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 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT01114334
Eligibility Criteria:
Inclusion Criteria:
1. Women and men aged 18 or older presenting at one of the seven DHH study clinics with a new treatment episode for depression will be considered for the study.
2. The PHQ-9 is used to define depression category with a sensitivity and specificity for MDD of at least 88%. Patients must have PHQ-9≥10 to ensure sufficient severity to warrant intervention.
3. A new treatment episode is defined as no treatment with an antidepressant medication for emotional problems over the previous 90 days, nor evidence-based psychotherapy for depression.
4. The subjects must have major depression as determined by diagnostic schedule.
Exclusion Criteria:
1. Receipt of an antidepressant medication in the previous 90 days other than a low-dose TCA for pain or Trazodone for sleep (e.g. amitriptyline ≤ 50 mg a day or Trazodone ≤ 100 mg at night).
2. Current interpersonal or cognitive behavioral psychotherapy that focuses on depression.
3. Female subjects who are either pregnant or nursing.
4. Subjects with drug or alcohol dependency or abuse (except for nicotine or caffeine) within the preceding 6 months.
5. High risk for suicide.
6. Inability to communicate in English.
7. No personal telephone or homeless.
8. Lifetime bipolar disorder.
9. Psychosis.
10. Subjects with a lifetime history of autism, mental retardation, or pervasive developmental disorders.
11. Subjects with uncorrected hypothyroidism or hyperthyroidism.
12. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01114334
Study Brief:
Protocol Section:
NCT01114334