Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07477990
PHASE3

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

Sponsor: Psicofarma, S.A. De C.V.

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

162

Start Date

2026-03-29

Completion Date

2027-07-01

Last Updated

2026-04-01

Healthy Volunteers

No

Interventions

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

Locations (1)

Servicios Especializados En Ensayos Clinicos, Seec, Sc

Mexico City, Mexico City, Mexico