Combination Deplin® and Antidepressant Therapy for a Major Depressive Episode (MDE)- a Retrospect… (NCT01001559) | Clinical Trial Compass
CompletedNot Applicable
Combination Deplin® and Antidepressant Therapy for a Major Depressive Episode (MDE)- a Retrospective Analysis
United States242 participantsStarted 2009-08
Plain-language summary
This is a retrospective chart review study to determine if Deplin® 7.5mg-15mg combined with an antidepressant is better than an antidepressant alone in adults with major depression.
Who can participate
Age range18 Years – 70 Years
SexALL
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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
What they're measuring
1
Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline