Combination Deplin® and Antidepressant Therapy for a Major Depressive Episode (MDE)- a Retrospective Analysis

Completed

Conditions studied: Major Depressive Disorder

In brief

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.

Key facts

Study ID

NCT01001559

Run by

Pamlab, Inc.

People needed

242

Starts

2009-08-01

Expected to finish

2011-06-01

Last updated by the study team

2013-12-19

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Red Oak Psychiatry Associates, PA — Houston, Texas, United States

Full record on ClinicalTrials.gov

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