Magnesium Bisglycinate in Major Depressive Disorder

NCT07633080 · tracked via the Priya Life Science India tracker

Sponsor

All India Institute of Medical Sciences, Bhubaneswar

Phase

Not applicable

Started

2026-06-12

Last updated

2026-06-15

Condition(s) studied

Major Depressive Disorder

Investigational drug(s) / intervention(s)

Magnesium BisglycinateMicrocrystalline cellulose

Magnesium Bisglycinate: Magnesium Bisglycinate (220 mg elemental mangnesium and 1350 mg glycine) per day for 8 weeks

Microcrystalline cellulose: The placebo capsules will contain Microcrystalline cellulose (inactive excipient) and will be of similar colour, shape and size as of magnesium bisglycinate capsules and will be given once daily for 8 weeks.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

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.

Primary outcome measure(s)

Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score — Baseline (week 0) and follow-up (week 8)
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a clinician-administered instrument used to assess the severity of depressive symptoms. It consists of 10 items, each scored from 0 to 6, yielding a total score ranging from 0 to 60, where higher scores indicate greater severity of depression. MADRS scores are commonly interpreted as 0-6 (normal or symptom absent), 7-19 (mild depression), 20-34 (moderate depression), and ≥35 (severe depression).

Trial sites (1)

Facility	City	Region	Status
All India Institute of Medical Sciences (AIIMS)	Bhubaneswar	Odisha	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07633080 on ClinicalTrials.gov ↗ ← All trials in India