MAGNESIUM & SSRI VS SSRI ALONE AMONG PATIENTS OF MAJOR DEPRESSIVE DISORDER

Role of Magnesium in Depressive Disorder

Study Overview

Status

Active, not recruiting

Detailed Description

Because of the significant role that magnesium serves in mood regulation, the goal of this study is to evaluate the impact of starting the therapy of major depressive disorder with a combination of SSRI and Mg, as well as SSRI alone.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Punjab Province
      • Multan, Punjab Province, Pakistan, 60000
        • Combined Military Hospital (CMH)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

All patients of above 18 years diagnosed with DSM who had MDD and receiving SSRI alone and SSRI plus magnesium.

Exclusion Criteria:

Individuals who recently underwent treatment with electroconvulsive therapy, have a history of epilepsy or other severe neurological problems, have experienced a head injury, are cognitively impaired, and have comorbid conditions such as liver, renal, cardiovascular, neurological, or endocrine, or respiratory problems, or are pregnant or nursing mothers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interventional Arm
Patients in this group will be treated with SSRI and magnesium therapy for four weeks
Impact of combination of SSRI and Magnesium in Major Depressive Disorder
Placebo Comparator: Placebo
Patients in this group will be treated with SSRI as a placebo in interventional treatment.
Only SSRI will be given

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in severity of depressive symptoms
Time Frame: Four Weeks
Change in severity of depressive symptoms, measured by the difference in mean scores on the Beck Depression Inventory-II (BDI-II) from baseline to 4 weeks post-intervention
Four Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Atif Najum, MBBS, FCPS, CMH Multan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

March 3, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient Confidentiality

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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