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

Recruiting Phase 3 Interventional Study
General Anxiety Disorder
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
162 (estimated)
Sponsor
Psicofarma, S.A. De C.V. · Industry
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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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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. Exc…
Contacts

MIGUEL RAMIREZ, BACHELOR

+525541427729

miguelramirez@seeclinicos.com

CONTACT

ANGEL COLL, MD

+525526702106

angelmario.coll@seeclinicos.com

CONTACT