Clinical Trial to Evaluate the Efficacy and Safety of the Aurora® Digital Medical Device in Adult… (NCT07477990) | Clinical Trial Compass
RecruitingPhase 3
Clinical Trial to Evaluate the Efficacy and Safety of the Aurora® Digital Medical Device in Adult Patients With Moderate to Severe Generalized Anxiety Disorder
Mexico162 participantsStarted 2026-03-29
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Exclusion Criteria:
* 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.
* Having received psychiatric drug treatment within the 6 months prior to inclusion in this protocol, including but not limited to prescription drugs such as SSRIs, SNRIs, benzodiazepines, herbal medicines, or unauthorized substances such as cannabis, microdoses of LSD, CBD, ayahuasca, or any other recreational psychotropic substance.
\-- Having received psychotherapy or having been part of support groups, meditation, mindfulness, or equivalent groups will not be grounds for exclusion, provided that this has not been accompanied by medication aimed at modifying any psychiatric disorder.
* Any clinical or sociodemographic condition that prevents the use of the Aurora® digital medical device as established in this protocol; for example, severe visual impairment, complete lack of knowledge about the use of personal electronic devices such as cell phones or tablets, among others.…