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

March 31, 2026 updated by: Psicofarma, S.A. De C.V.

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
162

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Mexico
    • Mexico City
      • Mexico City, Mexico City, Mexico, 06500
        • Recruiting
        • Servicios Especializados En Ensayos Clinicos, Seec, Sc
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
GAD-7 scale
Time Frame: 12 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adverse event
Time Frame: 12 weeks
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
12 weeks
Adverse incident
Time Frame: 12 weeks
Number of Participants With Treatment-Related Incident Events as Assessed
12 weeks
Penn State Worry Questionnaire (PSWQ)
Time Frame: 4, 8 and 12 weeks
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)
Time Frame: 4, 8 and 12 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Psicofarma, S.A. De C.V.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: ANGEL M COLL, Servicios Especializados En Ensayos Clinicos, Seec, Sc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 29, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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