Stingless Bee Honey Augmentation in Major Depressive Disorders

NCT06723249 | Completed

• 2 other identifiers: USM/JEPeM/KK/24020180TCTR20240621001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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. 1.Is there any effect of SBH on depressive symptoms between intervention and control groups in MDD?
2. 2.Are there any effects of SBH on BDNF between intervention and control groups in MDD?
3. 3.Are there any effects of SBH on oxidative stress between intervention and control groups in MDD?
4. 4.Are there any effects of SBH on verbal learning and memory between intervention and control groups in MDD?

Conditions

Major Depressive Disorder (MDD)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Oxidative stress

  Before intervention, at week 4 during the intervention, at week 8 of the intervention

• Brain derived neurotrophic factors, BDNF

  Before intervention, at week 4 during the intervention, at week 8 of the intervention

• Verbal learning and memory

  Before intervention, at week 4 during the intervention, at week 8 of the intervention

• Serum Interleukin-6

  Before intervention, at week 4 during the intervention, at week 8 of the intervention

Study Arms (2)

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

Dietary Supplement: stingless bee honey

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

Interventions

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

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults with ages 18 to 65
• with Major Depressive Disorder with scores of Beck Depression Inventory Malay version equal or more than 11

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universiti Sains Malaysia: lead

Study Sites (1)

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Sharifah Zubaidiah

  Universiti Sains Malaysia

  STUDY DIRECTOR

• Mohd Zulkifli Mustafa

  Universiti Sains Malaysia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Student of Master of science in medical physiology

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: December 15, 2024
• Primary Completion: August 10, 2025
• Study Completion: August 10, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

MY (1)