A Phase 3 open-label extension study evaluating a second course of a digital therapeutic for the treatment of experiential negative symptoms of Schizophrenia reached its primary completion on 2025-06-13, enrolling 73 participants.
Background
Schizophrenia is a complex, chronic mental health condition characterized by a range of symptoms, including positive symptoms (e.g., hallucinations, delusions), cognitive symptoms (e.g., impaired memory, attention), and negative symptoms. Negative symptoms, such as anhedonia (inability to experience pleasure), avolition (lack of motivation), and alogia (poverty of speech), are particularly challenging to treat and often contribute significantly to functional impairment and poor quality of life for individuals with schizophrenia. Current treatments primarily target positive symptoms, leaving a substantial unmet need for effective interventions for negative symptoms. Digital therapeutics represent an emerging area of treatment, offering software-based interventions to prevent, manage, or treat a medical disorder, often as an adjunct to standard care.
Trial design
This completed study, identified as Phase PHASE3, is an open-label extension (OLE) study designed to evaluate the maintained efficacy and safety of a second consecutive course of the Click Therapeutics Study App. The intervention serves as an adjunct treatment to standard of care (SOC) for participants who had previously completed the Click Therapeutics Randomized Clinical Trial (NCT05838625). The study enrolled 73 participants diagnosed with Schizophrenia and specifically targeting Negative Symptoms in Schizophrenia.
What this means
The primary completion of this Phase 3 open-label extension study signifies that data collection for its primary endpoint has concluded. For patients with schizophrenia, particularly those experiencing persistent negative symptoms, the completion of such a study is a crucial step towards potentially identifying new adjunctive treatment options. The focus on a second course of a digital therapeutic suggests an investigation into the sustained benefits and safety profile over a longer period or with repeated use. Clinicians and patients will await the analysis and publication of these results to understand the maintained efficacy and safety of this digital therapeutic in addressing a challenging aspect of schizophrenia management.
Source
The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for the study NCT06067984, titled "An Extension Study of a Second Course of a Digital Therapeutic for the Treatment of Experiential Negative Symptoms of Schizophrenia", was posted on 2025-06-13 on clinicaltrials.gov.