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

Information source: Pamlab, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: L-methylfolate (Drug); Selective serotonin reuptake inhibitor (SSRI) (Drug); Serotonin and norepinephrine reuptake inhibitor (SNRI) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Pamlab, Inc.

Official(s) and/or principal investigator(s):
Lawrence D Ginsberg, MD, Principal Investigator, Affiliation: Red Oak Psychiatry Associates, PA


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.

Clinical Details

Official title: Combination Deplin and Antidepressant Therapy Compared to Antidepressant Therapy Alone for an Episode of Major Depression- a Retrospective Analysis

Study design: Observational Model: Case Control, Time Perspective: Retrospective

Primary outcome: Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline

Secondary outcome:

Length of Time to Peak Response, as Determined by the Clinical Global Impression of Severity (CGI-S) Scale

Number of Hospitalizations Due to MDD

Absolute Count of Alterations in Therapy Required, Such as Dose Increases, Antidepressant Substitutions, or Addition of Augmentation Medications


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


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


- Antipsychotic therapy in conjunction with their antidepressant currently or in past 4


Locations and Contacts

Red Oak Psychiatry Associates, PA, Houston, Texas, United States
Additional Information

Starting date: August 2009
Last updated: November 25, 2013

Page last updated: August 23, 2015

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