NCT07633080Recruiting
Magnesium Bisglycinate in Major Depressive Disorder
Efficacy and Safety of Add-on Magnesium Bisglycinate in Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 84 (estimated)
- First submitted
- 3 Jun 2026
- Start date
- 12 Jun 2026
- Primary completion date
- 12 May 2028
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Diseases
- Depression
- NCT number
- NCT07633080
What you commit to
- Study type: Interventional
- Planned participants: 84
- From 12 Jun 2026 to the primary completion date, 12 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of renal impairment (previous history of AKI, CKD, currently on dialysis).
- Electroconvulsive therapy (ECT) received within the past 3 months.
Other illness
- Diagnosis of bipolar affective disorder, schizoaffective disorder, schizophrenia, or any other psychotic disorder.
- Current substance use disorder (except nicotine, alcohol and caffeine), as per DSM-5 criteria.
- History of significant severe medical comorbidity, including uncontrolled hypothyroidism, Cushing's syndrome, active malignancy, myasthenia gravis, or severe hepatic impairment.
Lab values
- Known hypersensitivity or allergy to magnesium supplements or glycine.
- Concurrent use of magnesium-containing supplements, antacids, or laxatives.
- Use of medications with significant pharmacokinetic interactions with magnesium (e.g., tetracyclines, fluoroquinolones, bisphosphonates, diuretics) that cannot be temporally separated by ≥2 hours.
Other
- Active suicidal ideation with intent or a recent suicide attempt (within the past 6 months), as assessed by the treating psychiatrist.
- Pregnancy, lactation, or women of childbearing potential not using adequate contraception.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| All India Institute of Medical Sciences (AIIMS) Coordinator of this site? Confirm its status | Bhubaneswar | India | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.