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:
2025-12-24 @ 10:48 PM
Ignite Modification Date:
2025-12-24 @ 10:48 PM
NCT ID:
NCT00421369
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of Major Depressive Episode (MDE) in the context MDD according to DSM-IV criteria, without psychotic features.
2. Hamilton Depression Scale (21 items, HAM-D) total \>16 with item 1 (depressed mood) \>2.
3. Age 18-70 years.
4. Male or female.
5. Competent and willing to give written informed consent.
Exclusion Criteria:
1. Clinical hyper- or hypothyroidism or any other thyroid illness.
2. Neurological or other medical illness that may impact upon the study or limit prescription of the study medications.
3. Significant suicidal risk \[HAM-D item 3 (suicide) \>2\].
4. Comorbidity with any Psychotic Disorder, Bipolar Disorder, Post Traumatic Stress Disorder (PTSD), Eating Disorder.
5. Lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months.
6. Treatment with the antidepressant, sertraline, in current episode.
7. More then one antidepressant trial or any augmentation treatment during current episode.
8. Length of current episode \>12 months
9. Female subjects pregnant or lactating or not using adequate contraception.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00421369
Study Brief:
Protocol Section:
NCT00421369