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临床试验/NCT07521358
NCT07521358已完成不适用

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

Hasanuddin University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Change in Cognitive Function Assessed by Montreal Cognitive Assessment (MoCA)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

This is a single-blind study in which participants are unaware of their group allocation.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Fluoxetine + Magnesium

Experimental

Participants receive fluoxetine therapy combined with oral magnesium supplementation (350 mg/day) for 6 weeks.

干预措施: Fluoxetine (drug) (Drug)

Fluoxetine + Magnesium

Experimental

Participants receive fluoxetine therapy combined with oral magnesium supplementation (350 mg/day) for 6 weeks.

干预措施: Magnesium (Dietary Supplement)

Fluoxetine Alone

Active Comparator

Participants receive fluoxetine therapy alone for 6 weeks without additional supplementation.

干预措施: Fluoxetine (drug) (Drug)

结局指标

主要结局

Change in Cognitive Function Assessed by Montreal Cognitive Assessment (MoCA)

时间窗: Baseline and 6 weeks

Change in cognitive function measured by Montreal Cognitive Assessment (MoCA) score from baseline to 6 weeks after intervention.

次要结局

  • Change in Serum Brain-Derived Neurotrophic Factor (BDNF) Levels(Baseline and 6 weeks)

研究者

发起方
Hasanuddin University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nurdiana Julianti Noor

Principal Investigator

Hasanuddin University

研究点 (1)

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