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 old (any sex) who are being seen as outpatients (not admitted to hospital)
• People who have been diagnosed with Generalised Anxiety Disorder (GAD) according to standard diagnostic guidelines, confirmed by a specific structured interview
• People whose anxiety disorder requires treatment with psychiatric medication
• People whose anxiety and depression symptom scores fall within specific ranges on standard rating scales at both the screening and baseline visits (confirm with trial site for exact score requirements)
• People who are able to understand the trial and are willing to take part, and who have signed a consent form

Who may not be able to join:

• People who currently have a serious risk of suicide, or who score at a certain level on the suicide question of a standard depression rating scale
• People whose depression symptom scores on a standard rating scale are above a certain threshold
• People whose anxiety scores improved by 20% or more between the screening visit and the baseline visit
• People who meet the diagnostic criteria for any other mental health condition besides GAD
• People with a past history of depression, obsessive-compulsive disorder, bipolar disorder, psychotic disorders, factitious disorder, or somatoform disorder, or who have a severe personality disorder (particularly antisocial, borderline, or histrionic type) that the investigator believes would affect their ability to follow the study requirements
• People who have misused or been dependent on alcohol or drugs in the 180 days before screening
• People with a serious or unstable physical health condition affecting the heart, kidneys, lungs, hormonal system (including thyroid problems), digestive system, blood, nervous system, or who have cancer
• People whose physical examination or vital signs showed important abnormal results, such as poorly controlled high blood pressure above certain levels
• People with a history of epilepsy or any condition that may cause seizures (childhood febrile convulsions are an exception)
• People with important abnormal results on blood tests during screening, such as signs of liver or kidney problems above certain levels
• People with certain abnormal heart rhythm findings on an ECG, or other heart-related concerns as determined by the investigator
• People who have had psychiatric surgery, electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) in the 90 days before screening
• People who have been treated with a type of blood pressure or heart medication called beta-blockers in the 90 days before screening
• People with a history of serious allergic reactions, or who are known to be allergic to at least two different medications (including sensitivity to light)
• People who have previously tried two or more antidepressants and/or benzodiazepine medications at appropriate doses for at least four weeks without benefit
• People who have been receiving structured talking therapy or other non-medication treatments (such as acupuncture, hypnosis, or light therapy) in the six weeks before the baseline visit
• People who have recently used certain short-acting anti-anxiety medications (such as lorazepam or alprazolam) or longer-acting ones (such as diazepam or clonazepam), or sleeping tablets called barbiturates, within specific timeframes before screening (confirm exact timeframes with trial site)
• People who have been treated with a class of antidepressant called monoamine oxidase inhibitors (MAOIs) in the period around screening, or with fluoxetine in the 30 days before screening
• People who have recently used antipsychotics, antidepressants, or mood-stabilising medications and have not had a sufficient washout period before the baseline visit (confirm with trial site)
• People who have used certain traditional Chinese medicines, melatonin, or St. John's Wort within three days before the baseline visit
• People who are unable to avoid eating grapefruit or drinking grapefruit juice during the trial and in the seven days before it begins
• Women who are pregnant or breastfeeding, or people (including men) who are planning to have children and are not using reliable contraception during the trial
• People who are unable to take medication as directed
• People who have taken part in another clinical trial within the 90 days before screening
• People who have any other condition that the investigator believes makes them unsuitable for the trial

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