The purpose of this study is to evaluate the efficacy of oral administration of probiotic at 9 log CFU/day as adjunctive treatment in reducing the severity of depression in female patients with major depressive disorder with treatment-as-usual compared to placebo and ACT via the use of questionnaires.
1. To assess the differences in quality of life among patients on probiotic, placebo and ACT via the use of questionnaire, at 4 timelines (baseline, 6 weeks after starting intervention, 12 weeks after starting intervention, and 24 weeks after starting intervention which is 12 weeks post-termination of intervention). 2. To assess the differences in blood biological markers such as BDNF, TNF-α, IL-6, IL-1β, CRP, and VEGF among patients on probiotic, placebo and ACT via blood biochemical analyses, at 4 timelines (baseline, 6 weeks after starting intervention, 12 weeks after starting intervention, and 24 weeks after starting intervention which is 12 weeks post-termination of intervention). 3. To assess the differences in gut microbiota profiles of patients on probiotic, placebo and ACT via the use of fecal samples, at 3 timelines (baseline, 12 weeks after starting intervention, and 24 weeks after starting intervention which is 12 weeks post-termination of intervention).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
This project aims to evaluate the efficacy of oral administration of probiotic at 9 log CFU/day as adjunctive treatment in reducing the severity depression in female patients with major depressive disorder with treatment-as-usual compared to placebo and ACT via use of questionnaires.
This project aims to evaluate the efficacy of oral administration of probiotic at 9 log CFU/day as adjunctive treatment in reducing the severity depression in female patients with major depressive disorder with treatment-as-usual compared to placebo and ACT via use of questionnaires.
Patients will be provided with ACT for 12 weeks with treatment as usual. The ACT intervention will be conducted in a group of 10 for each session. The ACT modules covered over 12 sessions, 1 hour in each session. The sessions will be held every week.
Hospital Canselor Tuanku Muhriz UKM Medical Centre
Cheras, Kuala Lumpur, Malaysia
differences in severity of depression in patients with major depressive disorder upon consumption of probiotic at 9 log CFU/day compared to placebo and ACT.
To evaluate differences in severity of depression via the use of the Montgomery and Åsberg (MADRS) Depression Rating Scale questionnaire containing 10-items on a 7-point scale with higher scores indicating more severe depression
Time frame: 24 weeks
differences in quality of life in patients with major depressive disorder upon consumption of probiotic at 9 log CFU/day compared to placebo and ACT.
To evaluate differences in quality of life via the use of the RAND-36 questionnaire containing 36-items on a varying point scale including some items with reverse scoring, with higher scores indicating better health status.
Time frame: 24 weeks
differences in blood depression biomarkers in patients with major depressive disorder upon consumption of probiotic at 9 log CFU/day compared to placebo and ACT.
To evaluate differences in depression blood biological markers such as BDNF, TNF-α, IL-6, IL-1β, CRP, and VEGF via measuring concentrations using commercially available ELISA kit.
Time frame: 24 weeks
differences in gut microbiota profiles of patients with major depressive disorder upon consumption of probiotic at 9 log CFU/day compared to placebo and ACT.
To evaluate differences in gut microbiota profiles via microbiota profiling using DNA of fecal samples amplified for bacterial 16S rRNA and analyzed for high-throughput community sequencing.
Time frame: 24 weeks
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