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

This study has been completed.
Sponsor:
Collaborators:
Red Oak Psychiatry Associates, PA
Baylor Health Care System
Information provided by (Responsible Party):
Pamlab, Inc.
ClinicalTrials.gov Identifier:
NCT01001559
First received: October 22, 2009
Last updated: November 25, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Major Depressive Disorder
Drug: L-methylfolate
Drug: Selective serotonin reuptake inhibitor (SSRI)
Drug: Serotonin and norepinephrine reuptake inhibitor (SNRI)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Combination Deplin® and Antidepressant Therapy Compared to Antidepressant Therapy Alone for an Episode of Major Depression- a Retrospective Analysis

Resource links provided by NLM:


Further study details as provided by Pamlab, Inc.:

Primary Outcome Measures:
  • Improvement as Measured by Change in Clinical Global Impression of Severity (CGI-S) Rating From Baseline [ Time Frame: 60 days ] [ Designated as safety issue: No ]

    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:
  • Length of Time to Peak Response, as Determined by the Clinical Global Impression of Severity (CGI-S) Scale [ Time Frame: 60 days ] [ Designated as safety issue: No ]

    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.


  • Number of Hospitalizations Due to MDD [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
    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

  • Absolute Count of Alterations in Therapy Required, Such as Dose Increases, Antidepressant Substitutions, or Addition of Augmentation Medications [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Enrollment: 242
Study Start Date: August 2009
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Deplin + antidepressant
Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
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
Other Name: Deplin
Drug: 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.
Drug: 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.
Antidepressant alone
SSRI or SNRI alone
Drug: 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.
Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adults ages 18-70 experiencing an episode of major depression

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001559

Locations
United States, Texas
Red Oak Psychiatry Associates, PA
Houston, Texas, United States
Sponsors and Collaborators
Pamlab, Inc.
Red Oak Psychiatry Associates, PA
Baylor Health Care System
Investigators
Principal Investigator: Lawrence D Ginsberg, MD Red Oak Psychiatry Associates, PA
  More Information

Publications:
Responsible Party: Pamlab, Inc.
ClinicalTrials.gov Identifier: NCT01001559     History of Changes
Other Study ID Numbers: Pamlab D-005
Study First Received: October 22, 2009
Results First Received: April 19, 2013
Last Updated: November 25, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Pamlab, Inc.:
Depression
Combination therapy
antidepressant
Deplin
folate
methylfolate

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Norepinephrine
Serotonin
Serotonin Uptake Inhibitors
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Cardiovascular Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 11, 2014