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
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Men and women aged ≥18 and ≤65 years.
• Diagnosis of generalized anxiety disorder (GAD) based on DSM-5-TR criteria.
• Score ≥10 on the GAD-7 (Generalized Anxiety Disorder Scale) instrument
• That they agree to participate in the study by signing the informed consent form.
Locations
Other Locations
Mexico
Servicios Especializados En Ensayos Clinicos, Seec, Sc
RECRUITING
Mexico City
Contact Information
Primary
MIGUEL RAMIREZ, BACHELOR
miguelramirez@seeclinicos.com
+525541427729
Backup
ANGEL COLL, MD
angelmario.coll@seeclinicos.com
+525526702106
Time Frame
Start Date: 2026-03-29
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 162
Treatments
Experimental: Patients will be using Aurora Digital Therapy plus conventional treatment for anxiety disorder
81 patients will be assigned to experimental arm with therapy digital Aurora + conventional treatment
Active_comparator: 81 Patients will be using conventional treatment for anxiety disorder
Related Therapeutic Areas
Sponsors
Leads: Psicofarma, S.A. De C.V.