General Anxiety Disorder
Conditions
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
Brief 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.
Interventions
OTHERApp AURORA (Digital Therapy) + conventional treatment
81 patients using Digital Therapy Aurora + conventional pharmacological treatment for 12 weeks
DRUGPharmacological conventional treatment
81 patients using conventional pharmacological treatment for 12 weeks
Sponsors
Psicofarma, S.A. De C.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GAD-7 scale | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Penn State Worry Questionnaire (PSWQ) | 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. |
| PHQ-9 (Patient Health Questionnaire-9) | 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. |
| Adverse event | 12 weeks | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 |
| Adverse incident | 12 weeks | Number of Participants With Treatment-Related Incident Events as Assessed |
Countries
Mexico
Contacts
CONTACTMIGUEL RAMIREZ, BACHELOR
CONTACTANGEL COLL, MD
STUDY_DIRECTORANGEL M COLL
SERVICIOS ESPECIALIZADOS EN ENSAYOS CLINICOS, SEEC, SC
Outcome results
None listed