Effect of Zinc Supplementation on Depression in SSRI-treated Major Depressive Disorder Patients

• Status: Completed
• Trial end date: 2020-08-20
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Treatments: Zinc Sulfate

Criteria

Inclusion Criteria:

• Newly diagnosed patients with major depressive disorder diagnosed from the Psychiatry department of BSMMU according to the diagnostic protocol which fulfills DSM-4 criteria and SCID 1 Bangla version.

• Patients treated with only SSRIs.

• Mild to moderate MDD patients.

• Age: 18-55 years.

• Sex: Both male and female.

Exclusion criteria:

• Age < 18 years and > 55 years.

• Patients receiving other antidepressants and dietary supplements in the last two months.

• Patients with other psychiatric disorders (such as anxiety disorder, schizophrenia, bipolar disorder, alcoholism).