Major Depressive Disorder (MDD)NCT06723249
Stingless Bee Honey Augmentation in Major Depressive Disorders
A study testing stingless bee honey in people with Major Depressive Disorder (MDD), run by Hospital Universiti Sains Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- stingless bee honey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteMalaysia
- Study dates
- 15 Dec 2024to 10 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults with ages 18 to 65
- with Major Depressive Disorder with scores of Beck Depression Inventory Malay version equal or more than 11
Who cannot join
- 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,
Show all 14Show fewer
- bipolar disorder,
- substance-use disorder,
- suicidal ideation or attempt,
- dementia,
- Alzheimer disease,
- diabetic,
- hypertension,
- chronic kidney disease
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, 16150
About this study
Official 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
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:
- Is there any effect of SBH on depressive symptoms between intervention and control groups in MDD?
- Are there any effects of SBH on BDNF between intervention and control groups in MDD?
- Are there any effects of SBH on oxidative stress between intervention and control groups in MDD?
- Are there any effects of SBH on verbal learning and memory between intervention and control groups in MDD?
Read more
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
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- stingless bee honey
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stingless bee honeyDietary 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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Before intervention, at week 4 during the intervention, at week 8 of the intervention
Secondary outcomes (4)
Oxidative stress
Serum malondialdehyde concentrations in blood will be assessed
Measured: Before intervention, at week 4 during the intervention, at week 8 of the intervention
Brain derived neurotrophic factors, BDNF
Serum BDNF concentrations of blood will be assessed
Measured: 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
Measured: 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
Measured: Before intervention, at week 4 during the intervention, at week 8 of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start15 Dec 2024
- Primary completion10 Aug 2025
- Study completion10 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ong Wailoon, Hospital Universiti Sains Malaysia
- Investigators
- Sharifah Zubaidiah, Study director, Universiti Sains MalaysiaMohd Zulkifli Mustafa, Study director, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06723249
- Sponsor's protocol ID
- USM/JEPeM/KK/24020180
- Other IDs
- TCTR20240621001
- Status last verified
- May 2025
- First submitted
- 4 Dec 2024
- Last updated
- 23 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06723249
- Acronym / sponsor ID
- USM/JEPeM/KK/24020180
- Conditions
- Major Depressive Disorder (MDD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hospital Universiti Sains MalaysiaUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 10 Aug 2025 (actual)
- Study completion
- 10 Aug 2025 (actual)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is there any effect of SBH on depressive symptoms between intervention and control groups in MDD?
- Are there any effects of SBH on BDNF between intervention and control groups in MDD?
- Are there any effects of SBH on oxidative stress between intervention and control groups in MDD?
- 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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Dietary Supplement: stingless bee honeyThe 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 |
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults with ages 18 to 65
- with Major Depressive Disorder with scores of Beck Depression Inventory Malay version equal or more than 11
Key exclusion criteria (14 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stingless bee honeyParticipants 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 | Dietary supplement | Intervention group |
Primary outcome
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).
4 secondary outcomes
Oxidative stress
Time frame: Before intervention, at week 4 during the intervention, at week 8 of the intervention
Brain derived neurotrophic factors, BDNF
Time frame: Before intervention, at week 4 during the intervention, at week 8 of the intervention
Verbal learning and memory
Time frame: Before intervention, at week 4 during the intervention, at week 8 of the intervention
Serum Interleukin-6
Time frame: Before intervention, at week 4 during the intervention, at week 8 of the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharifah Zubaidiah study director
Universiti Sains Malaysia
Mohd Zulkifli Mustafa study director
Universiti Sains Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stingless bee honey in people with Major Depressive Disorder (MDD), run by Hospital Universiti Sains Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: Before intervention, at week 4 during the intervention, at week 8 of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2025.