The Effects of Microbial Ecosystem Therapeutic-2 on Sleep Disturbances in Individuals with Major Depressive Disorder

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Bromley, Hayley
Depression , Major depressive disorder , Sleep , Sleep disturbance , Microbiome , Gut-brain axis
Objective: The primary objective of this thesis is to evaluate the effects of microbial ecosystem therapeutic-2 (MET-2) in comparison to a placebo on sleep disturbances in individuals with major depressive disorder (MDD) during a 6-week treatment period, with follow-up assessments at 12- and 24-weeks post-treatment. The secondary objectives are to assess changes in mood at the same intervals and to assess any correlations between sleep and mood. Methods: Data from this thesis were derived from the METDA study, a phase 2 double-blind placebo-controlled trial that recruited individuals with MDD in the Kingston and Toronto areas. Participants were randomly assigned to receive either MET-2 or a placebo for 6 weeks. Longitudinal effects of MET-2 were explored in a follow-up sub-study at 12- and 24-weeks post-treatment. The Pittsburgh Sleep Quality Index (PSQI) and the Montgomery Åsberg Depression Rating Scale (MADRS) evaluated changes in sleep and mood, respectively, at each time point. Results: Among the 27 participants included in the analysis of this thesis, a two-way repeated measures ANOVA showed significant improvements in PSQI scores within the MET-2 group (n= 13) compared to the placebo group (n= 14) from baseline to week 6 (p= 0.044) and baseline to week 18 (p= 0.011), after adjusting for sex and age. Although MADRS scores did not display inter-group differences, intra-group trends revealed notable mood improvements in MET-2 recipients from baseline to week 6 (p<0.001) and baseline to week 12 (p= 0.003). Conclusion: This study is the first to examine the potential efficacy of MET-2 in mitigating sleep disturbances in individuals with MDD, suggesting the potential benefits in treating sleep-related symptoms in MDD. The results of this study contribute to a growing body of research on gut repopulation as a treatment method for a variety of psychiatric illnesses, offering new insights and directions for future investigations.
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