General Anxiety DisorderPhase 3NCT07477990
Clinical Trial to Evaluate the Efficacy and Safety of the Aurora® Digital Medical Device in Adult Patients With Moderate to Severe Generalized Anxiety Disorder
A Phase 3 study testing App AURORA (Digital Therapy) + conventional treatment and Pharmacological conventional treatment in people with General Anxiety Disorder, run by Psicofarma, S.A. De C.V. at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- General Anxiety Disorder
- What is being tested?
- App AURORA (Digital Therapy) + conventional treatment and Pharmacological conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteMexico
- Study dates
- 29 Mar 2026to 1 Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Servicios Especializados En Ensayos Clinicos, Seec, Sc
Mexico City, Mexico City, 06500
ANGEL COLL, MD, +525526702106, angelmario.coll@seeclinicos.com
About this study
Official title: 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.
- Conditions
- General Anxiety Disorder
- Being tested
- App AURORA (Digital Therapy) + conventional treatment, Pharmacological conventional treatment
- 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
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App AURORA (Digital Therapy) + conventional treatmentOther
Also called Digital therapy, Conventional treatment
81 patients using Digital Therapy Aurora + conventional pharmacological treatment for 12 weeks
Pharmacological conventional treatmentDrug
Also called Conventional treatment
81 patients using conventional pharmacological treatment for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: App AURORA (Digital Therapy) + conventional treatment |
| 81 Patients will be using conventional treatment for anxiety disorder | Active comparator | Not described Receives: Drug: Pharmacological conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 4, 8 and 12 weeks
Adverse event
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Measured: 12 weeks
Adverse incident
Number of Participants With Treatment-Related Incident Events as Assessed
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start29 Mar 2026
- Primary completion29 Jun 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Psicofarma, S.A. De C.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ANGEL M COLL, Study director, SERVICIOS ESPECIALIZADOS EN ENSAYOS CLINICOS, SEEC, SC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07477990
- Sponsor's protocol ID
- INNOVA 2024-01
- Other IDs
- 253300410C1001/2025
- Status last verified
- Mar 2026
- First submitted
- 26 Nov 2025
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07477990
- Acronym / sponsor ID
- INNOVA 2024-01
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Psicofarma, S.A. De C.V.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2026 (actual)
- Primary completion
- 29 Jun 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients will be using Aurora Digital Therapy plus conventional treatment for anxiety disorder | Experimental | Other: App AURORA (Digital Therapy) + conventional treatment81 patients will be assigned to experimental arm with therapy digital Aurora + conventional treatment |
| 81 Patients will be using conventional treatment for anxiety disorder | Active comparator | Drug: Pharmacological conventional treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App AURORA (Digital Therapy) + conventional treatmentAlso: Digital therapy, Conventional treatment81 patients using Digital Therapy Aurora + conventional pharmacological treatment for 12 weeks | Other | Patients will be using Aurora Digital Therapy plus conventional treatment for anxiety disorder |
| Pharmacological conventional treatmentAlso: Conventional treatment81 patients using conventional pharmacological treatment for 12 weeks | Drug | 81 Patients will be using conventional treatment for anxiety disorder |
Primary outcome
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
4 secondary outcomes
Penn State Worry Questionnaire (PSWQ)
Time frame: 4, 8 and 12 weeks
PHQ-9 (Patient Health Questionnaire-9)
Time frame: 4, 8 and 12 weeks
Adverse event
Time frame: 12 weeks
Adverse incident
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ANGEL M COLL study director
SERVICIOS ESPECIALIZADOS EN ENSAYOS CLINICOS, SEEC, SC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing App AURORA (Digital Therapy) + conventional treatment and Pharmacological conventional treatment in people with General Anxiety Disorder, run by Psicofarma, S.A. De C.V. at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MIGUEL RAMIREZ, BACHELOR (+525541427729, miguelramirez@seeclinicos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GAD-7 scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.