Magnesium Supplementation With Fluoxetine for Cognitive Function in Depression (MAG-DEP)

April 3, 2026 updated by: Nurdiana Julianti Noor, Hasanuddin University

Effects of Magnesium Supplementation on Serum Brain-Derived Neurotrophic Factor Levels and Cognitive Function in Patients With Depression Receiving Fluoxetine Therapy

The goal of this clinical trial is to evaluate whether magnesium supplementation can improve cognitive function in patients with depression receiving fluoxetine therapy. It also aims to assess its effect on serum brain-derived neurotrophic factor (BDNF) levels in adult patients with depression.

The main questions it aims to answer are:

  • Does magnesium supplementation improve cognitive function in patients with depression receiving fluoxetine?
  • Does magnesium supplementation increase serum BDNF levels in these patients? Researchers will compare patients receiving fluoxetine with magnesium supplementation to those receiving fluoxetine alone to determine whether magnesium provides additional benefits.

Participants will:

  • Receive fluoxetine therapy with or without magnesium supplementation for 6 weeks
  • Undergo cognitive assessment using the Montreal Cognitive Assessment (MoCA) at baseline and after treatment
  • Provide blood samples for measurement of serum BDNF levels at baseline and after 6 weeks

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Depression is associated with persistent cognitive impairment, including deficits in attention, memory, and executive function, which may not fully improve with standard antidepressant treatment. These cognitive deficits contribute to functional disability and reduced quality of life. Fluoxetine, a selective serotonin reuptake inhibitor, is widely used as first-line therapy for depression. However, its effects on cognitive function are inconsistent, and additional strategies are needed to enhance cognitive recovery.

Magnesium plays an important role in neurobiological processes, including modulation of NMDA receptors and synaptic plasticity, and has been proposed as an adjunctive treatment in depression. It may influence neuroplasticity-related pathways, including brain-derived neurotrophic factor (BDNF).

This study is a randomized, single-blind, controlled clinical trial with a pretest-posttest design conducted in adult patients with depression receiving fluoxetine therapy. Participants are allocated into two parallel groups: an intervention group receiving oral magnesium supplementation (350 mg/day) in addition to fluoxetine, and a control group receiving fluoxetine alone.

Cognitive function is evaluated using a standardized cognitive assessment tool, and serum BDNF levels are measured using laboratory-based assays at baseline and after a 6-week intervention period.

This study aims to explore the potential role of magnesium as an adjunctive therapy to enhance neurocognitive outcomes and to provide insight into the relationship between neuroplasticity biomarkers and cognitive improvement in patients with depression.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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

  • Indonesia
    • South Sulawesi
      • Makassar, South Sulawesi, Indonesia, 90245
        • Dr. Wahidin Sudirohusodo Hospital

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients aged 18-60 years
  • Diagnosed with major depressive disorder based on clinical assessment
  • Receiving fluoxetine therapy
  • Able to understand and provide informed consent

Exclusion Criteria:

  • History of other major psychiatric disorders (e.g., schizophrenia, bipolar disorder)
  • Severe medical or neurological illness
  • Use of other psychotropic medications that may affect cognitive function
  • Known hypersensitivity to magnesium
  • Pregnancy or breastfeeding
  • Inability to complete cognitive assessment

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fluoxetine + Magnesium
Participants receive fluoxetine therapy combined with oral magnesium supplementation (350 mg/day) for 6 weeks.
Drug: Fluoxetine (drug)
Fluoxetine is administered as standard antidepressant therapy according to clinical indication. Fluoxetine administered orally at a dose of 20 mg once daily for 6 weeks.
Dietary supplement: Magnesium
Magnesium supplementation administered orally at a dose of 350 mg once daily as adjunct therapy to fluoxetine for 6 weeks.
Active Comparator: Fluoxetine Alone
Participants receive fluoxetine therapy alone for 6 weeks without additional supplementation.
Drug: Fluoxetine (drug)
Fluoxetine is administered as standard antidepressant therapy according to clinical indication. Fluoxetine administered orally at a dose of 20 mg once daily for 6 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cognitive Function Assessed by Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline and 6 weeks
Change in cognitive function measured by Montreal Cognitive Assessment (MoCA) score from baseline to 6 weeks after intervention.
Baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Serum Brain-Derived Neurotrophic Factor (BDNF) Levels
Time Frame: Baseline and 6 weeks
Change in serum BDNF levels measured from baseline to 6 weeks after intervention.
Baseline and 6 weeks

Collaborators and Investigators

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

Sponsor

Hasanuddin University

Investigators

  • Principal Investigator: Nurdiana Julianti Noor, MD, M.Biomed, Hasanuddin University

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)

July 1, 2025

Primary Completion (Actual)

August 1, 2025

Study Completion (Actual)

August 1, 2025

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

April 3, 2026

First Posted (Actual)

April 9, 2026

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 3, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 469/UN4.6.4.5.31/PP36/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because there is no plan for public data sharing for this study.

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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