Phase 3 Depression and Anxiety Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults between 18 and 65 years of age (inclusive).
• People who have been diagnosed with Generalized Anxiety Disorder (GAD) based on recognised diagnostic standards (DSM-5-TR criteria).
• People whose GAD symptom score on a standard anxiety questionnaire (the GAD-7) is 10 or higher.
• People who are willing to participate and sign a consent form agreeing to take part in the study.

Who may not be able to join:

• People who have a diagnosed alcohol use disorder or a drug use disorder.
• People who consume energy drinks.
• People who consume more than 150 mg of caffeine per day (for reference, a standard cup of coffee contains roughly 80–100 mg).
• People who have a known allergy or sensitivity to escitalopram (Selective®) or duloxetine (Arquera®), or to any ingredient in those medications.
• People who have taken any psychiatric or mental health treatments in the 6 months before joining, including prescription medications such as antidepressants (SSRIs or SNRIs) or anti-anxiety medications (benzodiazepines), herbal remedies, or substances such as cannabis, CBD, microdoses of LSD, ayahuasca, or similar substances. Note: having previously attended psychotherapy, support groups, meditation, or mindfulness groups is not a reason to be excluded, as long as no psychiatric medication was involved.
• People who are unable to use a digital medical device called Aurora® as required by the study — for example, due to severe vision impairment or having no experience using a smartphone or tablet (confirm with trial site).
• People who have other diagnosed mental health conditions, except for certain depressive disorders that are not caused by substances or medications.
• People who are experiencing a psychiatric emergency at the time of assessment, such as psychosis, a manic episode, or risk of harm to themselves or others.
• People who have been diagnosed with, or are suspected to have, bipolar disorder.
• People who have a history of seizures, even if currently taking medication to control them.
• People found to have an abnormal heart rhythm measurement (a prolonged QT interval) on an initial heart trace (ECG) test.
• People who have been previously diagnosed with significant chronic liver disease (Child-Pugh class B or C).
• People who have been previously diagnosed with moderate-to-severe chronic kidney disease (KDIGO stage 3 or higher).
• People who have been diagnosed with severe heart failure (NYHA functional class III or IV).
• People who have been diagnosed with a tumour of the adrenal gland called pheochromocytoma.
• People who have a serious ongoing or degenerative illness that is not well controlled, or that the study doctor considers poses additional risk.
• People who are currently taking certain medications that cannot safely be combined with escitalopram or duloxetine — including (but not limited to) MAOIs, tricyclic antidepressants, certain heart medications, aspirin, cimetidine, beta-blockers, buspirone, digoxin, carbamazepine, lithium, sumatriptan, theophylline, warfarin, vortioxetine, bupropion, mirtazapine, agomelatine, and phentermine (confirm with trial site if uncertain about specific medications).
• People with any other health condition that, in the study doctor's opinion, makes participation unsafe.
• Women who are pregnant or breastfeeding.
• People whose initial blood or laboratory test results are considered clinically concerning by the study doctor.
• People who have taken part in another clinical trial, or received an experimental treatment, within the 90 days before the selection process.
• People who, in the study doctor's opinion, are unlikely to be able to follow the study activities, or whose participation would pose a health risk.
• People who are currently receiving, or were receiving before study entry, cognitive behavioural therapy (CBT).

Important: Always verify eligibility with the trial site directly before applying.