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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT03310827
Eligibility Criteria:
Inclusion Criteria:
1. Male or female subjects who are living in the community and 19 years of age or older.
2. Mild to moderate depression as measured by the Quick Inventory of Depressive Symptomology (QIDS10).
3. A level of understanding sufficient to perform all tests and examinations required by the protocol.
Exclusion Criteria:
1. Investigators and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.
2. Current or lifetime diagnosis of any of the following according to DSM-IV or DSM-5 criteria: Schizophrenia Spectrum and Other Psychotic Disorders, Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder, Delusional Disorder, Psychotic Disorder Not Otherwise Specified, Delirium of any type, Dementia of any type, Amnestic Disorder, any Substance-Induced Disorder, or any Psychotic Disorder due to a General Medical Condition.
3. Alcohol or drug dependence during the previous 12 months. Participants must have consumed less than 10 alcoholic beverages per week in the previous 4 weeks and had no use of marijuana and other illicit drugs. At each visit, participants will be asked for an estimate of their use of each of these substances, and these amounts will be recorded for possible later statistical analysis.
4. Hospitalization for treatment of a mental health condition within the previous 6 months.
5. Serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months. This includes hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic diseases (specifically current agranulocytosis with an absolute neutrophil count \<500 mm3).
6. Indication of treatment resistance (e.g., has been given more than 3 treatments for depression).
7. Not taking any atypical antipsychotics or anti-depressants that have an appetite stimulating effect (e.g., Mirtazapine)
8. Uncorrected hypothyroidism or hyperthyroidism in the previous 12 months.
9. Diagnosed Inflammatory Bowel Syndrome, or any other chronic gastrointestinal problem.
10. Treatment with electroconvulsive therapy (ECT) within previous 6 months.
11. Patients will be excluded temporarily if they have taken an oral antibiotic in the previous 6 weeks. If an antibiotic is begun during the course of the trial, that patient will be withdrawn from the study.
12. Taking any type of nutritional or herbal supplement, including melatonin, known to have a centrally-acting effect. However, participants who have been taking supplements such as Echinacea, chondroitin, or glucosamine may enter the study if a) they have been taking these agents for at least one month prior to the study, and b) they continue on these agents throughout the study. Supplement information will be presented at intake, and the cessation of any such supplements will be required for the participant to continue in screening.
13. Women who are pregnant or breast-feeding; women of childbearing potential who are not using a medically accepted means of contraception when engaging in sexual intercourse (for example, intrauterine device, oral contraceptive, implant, Depo-Provera, or barrier devices with spermicide). Women who become pregnant during the trial will be withdrawn.
14. Any person judged clinically to be at serious risk for suicide or violence.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
50 Years
Study:
NCT03310827
Study Brief:
Protocol Section:
NCT03310827