Actively Recruiting
Clinical Trial to Evaluate the Efficacy and Safety of the Aurora® Digital Medical Device in Adult Patients With Moderate to Severe Generalized Anxiety Disorder
Led by Psicofarma, S.A. De C.V. · Updated on 2026-04-01
162
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Clinical Trial to Evaluate the Efficacy and Safety of the Aurora® Digital Medical Device in Adult Patients With Moderate to Severe Generalized Anxiety Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 2 and 2 65 years
- Diagnosis of generalized anxiety disorder (GAD) based on DSM-5-TR criteria
- Score 2 10 on the GAD-7 anxiety scale
- Agree to participate by signing informed consent
You will not qualify if you...
- Alcohol use disorder or recreational drug use disorder
- Use of energy drinks
- Excessive caffeine intake (over 150 mg per day)
- Hypersensitivity to escitalopram or duloxetine or their components
- Psychiatric drug treatment within 6 months prior to study
- Severe visual impairment or inability to use digital devices
- Other psychiatric disorders except non-substance-induced depression
- Current psychiatric emergencies
- Bipolar disorder diagnosis or suspicion
- History of seizures
- Prolonged QT interval on ECG
- Chronic liver failure (Child-Pugh B or C)
- Chronic kidney disease stage 3 or higher
- Severe heart failure (NYHA class III/IV)
- Diagnosis of pheochromocytoma
- Acute or chronic degenerative diseases posing additional risk
- Use of medications contraindicated with study drugs
- Any condition contraindicating conventional treatment
- Pregnant or breastfeeding women
- Clinically relevant abnormal lab tests
- Participation in another clinical study within 90 days
- Inability to comply with study protocol or health risks
- Receiving cognitive behavioral therapy before or at study entry
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Servicios Especializados En Ensayos Clinicos, Seec, Sc
Mexico City, Mexico City, Mexico, 06500
Actively Recruiting
Research Team
M
MIGUEL RAMIREZ, BACHELOR
CONTACT
A
ANGEL COLL, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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