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

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pamlab, Inc.
• Collaborators: Baylor Health Care System; Red Oak Psychiatry Associates, PA
• Treatments: Antidepressive Agents; Norepinephrine; Serotonin; Serotonin and Noradrenaline Reuptake Inhibitors; Serotonin Uptake Inhibitors

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