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 | Recruiting Phase 3

• 2 other identifiers: INNOVA 2024-01253300410C1001/2025
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Generalized anxiety disorder; Aurora Digital Therapy; Medical Device; Pharmacology Conventional Treatment; Multicenter study; Phase III; Efficacy and Safety; Add-on Digital Therapeutic General Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• GAD-7 scale

  Changes in the initial versus final GAD-7 scale in both treatment arms. Values 0 to 21 points. A decrease in the GAD 7 scale signifies patient improvement

  12 weeks

Secondary Outcomes (4)

• Penn State Worry Questionnaire (PSWQ)

  4, 8 and 12 weeks

• PHQ-9 (Patient Health Questionnaire-9)

  4, 8 and 12 weeks

• Adverse event

  12 weeks

• Adverse incident

  12 weeks

Study Arms (2)

Patients will be using Aurora Digital Therapy plus conventional treatment for anxiety disorder

EXPERIMENTAL

81 patients will be assigned to experimental arm with therapy digital Aurora + conventional treatment

Other: App AURORA (Digital Therapy) + conventional treatment

81 Patients will be using conventional treatment for anxiety disorder

ACTIVE COMPARATOR

Drug: Pharmacological conventional treatment

Interventions

App AURORA (Digital Therapy) + conventional treatment OTHER

81 patients using Digital Therapy Aurora + conventional pharmacological treatment for 12 weeks

Also known as: Digital therapy, Conventional treatment

Patients will be using Aurora Digital Therapy plus conventional treatment for anxiety disorder

Pharmacological conventional treatment DRUG

81 patients using conventional pharmacological treatment for 12 weeks

Also known as: Conventional treatment

81 Patients will be using conventional treatment for anxiety disorder

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Presence of other psychiatric comorbidities, with the exception of depressive disorders not induced by substances or medications.
• Patients who, at the time of the selection assessment, present any psychiatric emergency (psychosis, catatonia, manic episode, risk of self-harm or harm to others, etc.).
• Diagnosis or suspicion of bipolar disorder.
• History of seizures, even while undergoing anti-seizure treatment.
• Identification of prolonged QT interval length on the initial assessment electrocardiogram.
• Previous diagnosis of chronic liver failure, Child-Pugh class B or C.
• Previous diagnosis of chronic kidney disease stage KDIGO 3 or higher.
• Diagnosis of NYHA functional class III/IV heart failure.
• Diagnosis of pheochromocytoma.
• Diagnosis of acute or chronic degenerative diseases that are not included in control targets, or that, in the investigator's opinion, represent an additional risk to the patient.

Sponsors & Collaborators

• Psicofarma, S.A. De C.V.: lead

Study Sites (1)

Servicios Especializados En Ensayos Clinicos, Seec, Sc

Mexico City, Mexico City, 06500, Mexico

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• ANGEL M COLL

  SERVICIOS ESPECIALIZADOS EN ENSAYOS CLINICOS, SEEC, SC

  STUDY DIRECTOR

Central Study Contacts

MIGUEL RAMIREZ, BACHELOR

CONTACT

+525541427729; miguelramirez@seeclinicos.com

ANGEL COLL, MD

CONTACT

+525526702106; angelmario.coll@seeclinicos.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: March 17, 2026
• Study Start: March 29, 2026
• Primary Completion (Estimated): June 29, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: April 1, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)