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

ConditionGeneral Anxiety Disorder
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorPsicofarma, S.A. De C.V.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • App AURORA (Digital Therapy) + conventional treatment

    Other intervention

    81 patients using Digital Therapy Aurora + conventional pharmacological treatment for 12 weeks

  • Pharmacological conventional treatment

    Drug

    81 patients using conventional pharmacological treatment for 12 weeks

Treatment groups

162 Participants
are divided into 2 treatment groups
Group A: Patients will be using Aurora Digital Therapy plus conventional treatment for anxiety disorderExperimental treatment 1 intervention
Group B: 81 Patients will be using conventional treatment for anxiety disorderActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
12 weeks

Secondary outcomes

1

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.

Time frame
4, 8 and 12 weeks
2

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.

Time frame
4, 8 and 12 weeks
3

Adverse event

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0

Time frame
12 weeks
4

Adverse incident

Number of Participants With Treatment-Related Incident Events as Assessed

Time frame
12 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Psicofarma, S.A. De C.V.

Lead sponsor

Source ClinicalTrials.gov
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