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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPsicofarma, S.A. De C.V.

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Concomitant alcohol use disorder or recreational drug use disorder.

Consumption of energy drinks.

Excessive caffeine consumption (more than 150 mg per day).

Patients with hypersensitivity to escitalopram (Selective®) or duloxetine (Arquera®) and/or any component of the formulation.

Trial design

Treatments tested in this trial

  • App AURORA (Digital Therapy) + conventional treatment
  • Pharmacological conventional treatment

Treatment groups

162 Participants
are divided into 2 treatment groups

Sponsors and collaborators