L-Methylfolate For Bipolar I depressive episodes: An open trial proof-of-concept registry
- Authors
- Nierenbereg, AA[Nierenbereg, Andrew A.]; Montana, R[Montana, Rebecca]; Kinrys, G[Kinrys, Gustavo]; Deckersbach, T[Deckersbach, Thilo]; Dufour, S[Dufour, Steven]; Baek, JH[Baek, Ji Hyun]
- Issue Date
- 1-Jan-2017
- Publisher
- ELSEVIER SCIENCE BV
- Citation
- JOURNAL OF AFFECTIVE DISORDERS, v.207, pp.429 - 433
- Indexed
- SCIE
SSCI
SCOPUS
- Journal Title
- JOURNAL OF AFFECTIVE DISORDERS
- Volume
- 207
- Start Page
- 429
- End Page
- 433
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/30553
- DOI
- 10.1016/j.jad.2016.09.053
- ISSN
- 0165-0327
- 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 15 mg 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.
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- Appears in
Collections - Medicine > Department of Medicine > 1. Journal Articles
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