Magnesium Supplementation With Fluoxetine for Cognitive Function in Depression

NCT07521358 | Completed

• 1 other identifier: 469/UN4.6.4.5.31/PP36/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Major Depressive Disorder (MDD)

Keywords

Magnesium Supplementation; Fluoxetine; Cognitive Function; Brain-Derived Neurotrophic Factor; Depression

Outcome Measures

Primary Outcomes (1)

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

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

  Baseline and 6 weeks

Secondary Outcomes (1)

• Change in Serum Brain-Derived Neurotrophic Factor (BDNF) Levels

  Baseline and 6 weeks

Study Arms (2)

Fluoxetine + Magnesium

EXPERIMENTAL

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

Drug: Fluoxetine (drug); Dietary Supplement: Magnesium

Fluoxetine Alone

ACTIVE COMPARATOR

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

Drug: Fluoxetine (drug)

Interventions

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.

Fluoxetine + Magnesium; Fluoxetine Alone

Magnesium DIETARY_SUPPLEMENT

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

Fluoxetine + Magnesium

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hasanuddin University: lead

Study Sites (1)

Dr. Wahidin Sudirohusodo Hospital

Makassar, South Sulawesi, 90245, Indonesia

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Fluoxetine; Pharmaceutical Preparations; Magnesium

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals, Light; Metals

Study Officials

• Nurdiana Julianti Noor, MD, M.Biomed

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is a single-blind study in which participants are unaware of their group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomly assigned to two parallel groups: one group receives fluoxetine with magnesium supplementation, and the other group receives fluoxetine alone. Outcomes are assessed at baseline and after 6 weeks.

Study Record Dates

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

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)