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

Completed

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

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Deplin + antidepressant	L-methylfolate	Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
Deplin + antidepressant	Serotonin and norepinephrine reuptake inhibitor (SNRI)	Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
Antidepressant alone	Selective serotonin reuptake inhibitor (SSRI)	SSRI or SNRI alone
Deplin + antidepressant	Selective serotonin reuptake inhibitor (SSRI)	Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
Antidepressant alone	Serotonin and norepinephrine reuptake inhibitor (SNRI)	SSRI or SNRI alone

Primary Outcome Measures

Name	Time	Method
Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline	60 days	The Clinical Global Impression of Severity (CGI-S) Rating evaluates the severity of individual symptoms and treatment response in patients with mental disorders. The CGI-S is a 7-point scale that that requires the clinician to rate the severity of the patient's illness at the time of assessment. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms. Number of patients with an improvement in CGI-S scores as demonstrated by a reduction in ≥2 points (major improvement) from baseline.

Secondary Outcome Measures

Name	Time	Method
Length of Time to Peak Response, as Determined by the Clinical Global Impression of Severity (CGI-S) Scale	60 days	The Clinical Global Impression of Severity (CGI-S) Rating evaluates the severity of individual symptoms and treatment response in patients with mental disorders. The CGI-S is a 7-point scale that that requires the clinician to rate the severity of the patient's illness at the time of assessment. A rating of 1 is considered normal, or with the least severe symptoms, a rating of 7 is extremely ill, or the worst symptoms. Median times to peak response. Peak response defined as the first improvement of two or more in the CGI-S from initial visit, and measured the time to the occurrence.
Absolute Count of Alterations in Therapy Required, Such as Dose Increases, Antidepressant Substitutions, or Addition of Augmentation Medications	60 days
Number of Hospitalizations Due to MDD	60 days	Number of hospitalizations due to MDD during treatment were assessed during this retrospective analysis of L-methylfolate plus SSRI/SNRI at treatment initiation (n=95) and SSRI/SNRI monotherapy (n-147) from patient charts