Magnesium Bisglycinate Added to Your Depression Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, randomized, double-blind, placebo-controlled trial that compares magnesium bisglycinate added to standard antidepressant therapy versus placebo. Adults aged 18-65 with a DSM-5 diagnosis of major depressive disorder and a MADRS score of 7 or higher will be enrolled while on stable SSRI or SNRI treatment. Participants will be randomized in a 2:1 ratio to receive either magnesium bisglycinate or placebo for a defined period, with allocation concealed and blinding maintained for participants, clinicians, and outcome assessors. The primary aim is to determine if adjunctive magnesium improves depressive symptoms; secondary aims include effects on sleep and daily functioning and monitoring safety and tolerability. The study will collect data on adverse events and other clinical parameters to evaluate safety and potential benefits of this adjunctive approach.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with a diagnosis of Major Depressive Disorder (MDD) as per DSM-5 criteria.
2. Patients of either sex within the age group of 18-65 years.
3. Mild to severe depression, defined as a baseline MADRS score ≥7.
4. Currently receiving a stable dose of antidepressant monotherapy (SSRI or SNRI) in equivalent doses.
5. Willing and able to provide written informed consent.

Exclusion Criteria:

1. Known hypersensitivity or allergy to magnesium supplements or glycine.
2. History of renal impairment (previous history of AKI, CKD, currently on dialysis).
3. Diagnosis of bipolar affective disorder, schizoaffective disorder, schizophrenia, or any other psychotic disorder.
4. Active suicidal ideation with intent or a recent suicide attempt (within the past 6 months), as assessed by the treating psychiatrist.
5. Current substance use disorder (except nicotine, alcohol and caffeine), as per DSM-5 criteria.
6. Pregnancy, lactation, or women of childbearing potential not using adequate contraception.
7. Concurrent use of magnesium-containing supplements, antacids, or laxatives.
8. History of significant severe medical comorbidity, including uncontrolled hypothyroidism, Cushing's syndrome, active malignancy, myasthenia gravis, or severe hepatic impairment.
9. Use of medications with significant pharmacokinetic interactions with magnesium (e.g., tetracyclines, fluoroquinolones, bisphosphonates, diuretics) that cannot be temporally separated by ≥2 hours.
10. Electroconvulsive therapy (ECT) received within the past 3 months.

Where it's running

• All India Institute of Medical Sciences (AIIMS)
  Bhubaneswar, Odisha, India Recruiting

Study contacts

• Study coordinator: Rituparna Maiti, M.D.
• Email: pharm_rituparna@aiimsbhubaneswar.edu.in
• Phone: 9438884191

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.