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

Phase III, Randomized, Multicenter, Open-label Clinical Trial to Evaluate the Efficacy and Safety of the Aurora® Digital Medical Device With Conventional Drug Treatment, Compared to Conventional Drug Treatment Alone, in Adult Patients With Moderate to Severe Generalized Anxiety Disorder

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.

Study Overview

• Status: Recruiting
• Conditions: General Anxiety Disorder
• Intervention / Treatment: Other: App AURORA (Digital Therapy) + conventional treatment; Drug: Pharmacological conventional treatment

• Study Type: Interventional
• Enrollment (Estimated): 162
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: MIGUEL RAMIREZ, BACHELOR; Phone Number: +525541427729; Email: miguelramirez@seeclinicos.com
• Study Contact Backup: Name: ANGEL COLL, MD; Phone Number: +525526702106; Email: angelmario.coll@seeclinicos.com

Study Locations

• Mexico
  • Mexico City
    • Mexico City, Mexico City, Mexico, 06500
      • Recruiting
      • Servicios Especializados En Ensayos Clinicos, Seec, Sc
      • Contact: ANGEL COLL, MD; Phone Number: +525526702106; Email: angelmario.coll@seeclinicos.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.
• 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.
• Patients requiring concomitant treatment with medications contraindicated with the use of escitalopram (Selective®) or duloxetine (Arquera®), such as the following: monoamine oxidase inhibitors (MAOIs), tricyclic antidepressants, class I antiarrhythmics or sodium channel blockers, acetylsalicylic acid, cimetidine, beta-adrenergic blockers, buspirone, digoxin, carbamazepine, lithium, sumatriptan, theophylline, warfarin, vortioxetine, bupropion, mirtazapine, agomelatine, and phentermine.
• Any other clinical condition that, in the investigator's opinion, contraindicates the use of conventional treatment.
• Pregnant or breastfeeding women.
• Any alteration in laboratory tests that, in the opinion of the Investigator, is considered clinically relevant and represents a risk to the patient.
• Patients who have received or are scheduled to receive any investigational product from another clinical study within 90 days prior to the selection process.
• Patients who, in the investigator's opinion, are unable to comply with the protocol activities or whose inclusion poses a risk to their health.
• Patients who are receiving cognitive behavioral therapy prior to or at the time of study entry.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients will be using Aurora Digital Therapy plus conventional treatment for anxiety disorder; 81 patients will be assigned to experimental arm with therapy digital Aurora + conventional treatment	Other: App AURORA (Digital Therapy) + conventional treatment; 81 patients using Digital Therapy Aurora + conventional pharmacological treatment for 12 weeks; Other Names: Conventional treatment; Digital therapy
Active Comparator: 81 Patients will be using conventional treatment for anxiety disorder	Drug: Pharmacological conventional treatment; 81 patients using conventional pharmacological treatment for 12 weeks; Other Names: Conventional treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse event	Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0	12 weeks
Adverse incident	Number of Participants With Treatment-Related Incident Events as Assessed	12 weeks
Penn State Worry Questionnaire (PSWQ)	Change From Baseline in the Penn State Worry Questionnaire (PSWQ) in week 4, 8 and 12. Changes in the initial versus final PSWQ scale in both treatment arms. Values 16 to 80 points. A decrease in the PSWQ scale signifies patient improvement.	4, 8 and 12 weeks
PHQ-9 (Patient Health Questionnaire-9)	Change From Baseline in PHQ-9 (Patient Health Questionnaire-9) in week 4, 8 and 12 . Changes in the initial versus final PHQ-9 scale in both treatment arms. Values 0 to 27 points. A decrease in the PHQ-9 scale signifies patient improvement.	4, 8 and 12 weeks

Collaborators and Investigators

• Sponsor: Psicofarma, S.A. De C.V.
• Investigators: Study Director: ANGEL M COLL, Servicios Especializados En Ensayos Clinicos, Seec, Sc

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2026
• Primary Completion (Estimated): June 29, 2027
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: November 26, 2025
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 31, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Efficacy and Safety; Phase III; Medical Device; Multicenter study; Generalized anxiety disorder; Aurora Digital Therapy; Pharmacology Conventional Treatment; Add-on Digital Therapeutic General Anxiety Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Generalized Anxiety Disorder
• Other Study ID Numbers: INNOVA 2024-01; 253300410C1001/2025 (Other Identifier: COFEPRIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No