Major Depressive Disorder (MDD)
Conditions
Brief summary
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: 1. Is there any effect of SBH on depressive symptoms between intervention and control groups in MDD? 2. Are there any effects of SBH on BDNF between intervention and control groups in MDD? 3. Are there any effects of SBH on oxidative stress between intervention and control groups in MDD? 4. Are there any effects of SBH on verbal learning and memory between intervention and control groups in MDD? 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
Interventions
DIETARY_SUPPLEMENTstingless bee honey
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
Sponsors
Hospital Universiti Sains Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adults with ages 18 to 65 * with Major Depressive Disorder with scores of Beck Depression Inventory Malay version equal or more than 11
Exclusion criteria
* Women in pregnancy or breast-feeding. * Patients who with honey allergy or stingless bee honey allergy. * Currently taking honey not limited to stingless bee honey or taken honey not limited to stingless bee honey in the past one month. * comorbidity either with generalized anxiety disorder, * panic disorder, * social anxiety disorder, * bipolar disorder, * substance-use disorder, * suicidal ideation or attempt, * dementia, * Alzheimer disease, * diabetic, * hypertension, * chronic kidney disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive symptoms | Before intervention, at week 4 during the intervention, at week 8 of the intervention | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxidative stress | Before intervention, at week 4 during the intervention, at week 8 of the intervention | Serum malondialdehyde concentrations in blood will be assessed |
| Brain derived neurotrophic factors, BDNF | Before intervention, at week 4 during the intervention, at week 8 of the intervention | Serum BDNF concentrations of blood will be assessed |
| Verbal learning and memory | Before intervention, at week 4 during the intervention, at week 8 of the intervention | 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 |
| Serum Interleukin-6 | Before intervention, at week 4 during the intervention, at week 8 of the intervention | Serum IL-6 concentrations of blood will be measured using Elisa kit |
Countries
Malaysia
Outcome results
None listed