NCT07477990

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

Phase III, Randomized, Multicenter, Open-label Clinical Trial to Evaluate the Efficacy and Safety of the Aurora® Digital Medical Device With Conventional Drug Treatment, Compared to Conventional Drug Treatment Alone, in Adult Patients With Moderate to Severe Generalized Anxiety Disorder

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Psicofarma, S.A. De C.V. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• General Anxiety Disorder

Interventions

Type	Name	Description
OTHER	App AURORA (Digital Therapy) + conventional treatment	81 patients using Digital Therapy Aurora + conventional pharmacological treatment for 12 weeks
DRUG	Pharmacological conventional treatment	81 patients using conventional pharmacological treatment for 12 weeks

Timeline

• Start date: 2026-03-29
• Primary completion: 2027-06-29
• Completion: 2027-07-01
• First posted: 2026-03-17
• Last updated: 2026-04-01

Locations

1 site across 1 country: Mexico