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Completed

NCT Number: NCT07521358

Magnesium Supplementation With Fluoxetine for Cognitive Function in Depression

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

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Key information

Conditions

Major Depressive Disorder (MDD) Behavior Behavioral Symptoms Depression Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dr. Wahidin Sudirohusodo Hospital

Makassar, South Sulawesi, 90245, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluoxetine (drug)

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.

magnesium

Dietary Supplement

Magnesium supplementation administered orally at a dose of 350 mg once daily as adjunct therapy to fluoxetine for 6 weeks.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Hasanuddin University

Other

Registry information

Official study title

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

Acronym: MAG-DEP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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