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| ID | Type | Description | Link |
|---|---|---|---|
| TCTR20240621001 | Registry Identifier | Thai Clinical Trials Registry |
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The goal of this clinical trial is to learn if stingless bee honey can be an augmentation supplement in Major Depressive Disorder (MDD) in adults. It will also learn about the adverse effects of the honey. The main questions it aims to answer are:
There is no placebo.
Participants will:
Take stingless bee honey or nothing every day for 2 months Visit the clinic once every 4 weeks for checkups and tests Report adherence and adverse effects of stingless bee honey on a self-reported online questionnaires
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Active Comparator | The participants under intervention group will receive stingless bee honey. At the same time, they will continue treatment as usual, their pharmacological like antidepressants or psychotherapy |
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| Control group | No Intervention | The participants in the control group will not receive stingless bee honey. They will continue treatment as usual, their pharmacological like antidepressants or psychotherapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stingless bee honey | Dietary Supplement | Participants under intervention group will receive 20g of stingless bee honey in a packet form but participants under control group will not receive any stingless bee honey |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive symptoms | Depressive symptoms will be assessed using Beck Depression Inventory Malay-version questionnaire, For total score, no depression (1 - 10); mild to moderate (11 -20); moderate to severe (21 - 30); severe (31 - 40); very severe (41 - 63). | Before intervention, at week 4 during the intervention, at week 8 of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Oxidative stress | Serum malondialdehyde concentrations in blood will be assessed | Before intervention, at week 4 during the intervention, at week 8 of the intervention |
| Brain derived neurotrophic factors, BDNF |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sharifah Zubaidiah | Universiti Sains Malaysia | Study Director |
| Mohd Zulkifli Mustafa | Universiti Sains Malaysia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universiti Sains Malaysia | Kubang Kerian | Kelantan | 16150 | Malaysia |
Raw unprocessed data, without any identifier that could identify patients as individual person such as demographics chacteristics, baseline, week 4 and week 8 primary and secondary outcomes will be shared upon request by others
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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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Serum BDNF concentrations of blood will be assessed
| Before intervention, at week 4 during the intervention, at week 8 of the intervention |
| Verbal learning and memory | Verbal learning and memory will be assessed using Malay version of auditory verbal learning test. The highest of total learning (sum of A1-A5 trial) is 75 score which one words = 1 score and the highest for delayed memory (A7 trial) is 15 score | Before intervention, at week 4 during the intervention, at week 8 of the intervention |
| Serum Interleukin-6 | Serum IL-6 concentrations of blood will be measured using Elisa kit | Before intervention, at week 4 during the intervention, at week 8 of the intervention |