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

NCT07477990 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2026-04-01

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Psicofarma, S.A. De C.V.

    lead INDUSTRY

Principal Investigators

  • ANGEL M COLL · SERVICIOS ESPECIALIZADOS EN ENSAYOS CLINICOS, SEEC, SC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-29
Primary Completion
2027-06-29
Completion
2027-07-01

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07477990 on ClinicalTrials.gov