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| Name | Class |
|---|---|
| National University of Malaysia | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic 9 log CFU/day | Experimental | The intervention consists of daily administration of one sachet/day of probiotic for 12 weeks, where each sachet contains 9 log CFU of probiotic. |
|
| Placebo | Placebo Comparator | placebo contains primarily carrier and without probiotic. The placebo are identical in taste and appearance and appear as a light-yellow powder. |
|
| Acceptance and commitment therapy (ACT) | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Min Tze Liong, Prof.Dr | School of Industrial Technology, University of Science Malaysia | Study Director |
| Luke Woon Sy-Cherng, Dr | Department of Psychiatry Hospital Canselor Tuanku Muhriz UKM medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Canselor Tuanku Muhriz UKM Medical Centre | Cheras | Kuala Lumpur | 56000 | Malaysia |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| D064869 | Acceptance and Commitment Therapy |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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A double-blind three-armed randomized controlled trial design has been chosen. Randomization for the parallel prevention phase will be carried out after checking the inclusion and exclusion criteria
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. The randomization will be performed by the study statistician, who had no contact with the patients and not involve in the research project. The allocation sequence will not be available to any member of the research team until databases had been completed and locked. Since this is a double-blinded study, both the research team and subject will not know in which group the subject is assigned to.
|
| Placebo | Dietary Supplement | 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. |
|
| Acceptance and commitment therapy (ACT) | Behavioral | 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. |
|
| 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. | 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. | 24 weeks |
| D019602 |
| Food and Beverages |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |