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

Pamlab

Status

Completed

Conditions

Major Depressive Disorder

Treatments

Drug: L-methylfolate

Drug: Serotonin and norepinephrine reuptake inhibitor (SNRI)

Drug: Selective serotonin reuptake inhibitor (SSRI)

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT01001559

Pamlab D-005

Details and patient eligibility

About

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.

Enrollment

242 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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