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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01001559
• Other study ID #: Pamlab D-005
• Status: Completed
• Phase: N/A
• First received: October 22, 2009
• Last updated: November 25, 2013
• Start date: August 2009
• Est. completion date: June 2011

Study information

• Verified date: November 2013
• Source: Pamlab, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: June 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• L-methylfolate
Subjects must have been on their respective therapies for a minimum of 60 days. L-methylfolate dosing was 7.5 mg or 15 mg daily
• Selective serotonin reuptake inhibitor (SSRI)
Subject must have been on their respective therapy for a minimum of 60 days. Because this was an observational retrospective analysis, dosing of SSRI/SNRI varied on a per patient basis.
• Serotonin and norepinephrine reuptake inhibitor (SNRI)
Subject must have been on their respective therapy for a minimum of 60 days. Because this was an observational retrospective analysis, dosing of SSRI/SNRI varied on a per patient basis.

Locations

Country	Name	City	State
United States	Red Oak Psychiatry Associates, PA	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Pamlab, Inc.	Baylor Health Care System, Red Oak Psychiatry Associates, PA

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ginsberg LD, Oubre AY, Daoud YA. L-methylfolate Plus SSRI or SNRI from Treatment Initiation Compared to SSRI or SNRI Monotherapy in a Major Depressive Episode. Innov Clin Neurosci. 2011 Jan;8(1):19-28. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline	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.	60 days	No
Secondary	Length of Time to Peak Response, as Determined by the Clinical Global Impression of Severity (CGI-S) Scale	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.	60 days	No
Secondary	Number of Hospitalizations Due to MDD	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	60 days	Yes
Secondary	Absolute Count of Alterations in Therapy Required, Such as Dose Increases, Antidepressant Substitutions, or Addition of Augmentation Medications		60 days	No