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

NCT04482296 | Completed

• 1 other identifier: BSMMU/2019/8875
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

MDD

Keywords

Zinc; SSRI; MDD

Outcome Measures

Primary Outcomes (1)

• To measure the serum zinc level in SSRI-treated MDD patients pre and post supplementation of zinc.

  8 weeks

Study Arms (2)

SSRI with placebo

NO INTERVENTION

50 patients who will receive placebo with SSRIs for 8 weeks

SSRI with zinc sulfate

ACTIVE COMPARATOR

50 patients who will receive SSRIs with zinc sulfate for 8 weeks

Drug: SSRI with Zinc Sulfate

Interventions

SSRI with Zinc Sulfate DRUG

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

SSRI with zinc sulfate

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

BSMMU

Dhaka, Bangladesh

Location

MeSH Terms

Interventions

Selective Serotonin Reuptake Inhibitors; Zinc Sulfate

Intervention Hierarchy (Ancestors)

Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds

Study Officials

• Satabdi Ghosh, MBBS

  BSMMU(Recruiting), Dhaka, Bangladesh, 1000

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 22, 2020
• Study Start: September 15, 2019
• Primary Completion: July 15, 2020
• Study Completion: August 20, 2020
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)