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

NCT04482296 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-01-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

SSRI with Zinc Sulfate

Zinc sulfate (30 mg) once daily for 8 weeks SSRI

Sponsors & Collaborators

  • Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

    lead OTHER

Principal Investigators

  • Satabdi Ghosh, MBBS · BSMMU(Recruiting), Dhaka, Bangladesh, 1000

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-15
Primary Completion
2020-07-15
Completion
2020-08-20

Countries

  • Bangladesh

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04482296 on ClinicalTrials.gov