Major Depressive Disorder (MDD)MAG-DEPNCT07521358
Magnesium Supplementation With Fluoxetine for Cognitive Function in Depression
A study testing Fluoxetine (drug) and Magnesium in people with Major Depressive Disorder (MDD), run by Hasanuddin University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- Fluoxetine (drug) and Magnesium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2025to 1 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Wahidin Sudirohusodo Hospital
Makassar, South Sulawesi, 90245
About this study
Official title: 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:
Read more
- 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
Read the 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)
- Being tested
- Fluoxetine (drug), Magnesium
- Keywords
- Magnesium Supplementation, Fluoxetine, Cognitive Function, Brain-Derived Neurotrophic Factor, Depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
MagnesiumDietary supplement
Magnesium supplementation administered orally at a dose of 350 mg once daily as adjunct therapy to fluoxetine for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Fluoxetine + Magnesium | Experimental | Participants receive fluoxetine therapy combined with oral magnesium supplementation (350 mg/day) for 6 weeks. Receives: Drug: Fluoxetine (drug); Dietary Supplement: Magnesium |
| Fluoxetine Alone | Active comparator | Participants receive fluoxetine therapy alone for 6 weeks without additional supplementation. Receives: Drug: Fluoxetine (drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 6 weeks
Secondary outcomes (1)
Change in Serum Brain-Derived Neurotrophic Factor (BDNF) Levels
Change in serum BDNF levels measured from baseline to 6 weeks after intervention.
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start1 Jul 2025
- Primary completion1 Aug 2025
- Study completion1 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder (MDD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasanuddin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurdiana Julianti Noor, Hasanuddin University
- Investigators
- Nurdiana Julianti Noor, MD, M.Biomed, Principal investigator, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521358
- Sponsor's protocol ID
- 469/UN4.6.4.5.31/PP36/2025
- Acronym
- MAG-DEP
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because there is no plan for public data sharing for this study.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Magnesium Supplementation on Serum Brain-Derived Neurotrophic Factor Levels and Cognitive Function in Patients With Depression Receiving Fluoxetine Therapy
- ClinicalTrials.gov ID
- NCT07521358
- Acronym / sponsor ID
- MAG-DEP / 469/UN4.6.4.5.31/PP36/2025
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Magnesium Supplementation, Fluoxetine, Cognitive Function, Brain-Derived Neurotrophic Factor, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hasanuddin UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Aug 2025 (actual)
- Study completion
- 1 Aug 2025 (actual)
- First posted
- 9 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Fluoxetine + Magnesium | Experimental | Drug: Fluoxetine (drug), Dietary Supplement: MagnesiumParticipants receive fluoxetine therapy combined with oral magnesium supplementation (350 mg/day) for 6 weeks. |
| Fluoxetine Alone | Active comparator | Drug: Fluoxetine (drug)Participants receive fluoxetine therapy alone for 6 weeks without additional supplementation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Fluoxetine + Magnesium, Fluoxetine Alone |
| MagnesiumMagnesium supplementation administered orally at a dose of 350 mg once daily as adjunct therapy to fluoxetine for 6 weeks. | Dietary supplement | Fluoxetine + Magnesium |
Primary outcome
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.
1 secondary outcome
Change in Serum Brain-Derived Neurotrophic Factor (BDNF) Levels
Time frame: Baseline and 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because there is no plan for public data sharing for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nurdiana Julianti Noor, MD, M.Biomed principal investigator
Hasanuddin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoxetine (drug) and Magnesium in people with Major Depressive Disorder (MDD), run by Hasanuddin University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cognitive Function Assessed by Montreal Cognitive Assessment (MoCA) (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026; AzTrials last refreshed its copy on 31 Oct 2026.