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L-methylfolate augmentation of selective serotonin reuptake inhibitors (SSRIS) for major depressive disorder: Results of two randomized, double-blind trials

Published online by Cambridge University Press:  16 April 2020

G. Papakostas ,
R. Shelton ,
J. Zajecka ,
K. Rickels ,
A. Clain ,
L. Baer ,
D. Schoenfeld ,
E. Nelson ,
J. Barbee  and
B. Lydiard
...Show all authors
G. Papakostas
Affiliation:
Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA
R. Shelton
Affiliation:
Vanderbilt University Medical Center, Nashville, TN, USA
J. Zajecka
Affiliation:
Rush University Medical Center, Chicago, IL, USA
K. Rickels
Affiliation:
Psychiatry, Mood & Anxiety Disorders, University of Pennsylvania, Philadelphia, PA, USA
A. Clain
Affiliation:
Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA
L. Baer
Affiliation:
Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA
D. Schoenfeld
Affiliation:
Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA
E. Nelson
Affiliation:
University of Cincinnati Medical Center, Cincinnati, OH, USA
J. Barbee
Affiliation:
Louisiana State University Behavioral Sciences Center, New Orleans, LA, USA
B. Lydiard
Affiliation:
Southeast Health Consultants, Charleston, SC, USA
D. Mischoulon
Affiliation:
Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA
J. Alpert
Affiliation:
Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA
S. Zisook
Affiliation:
University of San Diego VA Medical Center, San Diego, CA, USA
M. Fava
Affiliation:
Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA

Abstract

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Introduction

Two randomized, controlled trials of L-methylfolate augmentation of SSRIs for major depressive disorder (MDD) were conducted using a novel study design (sequential parallel comparison design- SPCD).

Objectives/aims

To evaluate the efficacy of L-methylfolate augmentation using the Hamilton Depression Rating Scale.

Methods

In study one (TRD-1), 148 outpatients with SSRI-resistant MDD were enrolled in a 60-day, SPCD study, divided into two 30-day periods (phases 1 and 2). Patients were randomized 2:3:3 to receive L-methylfolate (7.5mg/d in phase 1, 15mg/d in phase 2), placebo in phase 1 followed by L-methylfolate 7.5mg/d in phase 2, or placebo for both phases. Study two (TRD-2) involved 75 patients and was identical in design to TRD-1 except for the dose of L-methylfolate (15mg only).

Results

In the TRD-1 Study, L-methylfolate 7.5 mg/d was not found to be more effective than placebo. In phase 1 of the TRD-2 Study, 37% of patients on L-methylfolate 15mg/d responded and 18% of placebo patients responded, while in phase 2 among placebo non-responders, the response rates were 28% on L-methylfolate 15mg/d and 9.5% on placebo. When phases 1 and 2 were pooled according to the SPCD model, the difference in response rates was statistically significant in favor of L-methylfolate (p = 0.0399). The rates of spontaneously reported AEs and rates of study discontinuation appear r comparable between L-methylfolate and placebo in both studies. Rates of study discontinuation were also comparable

Conclusions

These studies suggest that L-methylfolate 15 mg/d may be a safe and effective augmentation strategy for inadequate response to SSRIs.

Type
P01-588
Information
European Psychiatry , Volume 26 , Issue S2: Abstracts of the 19th European Congress of Psychiatry , March 2011 , pp. 592
Copyright
Copyright © European Psychiatric Association2011
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