Document Detail


L-methylfolate as adjunctive therapy for SSRI-resistant major depression: results of two randomized, double-blind, parallel-sequential trials.
MedLine Citation:
PMID:  23212058     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: The authors conducted two multicenter sequential parallel comparison design trials to investigate the effect of L-methylfolate augmentation in the treatment of major depressive disorder in patients who had a partial response or no response to selective serotonin reuptake inhibitors (SSRIs).
METHOD: In the first trial, 148 outpatients with SSRI-resistant major depressive disorder were enrolled in a 60-day study divided into two 30-day periods. Patients were randomly assigned, in a 2:3:3 ratio, to receive L-methylfolate for 60 days (7.5 mg/day for 30 days followed by 15 mg/day for 30 days), placebo for 30 days followed by L-methylfolate (7.5 mg/day) for 30 days, or placebo for 60 days. SSRI dosages were kept constant throughout the study. In the second trial, with 75 patients, the design was identical to the first, except that the l-methylfolate dosage was 15 mg/day during both 30-day periods.
RESULTS: In the first trial, no significant difference was observed in outcomes between the treatment groups. In the second trial, adjunctive L-methylfolate at 15 mg/day showed significantly greater efficacy compared with continued SSRI therapy plus placebo on both primary outcome measures (response rate and degree of change in depression symptom score) and two secondary outcome measures of symptom severity. The number needed to treat for response was approximately six in favor of adjunctive L-methylfolate at 15 mg/day. L-Methylfolate was well tolerated, with rates of adverse events no different from those reported with placebo.
CONCLUSIONS: Adjunctive L-methylfolate at 15 mg/day may constitute an effective, safe, and relatively well tolerated treatment strategy for patients with major depressive disorder who have a partial response or no response to SSRIs.
Authors:
George I Papakostas; Richard C Shelton; John M Zajecka; Bijan Etemad; Karl Rickels; Alisabet Clain; Lee Baer; Elizabeth D Dalton; Garret R Sacco; David Schoenfeld; Michael Pencina; Allison Meisner; Teodoro Bottiglieri; Erik Nelson; David Mischoulon; Jonathan E Alpert; James G Barbee; Sidney Zisook; Maurizio Fava
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Publication Detail:
Type:  Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  The American journal of psychiatry     Volume:  169     ISSN:  1535-7228     ISO Abbreviation:  Am J Psychiatry     Publication Date:  2012 Dec 
Date Detail:
Created Date:  2012-12-05     Completed Date:  2013-02-01     Revised Date:  2014-11-14    
Medline Journal Info:
Nlm Unique ID:  0370512     Medline TA:  Am J Psychiatry     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1267-74     Citation Subset:  AIM; IM    
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00321152;  NCT00955955
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MeSH Terms
Descriptor/Qualifier:
Chemotherapy, Adjuvant
Depressive Disorder, Major / drug therapy*
Dose-Response Relationship, Drug
Double-Blind Method
Drug Therapy, Combination
Female
Humans
Male
Middle Aged
Psychiatric Status Rating Scales
Serotonin Uptake Inhibitors / administration & dosage,  therapeutic use*
Tetrahydrofolates / administration & dosage,  therapeutic use*
Treatment Outcome
Chemical
Reg. No./Substance:
0/Serotonin Uptake Inhibitors; 0/Tetrahydrofolates; 134-35-0/5-methyltetrahydrofolate
Comments/Corrections
Comment In:
Evid Based Ment Health. 2013 Aug;16(3):75   [PMID:  23625145 ]
Am J Psychiatry. 2012 Dec;169(12):1223-5   [PMID:  23212050 ]
Fortschr Neurol Psychiatr. 2013 Jul;81(7):366   [PMID:  24015421 ]
Am J Psychiatry. 2013 May;170(5):560   [PMID:  23632839 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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