Combination Deplin® and Antidepressant Therapy for a Major Depressive Episode (MDE)- a Retrospective Analysis
NCT ID: NCT01001559
Last Updated: 2013-12-19
Study Results
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View full resultsBasic Information
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COMPLETED
242 participants
OBSERVATIONAL
2009-08-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Deplin + antidepressant
Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
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.
Antidepressant alone
SSRI or SNRI alone
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
ALL
No
Sponsors
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Red Oak Psychiatry Associates, PA
UNKNOWN
Baylor Health Care System
OTHER
Pamlab, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lawrence D Ginsberg, MD
Role: PRINCIPAL_INVESTIGATOR
Red Oak Psychiatry Associates, PA
Locations
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Red Oak Psychiatry Associates, PA
Houston, Texas, United States
Countries
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References
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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.
Other Identifiers
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Pamlab D-005
Identifier Type: -
Identifier Source: org_study_id