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

NCT07458022 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: ERC No. 31/2024
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Role of Magnesium in Depressive Disorder

Conditions

Major Depressive Diorder

Keywords

Major Depressive; selective serotonin; magnesium; combination therapy symptoms

Outcome Measures

Primary Outcomes (1)

• Change in severity of depressive symptoms

  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

Study Arms (2)

Interventional Arm

EXPERIMENTAL

Patients in this group will be treated with SSRI and magnesium therapy for four weeks

Drug: Use of magnesium with SSRI

Placebo

PLACEBO COMPARATOR

Patients in this group will be treated with SSRI as a placebo in interventional treatment.

Drug: SSRI

Interventions

SSRI DRUG

Only SSRI will be given

Placebo

Use of magnesium with SSRI DRUG

Impact of combination of SSRI and Magnesium in Major Depressive Disorder

Interventional Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Child Health Sciences and Children's Hospital, Lahore: lead

Study Sites (1)

Combined Military Hospital (CMH)

Multan, Punjab Province, 60000, Pakistan

Location

Related Links

• Older adults with hypertension have an increased risk of depression compared to their younger counterparts
• Management of treatment-resistant depression: challenges and strategies. Neuropsychiatric disease and treatment.
• Dietary magnesium intake and risk of depression. Journal of affective disorders.
• Possible relation between consumption of different food groups and depression.
• The way to a human's brain goes through their stomach: dietary factors in major depressive disorder

MeSH Terms

Interventions

Selective Serotonin Reuptake Inhibitors

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

Study Officials

• Atif Najum, MBBS, FCPS

  CMH Multan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Ahmad Yar

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 9, 2026
• Study Start: December 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)