Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 12:40 AM
NCT ID:
NCT06816667
Eligibility Criteria:
Inclusion Criteria:
* Voluntary participants aged between 40 and 80 years, regardless of sex.
* Must provide written informed consent to participate in the study.
* Participants must exhibit moderate to high levels of anxiety and/or depression:
* Anxiety levels assessed using the State-Trait Anxiety Inventory (STAI):
* STAI-S (State) score of ≥20 for men and ≥23 for women
* STAI-T (Trait) score of ≥20 for men and ≥26 for women
* Depression levels assessed using the Beck Depression Inventory (BDI):
* BDI score of ≥21 indicating the presence of moderate to severe depressive symptoms.
* Participants may meet the criteria for either anxiety, depression, or both, as long as they meet the respective thresholds for each
Exclusion Criteria:
* Liver dysfunction
* Cardiovascular conditions, including: Uncontrolled hypertension, Angina, Clinically significant ECG abnormalities (e.g., atrial fibrillation), Transient ischemic attack (TIA) within the last 6 months.
* Stroke or peripheral/pulmonary vascular disease without active claudication.
* Blood pressure exceeding 140 mmHg systolic or 90 mmHg diastolic.
* Epilepsy or a history of seizures.
* Kidney failure.
* Insulin-dependent diabetes.
* Chronic obstructive pulmonary disease (COPD).
* Increased intracranial or cerebrospinal pressure
* Hyperthyroidism
* Psychotic symptoms or a family history of psychotic disorders
* Prodromal symptoms of schizophrenia or dissociative identity disorder.
* Severe symptoms of depression or anxiety requiring immediate treatment with antidepressants or daily anxiolytic medications, especially in cases involving suicidal ideation.
* Medications: Regular use of prescribed psychoactive medications, such as: Benzodiazepines, Medications affecting serotonin neurons (e.g., ondansetron), Monoamine oxidase inhibitors (MAOIs).
* Drug Interactions: Use of potent metabolic inducers or inhibitors, including: Inducers: Rifampicin (rifabutin, rifapentine), anticonvulsants (carbamazepine, phenytoin, phenobarbital), nevirapine, efavirenz, taxol, dexamethasone. or Inhibitors: All HIV protease inhibitors, itraconazole, ketoconazole, erythromycin, clarithromycin, and troleandomycin.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT06816667
Study Brief:
Protocol Section:
NCT06816667