Stingless Bee Honey Augmentation in Major Depressive Disorders

Hospital Universiti Sains Malaysia

Status: Completed

Conditions: Major Depressive Disorder (MDD)

Treatments: Dietary Supplement: stingless bee honey

Study type: Interventional

Funder types: Other

Identifiers

NCT06723249

TCTR20240621001 (Registry Identifier)

USM/JEPeM/KK/24020180

Details and patient eligibility

About

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

Enrollment: 45 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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45 participants in 2 patient groups

Intervention group

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: stingless bee honey

Control group

No Intervention group

Description:

The participants in the control group will not receive stingless bee honey. They will continue treatment as usual, their pharmacological like antidepressants or psychotherapy