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 @ 2:51 PM
Ignite Modification Date:
2025-12-24 @ 2:51 PM
NCT ID:
NCT01001559
Eligibility Criteria:
Inclusion Criteria:
* Males or females age 18-70
* The active arm (Arm #1) includes randomly selected 100-125 charts of patients with a primary diagnosis of major depression and a CGI-S of ≥4 who began Deplin and SSRI or SNRI therapy at the same time beginning in January 2007 to the present; and, Control group (Arm #2) includes randomly selected 125-150 charts of patients with a primary diagnosis of major depression who began SSRI or SNRI therapy matched in severity (CGI-S of ≥4)
Exclusion Criteria:
* Folic acid \>400 mcg taken at any time during the study
* Psychotic features in the current episode or a history of psychotic features
* Any bipolar disorder (current or past) or any psychotic disorder (current or past)
* Current or past treatment with vagus nerve stimulation, ECT, or transcranial magnetic stimulation
* Antipsychotic therapy in conjunction with their antidepressant currently or in past 4 weeks
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01001559
Study Brief:
Protocol Section:
NCT01001559