Clinical trial NCT06723249: Stingless Bee Honey Augmentation in Major Depressive Disorders: A Randomized Clinical Trial
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Major Depressive Disorder (MDD)
Lead sponsor: Hospital Universiti Sains Malaysia
Sponsor class: OTHER
Collaborators: name: Government of Malaysia
First posted: 2024-12-09
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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

Primary outcomes:
measure: Depressive symptoms
timeFrame: Before intervention, at week 4 during the intervention, at week 8 of the intervention
Secondary outcomes:
measure: Oxidative stress
timeFrame: Before intervention, at week 4 during the intervention, at week 8 of the intervention
measure: Brain derived neurotrophic factors, BDNF
timeFrame: Before intervention, at week 4 during the intervention, at week 8 of the intervention
measure: Verbal learning and memory
timeFrame: Before intervention, at week 4 during the intervention, at week 8 of the intervention
Other outcomes:
Locations:
Study officials:
affiliation: Universiti Sains Malaysia
name: Sharifah Zubaidiah
role: STUDY_DIRECTOR
affiliation: Universiti Sains Malaysia
name: Mohd Zulkifli Mustafa
role: STUDY_DIRECTOR
References: