Aurora® digital CBT plus medication for adults 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

This trial tries Aurora® digital cognitive behavioral therapy together with usual medication to see if it reduces anxiety more than medication alone for adults with generalized anxiety disorder.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 162 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Psicofarma, S.A. De C.V. (Industry-sponsored)
• Locations: 1 site (Mexico City, Mexico City)
• Trial ID: NCT07477990 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional study compares the Aurora® digital CBT program plus conventional pharmacological treatment to conventional drug treatment alone in adults aged 18–65 with moderate to severe generalized anxiety disorder. Eligible participants must have a GAD-7 score of 10 or higher at baseline and will receive 12 weeks of treatment with the primary outcome being change in GAD-7 score from baseline to week 12. Major exclusions include active alcohol or recreational drug disorders, excessive caffeine or energy drink use, known hypersensitivity to escitalopram or duloxetine, and any psychiatric medication or psychotherapy in the prior six months. The trial is sponsored by Psicofarma and conducted at a clinical research site in Mexico City.

Who should consider this trial

Good fit: Adults 18–65 with a DSM‑5‑TR diagnosis of generalized anxiety disorder and a GAD‑7 score of 10 or higher who can attend the Mexico City site and commit to 12 weeks of treatment are ideal candidates.

Not a fit: Patients with active substance use disorders, excessive caffeine or energy drink consumption, recent psychiatric medication or psychotherapy, or known hypersensitivity to escitalopram or duloxetine are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, adding Aurora® digital CBT to standard medication could reduce anxiety symptoms more than medication alone.

How similar studies have performed: App-based and digital CBT programs have shown benefit for anxiety in prior studies, but device-specific Phase 3 evidence for Aurora® is limited.

Eligibility criteria

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.

Where this trial is running

Mexico City, Mexico City

• Servicios Especializados En Ensayos Clinicos, Seec, Sc — Mexico City, Mexico City, Mexico (Recruiting)

Study contacts

• Study coordinator: Miguel Ramirez, Bachelor

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