Effect of Zinc Supplementation on Depression in SSRI-treated Major Depressive Disorder Patients
Status:
Completed
Trial end date:
2020-08-20
Target enrollment:
Participant gender:
Summary
Title:
Effect of zinc supplementation on depression in SSRIs-treated MDD patients.
Purpose: Depression is the single largest contributor to global disability as has been ranked
by WHO (2015), in humans including both male and female.Studies have suggested that
conventional presently available anti-depressive medicines are effective for one third to
one-half (19-34%) of the patients suffering from depression, leaving the rest of patients to
suffer from recurrence or incomplete cure. Researchers throughout the world are involved to
obtain new pharmacotherapy for the treatment of MDD. Zinc is an important micronutrient of
the human body which is implicated as an essential component in various systemic wellbeing
including the central nervous system.
Methods: The study would be randomized, double-blind, placebo-controlled prospective
interventional trial and it would be conducted in the Department of Pharmacology and in
collaboration with the Department of Psychiatry, BSMMU, from date of approval by the IRB to
August 2020. A total of 100 patients suffering from mild to moderate major depression will be
selected following to inclusion and exclusion criteria and serum Zinc levels will be
assessed. The diagnosis of patients suffering from MDD and the selection of drugs and dosage
would be performed by a senior professor of the Psychiatry department. After completing the
necessary formalities including the informed consent of the patients, the patient would
undergo a selected questionnaire (DASS-21) to assess his/her degree of severity of the
disease. The patients would be randomly allocated into two groups: group A (control group)
and B (intervention group). Group A would consist of 50 patients who will receive a placebo
with SSRIs for 8 weeks. Group B would consist of 50 patients who will receive SSRIs plus Zinc
sulfate (30mg/day) orally for 8 weeks, after which at follow up, the severity of depression
will be assessed. The blood sample will be collected to measure serum zinc level at baseline
and again after 8 weeks of therapeutic intervention.
Ethical consideration
The study will follow the principles of the Declaration of Helsinki and of the World Medical
Assembly. Patients will be informed about the study in easy language and then informed
consent will be taken. The study has no potential risk to the patients. Confidentiality will
be strictly maintained.
Phase:
N/A
Details
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh