Clinical Trial

Clinical Trial to Evaluate the Efficacy and Safety of the Aurora® Digital Medical Device in Adult Patients With Moderate to Severe Generalized Anxiety Disorder

Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
To evaluate the superiority of cognitive behavioral therapy using the Aurora® digital medical device + conventional drug treatment, compared to conventional drug treatment alone, in reducing anxiety symptoms, as assessed by the change in the GAD-7 scale at 12 weeks of treatment, relative to baseline.
Protocol Amendment History 3 changes
critical Trial status changed: Active, Not Recruiting → Recruiting 2026-04-02
notable Primary completion pushed: 2026-03-15 -> 2027-06-29 2026-04-02
minor Completion pushed: 2027-04-01 -> 2027-07-01 2026-04-02
Trial Details
NCT Number NCT07477990
Lead Sponsor Psicofarma, S.A. De C.V.
Conditions General Anxiety Disorder
Enrollment 162 participants
Start Date 2026-03-29
Primary Completion 2027-06-29 (estimated)
Study Completion 2027-07-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-01