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Tests treatment safety and results for General Anxiety Disorder
Official title Clinical Trial to Evaluate the Efficacy and Safety of the Aurora® Digital Medical Device in Adult Patients With Moderate to Severe Generalized Anxiety Disorder
ClinicalTrials.gov ID: NCT07477990
What this study is testing
What is Pharmacological conventional treatment?
Pharmacological conventional treatment is an investigational medicine, being studied as a potential treatment for general anxiety disorder.
Also referred to as Conventional treatment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join 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 likely can't join 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.
- Having received psychiatric drug treatment within the 6 months prior to inclusion in this protocol, including but not limited to prescription drugs...
- Any clinical or sociodemographic condition that prevents the use of the Aurora® digital medical device as established in this protocol; for example...
See the full eligibility 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.
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Mexico City, Mexico City, Mexico
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mexico City, Mexico City, Mexico. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.