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J Affect Disord. 2017 Jan 1;207:429-433. doi: 10.1016/j.jad.2016.09.053. Epub 2016 Oct 1.

L-Methylfolate For Bipolar I depressive episodes: An open trial proof-of-concept registry.

Author information

1
Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA. Electronic address: anierenberg@partners.org.
2
Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.
3
Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA.
4
Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA; Department of Psychiatry, Samsung Medical Center, Seoul, Korea.

Abstract

BACKGROUND:

L-methylfolate is a compelling candidate to treat bipolar I major depressive episodes. While approved as an adjunct for unipolar major depressive disorder, no studies have been done to assess the tolerability, safety, and efficacy of L-methylfolate for bipolar depression. As a first step, we developed a registry of bipolar patients treated with L-methylfolate to examine tolerability and outcomes.

METHODS:

Subjects (N=10) received treatment as usual plus daily L-methylfolate 15mg for 6 weeks in this open-label registry. Depressive symptoms were assessed with the Montgomery Asberg Depression Rating Scale (MADRS) and manic symptoms with the Young Mania Rating Scale (YMRS). Effect size was measured with Cohen's d to provide an estimate of potential efficacy.

RESULTS:

The pre-treatment mean (SD) MADRS score was 23.4 (4.34); the post-treatment score was 13.9 (8.24). Cohen's d was 1.19. At post-treatment, 6/10 patients had at least 50% MADRS improvement, and 4/10 patients exhibited remission with MADRS≤10. The pre-treatment YMRS score was 3.2 (3.0); the post-treatment score was 2.7 (5.2). Cohen's d was 0.17.

LIMITATIONS:

This registry was a small open-label clinical trial for a fluctuating disorder. We cannot rule out that our results are due to regression to the mean. A controlled trial is warranted.

CONCLUSIONS:

This first proof-of-concept open registry suggests that L-methylfolate in combination with treatment as usual has potential to treat bipolar depression.

KEYWORDS:

Bipolar disorder; Deplin; Depression; L-methylfolate

PMID:
27794238
DOI:
10.1016/j.jad.2016.09.053
[Indexed for MEDLINE]

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