Completed
Conditions
- Negative Symptoms in Schizophrenia
- Schizophrenia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Study App — DEVICEAn investigational prescription digital therapeutic in the form of a smartphone app.
Study Details
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.
Key Dates
- Start date
- Sep 12, 2023
- Status verified
- Jun 2026
- Primary completion
- Jun 13, 2025
- Completion
- Aug 22, 2025
Study Design
- Enrollment
- 73 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Arm AEvaluate the efficacy and safety of a digital therapeutic as an adjunct treatment to SOC in participants with experiential negative symptoms of schizophrenia.
Primary Outcome Measure
Change in Experiential Negative Symptoms [ Time Frame: Baseline to Week 16 ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Click Therapeutics | New York | New York | 10013 | - |
Find similar trials in New York, NY
By condition
By specialty
By research site
Related Studies
- Efficacy and Safety of Cariprazine in the Treatment of Adolescent Participants (13 to 17 Years of Age) With SchizophreniaPHASE3 · Recruiting · Gedeon Richter Plc. · Culver City, California
- Clozapine for the Prevention of Violence in Schizophrenia: a Randomized Clinical TrialPHASE4 · Recruiting · New York State Psychiatric Institute · Los Angeles, California
- Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I DisorderPHASE3 · Recruiting · Alkermes, Inc. · Dothan, Alabama
- An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of SchizophreniaPHASE3 · Recruiting · Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Phoenix, Arizona