Magnesium Bisglycinate in Major Depressive Disorder (NCT07633080) | Clinical Trial Compass
RecruitingNot Applicable
Magnesium Bisglycinate in Major Depressive Disorder
India84 participantsStarted 2026-06-12
Plain-language summary
Depression is a common illness that can affect a person's mood, sleep, energy, ability to work, and overall quality of life. While medicines are available to treat depression, many people do not get complete relief from their symptoms. This study will evaluate whether adding a magnesium supplement in the form of magnesium bisglycinate to regular antidepressant treatment can help improve symptoms of depression. Adults with depression who are already receiving treatment will be randomly assigned to receive either magnesium bisglycinate or a placebo (an inactive substance) along with their usual medication. The study will compare the two groups to see whether the supplement leads to greater improvement in symptoms, sleep, and day-to-day functioning. Information on any side effects will also be collected. The findings may help determine whether magnesium bisglycinate can be used as a safe and affordable additional treatment for people with depression.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients with a diagnosis of Major Depressive Disorder (MDD) as per DSM-5 criteria.
. Patients of either sex within the age group of 18-65 years.
. Mild to severe depression, defined as a baseline MADRS score ≥7.
. Currently receiving a stable dose of antidepressant monotherapy (SSRI or SNRI) in equivalent doses.
. Willing and able to provide written informed consent.
Exclusion criteria
. Known hypersensitivity or allergy to magnesium supplements or glycine.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing magnesium bisglycinate as a treatment for major depressive disorder — how does that compare to the standard antidepressant medications you might already be recommending for me, and would trying a standard treatment first make more sense given where I am right now?
2The trial is listed as 'not yet recruiting,' which means it hasn't started enrolling patients — do you know when it might open, and is waiting for it a realistic option given how urgent my situation is?
3The phase is listed as 'NA,' which I understand might mean it's not a traditional drug trial — can you help me understand what that means for how much is already known about the safety and effectiveness of magnesium bisglycinate at the doses being studied?
4The trial is measuring changes in depression severity using a scale called the MADRS — can you explain what a meaningful improvement on that scale would actually look like in terms of how I'd feel day to day?
5Since this involves taking a supplement rather than a prescription drug, are there any interactions with medications I'm already taking or health conditions I have that would make this worth being cautious about, even in a research setting?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score
Timeframe: Baseline (week 0) and follow-up (week 8)
Trial details
NCT IDNCT07633080
SponsorAll India Institute of Medical Sciences, Bhubaneswar
. History of renal impairment (previous history of AKI, CKD, currently on dialysis).
. Diagnosis of bipolar affective disorder, schizoaffective disorder, schizophrenia, or any other psychotic disorder.
. Active suicidal ideation with intent or a recent suicide attempt (within the past 6 months), as assessed by the treating psychiatrist.
. Current substance use disorder (except nicotine, alcohol and caffeine), as per DSM-5 criteria.
. Pregnancy, lactation, or women of childbearing potential not using adequate contraception.
. Concurrent use of magnesium-containing supplements, antacids, or laxatives.
. History of significant severe medical comorbidity, including uncontrolled hypothyroidism, Cushing's syndrome, active malignancy, myasthenia gravis, or severe hepatic impairment.