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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Nutraceuticals for major depressive disorder- more is not merrier: An 8-week double-blind, randomised, controlled trial
Journal of Affective Disorders, Volume 245, Year 2019
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Description
Background: One of the most pressing questions in “Nutritional Psychiatry” is whether using combinations of different nutraceuticals with putative antidepressant activity may provide an enhanced synergistic antidepressant effect. Methods: A phase II/III, Australian multi-site, 8-week, double-blind, RCT involving 158 outpatients with a DSM-5 diagnosis of MDD. The intervention consisted of a nutraceutical combination: S-adenosyl methionine; Folinic acid; Omega-3 fatty acids; 5-HTP, Zinc picolinate, and relevant co-factors versus placebo. The primary outcome was change in MADRS score. Hypothesis-driven analyses of potential moderators of response involving key SNPs, and BDNF were also conducted. Results: Placebo was superior to the nutraceutical combination in reducing MADRS score (differential reduction -1.75 points), however a mixed linear model revealed a non-significant Group X Time interaction (p = 0.33). Response rates were 40% for the active intervention and 51% for the placebo; remission rates were 34% and 43% for active and placebo groups, respectively. No significant differences were found between groups on any other secondary depression, anxiety, psychosocial, or sleep outcome measures. Key SNPs and BDNF did not significantly moderate response. No significant differences occurred between groups for total adverse effects, aside from more nausea in the active group. Limitations: Very high placebo response rates suggest a placebo run-in design may have been valuable. Interpretation: The adoption of a nutraceutical 'shotgun’ approach to treating MDD was not supported, and appeared to be less effective than adding placebo to treatment as usual. © 2018 Elsevier B.V.
Authors & Co-Authors
Sarris, Jerome
Australia, Penrith
Western Sydney University
Australia, Melbourne
University of Melbourne
Stough, Con K.K.
Australia, Hawthorn
Swinburne University of Technology
Bousman, Chad A.
Canada, Calgary
University of Calgary
Australia, Melbourne
University of Melbourne
Mischoulon, David
United States, Boston
Harvard Medical School
Cribb, Lachlan
Australia, Melbourne
University of Melbourne
Berk, Michael
Australia, Melbourne
University of Melbourne
Australia, Geelong
Barwon Health
Australia, Melbourne
The Florey
Australia, Melbourne
Orygen Youth Health
Ng, Chee H.
Australia, Melbourne
University of Melbourne
Statistics
Citations: 35
Authors: 7
Affiliations: 9
Identifiers
Doi:
10.1016/j.jad.2018.11.092
ISSN:
01650327
Research Areas
Disability
Mental Health
Study Design
Randomised Control Trial
Study Approach
Quantitative