NCT07521358

Magnesium Supplementation With Fluoxetine for Cognitive Function in Depression

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Hasanuddin University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Major Depressive Disorder (MDD)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

1 site across 1 country: Indonesia