Stingless Bee Honey Augmentation in Major Depressive Disorders: A Randomized Clinical Trial

Not Applicable

Not yet recruiting

• Conditions: Major Depressive Disorder (MDD)

• Registration Number: NCT06723249
• Lead Sponsor: Hospital Universiti Sains Malaysia

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-06
• Last Update Submitted: 2024-12-06
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Study Start: 2025-01-01
• Primary Completion: 2025-02-28
• Study Completion: 2025-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Adults with ages 18 to 65 with Major Depressive Disorder 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. Patients with Major Depressive Disorder 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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