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Completed

NCT Number: NCT06723249

Stingless Bee Honey Augmentation in Major Depressive Disorders

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

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Key information

Conditions

Major Depressive Disorder (MDD) Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Depressive symptoms

    Time frame: 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 outcomes

  1. Oxidative stress

    Time frame: Before intervention, at week 4 during the intervention, at week 8 of the intervention

    Serum malondialdehyde concentrations in blood will be assessed

  2. Brain derived neurotrophic factors, BDNF

    Time frame: Before intervention, at week 4 during the intervention, at week 8 of the intervention

    Serum BDNF concentrations of blood will be assessed

  3. Verbal learning and memory

    Time frame: 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

  4. Serum Interleukin-6

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Hospital Universiti Sains Malaysia

Other

Registry information

Official study title

The Effect of Stingless Bee Honey on BDNF, Oxidative Stress, Depressive Symptoms and Verbal Learning and Memory in Major Depressive Disorders: A Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2024
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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