NCT07633080

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable major-depressive-disorder

Timeline
22mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Jun 2026Jun 2028

First Submitted

Initial submission to the registry

June 3, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

June 12, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2028

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2028

Last Updated

June 15, 2026

Status Verified

June 1, 2026

Enrollment Period

1.9 years

First QC Date

June 3, 2026

Last Update Submit

June 12, 2026

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (1)

  • Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score

    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).

    Baseline (week 0) and follow-up (week 8)

Secondary Outcomes (9)

  • Change in Hamilton Anxiety Rating Scale (HAM-A) score

    Baseline (week 0) and follow-up (week 8)

  • Change in Pittsburgh Sleep Quality Index (PSQI) score

    Baseline (week 0) and follow-up (week 8)

  • Change in Epworth Sleepiness Scale (ESS) score

    Baseline (week 0) and follow-up (week 8)

  • Change in Clinical Global Impression Severity (CGI-S) score

    Baseline (week 0) and follow-up (week 8)

  • Clinical Global Impression Improvement (CGI-I)

    Week 8

  • +4 more secondary outcomes

Study Arms (2)

Control arm

PLACEBO COMPARATOR

The control arm will receive an add-on placebo (microcrystalline cellulose capsules) once daily along with Standard of care (SSRI/SNRI) for 8 weeks.

Other: Microcrystalline cellulose

Test arm

EXPERIMENTAL

The test arm will receive add-on Magnesium bisglycinate (220 mg elemental magnesium per day) once daily along with Standard of care (SSRI/SNRI) for 8 weeks.

Dietary Supplement: Magnesium Bisglycinate

Interventions

Magnesium BisglycinateDIETARY_SUPPLEMENT

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

Test arm
Microcrystalline celluloseOTHER

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.

Control arm

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Known hypersensitivity or allergy to magnesium supplements or glycine.
  • 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.
  • Use of medications with significant pharmacokinetic interactions with magnesium (e.g., tetracyclines, fluoroquinolones, bisphosphonates, diuretics) that cannot be temporally separated by ≥2 hours.
  • Electroconvulsive therapy (ECT) received within the past 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

All India Institute of Medical Sciences (AIIMS)

Bhubaneswar, Odisha, 751019, India

RECRUITING

Related Publications (10)

  • Riemann D, Krone LB, Wulff K, Nissen C. Sleep, insomnia, and depression. Neuropsychopharmacology. 2020 Jan;45(1):74-89. doi: 10.1038/s41386-019-0411-y. Epub 2019 May 9.

    PMID: 31071719RESULT

  • Tripathi A, Shukla R, Kar SK, Gupta S, Saran P, Pattojoshi A, Rao T. Clinical practice guideline for assessment and management of depression in India. Indian J Psychiatry. 2026 Jan;68(1):68-93. doi: 10.4103/indianjpsychiatry_1321_25. Epub 2026 Jan 27.

    PMID: 41694045RESULT

  • Wichniak A, Wierzbicka A, Walecka M, Jernajczyk W. Effects of Antidepressants on Sleep. Curr Psychiatry Rep. 2017 Aug 9;19(9):63. doi: 10.1007/s11920-017-0816-4.

    PMID: 28791566RESULT

  • Meng Y, Liu S, Yu M, Liang H, Tong Y, Song J, Shi J, Cai W, Wu Q, Wen Z, Wang J, Guo F. The Changes of Blood and CSF Ion Levels in Depressed Patients: a Systematic Review and Meta-analysis. Mol Neurobiol. 2024 Aug;61(8):5369-5403. doi: 10.1007/s12035-023-03891-x. Epub 2024 Jan 8.

    PMID: 38191692RESULT

  • Pochwat B, Szewczyk B, Sowa-Kucma M, Siwek A, Doboszewska U, Piekoszewski W, Gruca P, Papp M, Nowak G. Antidepressant-like activity of magnesium in the chronic mild stress model in rats: alterations in the NMDA receptor subunits. Int J Neuropsychopharmacol. 2014 Mar;17(3):393-405. doi: 10.1017/S1461145713001089. Epub 2013 Sep 26.

    PMID: 24067405RESULT

  • Pochwat B, Sowa-Kucma M, Kotarska K, Misztak P, Nowak G, Szewczyk B. Antidepressant-like activity of magnesium in the olfactory bulbectomy model is associated with the AMPA/BDNF pathway. Psychopharmacology (Berl). 2015 Jan;232(2):355-67. doi: 10.1007/s00213-014-3671-6. Epub 2014 Jul 16.

    PMID: 25027582RESULT

  • Moabedi M, Aliakbari M, Erfanian S, Milajerdi A. Magnesium supplementation beneficially affects depression in adults with depressive disorder: a systematic review and meta-analysis of randomized clinical trials. Front Psychiatry. 2023 Dec 22;14:1333261. doi: 10.3389/fpsyt.2023.1333261. eCollection 2023.

    PMID: 38213402RESULT

  • Kawai N, Sakai N, Okuro M, Karakawa S, Tsuneyoshi Y, Kawasaki N, Takeda T, Bannai M, Nishino S. The sleep-promoting and hypothermic effects of glycine are mediated by NMDA receptors in the suprachiasmatic nucleus. Neuropsychopharmacology. 2015 May;40(6):1405-16. doi: 10.1038/npp.2014.326. Epub 2014 Dec 23.

    PMID: 25533534RESULT

  • Pardo MR, Garicano Vilar E, San Mauro Martin I, Camina Martin MA. Bioavailability of magnesium food supplements: A systematic review. Nutrition. 2021 Sep;89:111294. doi: 10.1016/j.nut.2021.111294. Epub 2021 Apr 28.

    PMID: 34111673RESULT

  • Schuster J, Cycelskij I, Lopresti A, Hahn A. Magnesium Bisglycinate Supplementation in Healthy Adults Reporting Poor Sleep: A Randomized, Placebo-Controlled Trial. Nat Sci Sleep. 2025 Aug 30;17:2027-2040. doi: 10.2147/NSS.S524348. eCollection 2025.

    PMID: 40918053RESULT

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

microcrystalline cellulose

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Study Officials

  • Debasish Hota, D.M.

    AIIMS, Bhubaneswar

    STUDY CHAIR

Central Study Contacts

Rituparna Maiti, M.D.

CONTACT

9438884191pharm_rituparna@aiimsbhubaneswar.edu.in

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 3, 2026

First Posted

June 8, 2026

Study Start

June 12, 2026

Primary Completion (Estimated)

May 12, 2028

Study Completion (Estimated)

June 12, 2028

Last Updated

June 15, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data (IPD) available to other researchers outside the study team. Data will be used solely for the purposes of the present research and reported in aggregate form in study publications and presentations.

Locations

IN(1)