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

NCT01001559 | Completed Results

• 1 other identifier: Pamlab D-005
• Study Type: observational
• Target: 242
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Depression; Combination therapy; antidepressant; Deplin; folate; methylfolate

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

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

  60 days

• Number of Hospitalizations Due to MDD

  60 days

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

  60 days

Study Arms (2)

Deplin + antidepressant

Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)

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

Antidepressant alone

SSRI or SNRI alone

Drug: Selective serotonin reuptake inhibitor (SSRI); Drug: Serotonin and norepinephrine reuptake inhibitor (SNRI)

Interventions

L-methylfolate DRUG

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

Also known as: Deplin

Deplin + antidepressant

Selective serotonin reuptake inhibitor (SSRI) DRUG

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.

Antidepressant alone; Deplin + antidepressant

Serotonin and norepinephrine reuptake inhibitor (SNRI) DRUG

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.

Antidepressant alone; Deplin + antidepressant

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults ages 18-70 experiencing an episode of major depression

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamlab, Inc.: lead
• Red Oak Psychiatry Associates, PA: collaborator
• Baylor Health Care System: collaborator

Study Sites (1)

Red Oak Psychiatry Associates, PA

Houston, Texas, United States

Location

Related 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.

  PMID: 21311704 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

5-methyltetrahydrofolate; Selective Serotonin Reuptake Inhibitors; Serotonin and Noradrenaline Reuptake Inhibitors

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs

Results Point of Contact

• Title: Dr. Lawrence Ginsberg
• Organization: Red Oak Psychiatry Associates

larrydg@earthlink.net

281-893-4111

Study Officials

• Lawrence D Ginsberg, MD

  Red Oak Psychiatry Associates, PA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2009
• First Posted: October 26, 2009
• Study Start: August 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: June 1, 2011
• Last Updated: December 19, 2013
• Results First Posted: December 19, 2013

Record last verified: 2013-11

Locations

US (1)