Major Depressive DiorderPhase 2NCT07458022
MAGNESIUM & SSRI VS SSRI ALONE AMONG PATIENTS OF MAJOR DEPRESSIVE DISORDER
A Phase 2 study testing Use of magnesium with SSRI and SSRI in people with Major Depressive Diorder, run by University of Child Health Sciences and Children's Hospital, Lahore at 1 site in Pakistan.
Trial summary
Role of Magnesium in Depressive Disorder Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Diorder
- What is being tested?
- Use of magnesium with SSRI and SSRI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Dec 2025to Apr 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients of above 18 years diagnosed with DSM who had MDD and receiving SSRI alone and SSRI plus magnesium.
Who cannot join
- Individuals who recently underwent treatment with electroconvulsive therapy, have a history of epilepsy or other severe neurological problems, have experienced a head injury, are cognitively impaired, and have comorbid conditions such as liver, renal, cardiovascular, neurological, or endocrine, or respiratory problems, or are pregnant or nursing mothers
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Combined Military Hospital (CMH)
Multan, Punjab Province, 60000
About this study
Role of Magnesium in Depressive Disorder
Read the detailed description
Because of the significant role that magnesium serves in mood regulation, the goal of this study is to evaluate the impact of starting the therapy of major depressive disorder with a combination of SSRI and Mg, as well as SSRI alone.
- Conditions
- Major Depressive Diorder
- Being tested
- Use of magnesium with SSRI, SSRI
- Keywords
- Major Depressive, selective serotonin, magnesium, combination therapy symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of magnesium with SSRIDrug
Impact of combination of SSRI and Magnesium in Major Depressive Disorder
SSRIDrug
Only SSRI will be given
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm | Experimental | Patients in this group will be treated with SSRI and magnesium therapy for four weeks Receives: Drug: Use of magnesium with SSRI |
| Placebo | Placebo comparator | Patients in this group will be treated with SSRI as a placebo in interventional treatment. Receives: Drug: SSRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in severity of depressive symptoms
Change in severity of depressive symptoms, measured by the difference in mean scores on the Beck Depression Inventory-II (BDI-II) from baseline to 4 weeks post-intervention
Measured: Four Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 Dec 2025
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DiorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Child Health Sciences and Children's Hospital, Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Yar, University of Child Health Sciences and Children's Hospital, Lahore
- Investigators
- Atif Najum, MBBS, FCPS, Study chair, CMH Multan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458022
- Sponsor's protocol ID
- ERC No. 31/2024
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient Confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MAGNESIUM & SSRI VS SSRI ALONE AMONG PATIENTS OF MAJOR DEPRESSIVE DISORDER
- ClinicalTrials.gov ID
- NCT07458022
- Acronym / sponsor ID
- ERC No. 31/2024
- Conditions
- Major Depressive Diorder
- Keywords
- Major Depressive, selective serotonin, magnesium, combination therapy symptoms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of Child Health Sciences and Children's Hospital, LahoreUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 9 Mar 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.
Role of Magnesium in Depressive Disorder
Detailed description
Because of the significant role that magnesium serves in mood regulation, the goal of this study is to evaluate the impact of starting the therapy of major depressive disorder with a combination of SSRI and Mg, as well as SSRI alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Drug: Use of magnesium with SSRIPatients in this group will be treated with SSRI and magnesium therapy for four weeks |
| Placebo | Placebo comparator | Drug: SSRIPatients in this group will be treated with SSRI as a placebo in interventional treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients of above 18 years diagnosed with DSM who had MDD and receiving SSRI alone and SSRI plus magnesium.
Key exclusion criteria (1 listed)
- Individuals who recently underwent treatment with electroconvulsive therapy, have a history of epilepsy or other severe neurological problems, have experienced a head injury, are cognitively impaired, and have comorbid conditions such as liver, renal, cardiovascular, neurological, or endocrine, or respiratory problems, or are pregnant or nursing mothers
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 |
|---|---|---|
| Use of magnesium with SSRIImpact of combination of SSRI and Magnesium in Major Depressive Disorder | Drug | Interventional Arm |
| SSRIOnly SSRI will be given | Drug | Placebo |
Primary outcome
Change in severity of depressive symptoms
Time frame: Four Weeks
Change in severity of depressive symptoms, measured by the difference in mean scores on the Beck Depression Inventory-II (BDI-II) from baseline to 4 weeks post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Older adults with hypertension have an increased risk of depression compared to their younger counterpartsLink provided by the sponsor.
- Management of treatment-resistant depression: challenges and strategies. Neuropsychiatric disease and treatment.Link provided by the sponsor.
- Dietary magnesium intake and risk of depression. Journal of affective disorders.Link provided by the sponsor.
- Possible relation between consumption of different food groups and depression.Link provided by the sponsor.
- The way to a human's brain goes through their stomach: dietary factors in major depressive disorderLink provided by the sponsor.
- Individual participant dataSharing planned: No. Patient Confidentiality
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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.
Atif Najum, MBBS, FCPS study chair
CMH Multan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Use of magnesium with SSRI and SSRI in people with Major Depressive Diorder, run by University of Child Health Sciences and Children's Hospital, Lahore at 1 site in Pakistan.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 9 Mar 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 Pakistan. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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 severity of depressive symptoms (time frame: Four 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 Mar 2026.