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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. ( Pamlab, L.L.C. )
ClinicalTrials.gov Identifier:
NCT01001559
First received: October 22, 2009
Last updated: January 9, 2012
Last verified: December 2009
History of Changes
  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
Major Depressive Disorder

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:

Drug Information available for: Serotonin
U.S. FDA Resources

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 ]

Secondary Outcome Measures:
  • Safety and tolerability as measured by side effects/adverse events, vital signs, and compliance [ Time Frame: 60 days ] [ Designated as safety issue: Yes ]
  • Length of time to peak response [ Time Frame: 60 days ] [ Designated as safety issue: No ]
  • Differences in alterations in therapy required, such as dose increases, antidepressant substitutions, or addition of augmentation medications [ Time Frame: 60 days, 90 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
Deplin + antidepressant
Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
Antidepressant alone
SSRI or SNRI alone

  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
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, L.L.C.
Red Oak Psychiatry Associates, PA
Baylor Health Care System
Investigators
Principal Investigator: Lawrence D Ginsberg, MD Red Oak Psychiatry Associates, PA
  More Information

No publications provided

Responsible Party: Pamlab, Inc. ( Pamlab, L.L.C. )
ClinicalTrials.gov Identifier: NCT01001559     History of Changes
Other Study ID Numbers: Pamlab D-005
Study First Received: October 22, 2009
Last Updated: January 9, 2012
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
Serotonin Uptake Inhibitors
Psychotropic Drugs
 Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013