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Major Depressive DisorderDReAM-BiGNCT07633080

Magnesium Bisglycinate in Major Depressive Disorder

A study testing Magnesium Bisglycinate and Microcrystalline cellulose in people with Major Depressive Disorder, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Major Depressive Disorder
What is being tested?
Magnesium Bisglycinate and Microcrystalline cellulose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
84 participants
Where
1 siteIndia
Study dates
12 Jun 2026to 12 Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rituparna Maiti, M.D. contact

9438884191

pharm_rituparna@aiimsbhubaneswar.edu.in

India1 site, 1 recruiting

  • All India Institute of Medical Sciences (AIIMS)

    Bhubaneswar, Odisha, 751019

    RITUPARNA MAITI, MD, 9438884191, rituparnamaiti@gmail.com

    BISWA R MISHRA, MD, brm1678@gmail.com

    Recruiting

Other trials in India

About this study

Official title: Efficacy and Safety of Add-on Magnesium Bisglycinate in Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial

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.

Read the detailed description

The DREAM-BiG (Depression REsponse to Adjunctive Magnesium-BisGlycinate) study is a single-centre, randomized, double-blind, placebo-controlled, parallel-arm academic clinical trial designed to evaluate the efficacy and safety of adjunctive magnesium bisglycinate in adults with Major Depressive Disorder (MDD) receiving stable standard-of-care antidepressant therapy. The study will be conducted in the Departments of Pharmacology and Psychiatry at AIIMS Bhubaneswar. Eligible participants will be men and women aged 18-65 years with a DSM-5 diagnosis of MDD and mild-to-severe depressive symptoms, defined by a baseline Montgomery-Åsberg Depression Rating Scale (MADRS) score of ≥7, who are receiving a stable dose of a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI). Following written informed consent, participants will undergo detailed clinical evaluation, anthropometric assessment, and baseline measurement of clinical and biochemical parameters. A total of 84 participants will be randomization using computer-generated block randomization with a block size of six and a 2:1 allocation ratio favoring the intervention arm. Allocation concealment will be ensured through sequentially numbered, identical-appearing capsule containers, and participants, treating psychiatrists, outcome assessors, and investigators will remain blinded to treatment allocation throughout the study. Participants in the intervention group will receive magnesium bisglycinate capsules providing 220 mg elemental magnesium daily, while those in the control group will receive matching placebo capsules containing microcrystalline cellulose; both interventions will be administered as add-on therapy for 8 weeks alongside ongoing antidepressant treatment. Clinical assessments will be conducted at baseline and Week 8 using validated rating scales, including MADRS for depressive symptoms, Hamilton Anxiety Rating Scale (HAM-A) for anxiety, Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) for sleep-related outcomes, and Clinical Global Impression scales (CGI-S and CGI-I) for overall clinical status. Blood samples will be collected at baseline and follow-up for estimation of serum magnesium, glycine, and brain-derived neurotrophic factor (BDNF). Treatment-emergent adverse events will be actively monitored throughout the study, with severity and causality assessed using standardized pharmacovigilance tools. Statistical analyses will compare changes from baseline to Week 8 between study groups, with change in MADRS score serving as the primary efficacy endpoint.

Being tested
Magnesium Bisglycinate, Microcrystalline cellulose
Medical subject headings
Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnesium BisglycinateDietary supplement

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

  • 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.

Study groups in NCT07633080
Study groupRoleWhat they receive
Control armPlacebo comparatorThe control arm will receive an add-on placebo (microcrystalline cellulose capsules) once daily along with Standard of care (SSRI/SNRI) for 8 weeks.
Receives: Other: Microcrystalline cellulose
Test armExperimentalThe 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.
Receives: Dietary Supplement: Magnesium Bisglycinate

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (9)

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

    The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered instrument used to assess the severity of anxiety symptoms. It consists of 14 items, each scored from 0 (absent) to 4 (very severe), yielding a total score ranging from 0 to 56, with higher scores indicating greater anxiety severity. HAM-A scores are commonly interpreted as <17 (mild anxiety), 18-24 (mild-to-moderate anxiety), 25-30 (moderate-to-severe anxiety), and >30 (severe anxiety).

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

  2. Change in Pittsburgh Sleep Quality Index (PSQI) score

    The Pittsburgh Sleep Quality Index (PSQI) is a validated self-administered questionnaire used to assess sleep quality and sleep disturbances over the previous month. It consists of 19 items that generate seven component scores, which are summed to produce a global score ranging from 0 to 21, with higher scores indicating poorer sleep quality. A global PSQI score of ≤5 is generally considered indicative of good sleep quality, whereas a score >5 suggests clinically significant sleep disturbance or poor sleep quality.

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

  3. Change in Epworth Sleepiness Scale (ESS) score

    The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire used to measure a person's general level of daytime sleepiness and the likelihood of falling asleep in common daily situations. It consists of 8 items, each scored from 0 (would never doze) to 3 (high chance of dozing), resulting in a total score ranging from 0 to 24, with higher scores indicating greater daytime sleepiness. ESS scores are commonly interpreted as 0-10 (normal daytime sleepiness), 11-12 (mild excessive daytime sleepiness), 13-15 (moderate excessive daytime sleepiness), and 16-24 (severe excessive daytime sleepiness).

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

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

    The Clinical Global Impression-Severity (CGI-S) scale is a clinician-rated instrument used to assess the overall severity of a patient's illness at a specific point in time. It consists of a single item scored on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients), with higher scores indicating greater illness severity. CGI-S scores are commonly interpreted as 1 (normal), 2 (borderline ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), and 7 (among the most extremely ill patients).

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

  5. Clinical Global Impression Improvement (CGI-I)

    The Clinical Global Impression-Improvement (CGI-I) scale is a clinician-rated instrument used to assess the degree of change in a patient's clinical condition relative to baseline following treatment. It consists of a single item scored on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), with lower scores indicating greater clinical improvement. CGI-I scores are interpreted as 1 (very much improved), 2 (much improved), 3 (minimally improved), 4 (no change), 5 (minimally worse), 6 (much worse), and 7 (very much worse).

    Measured: Week 8

  6. Change in serum brain-derived neurotrophic factor (BDNF)

    Serum brain-derived neurotrophic factor (BDNF) will be estimated as a biomarker of neuroplasticity and neuronal function. Blood samples collected at baseline and Week 8 will be processed to obtain serum, and BDNF concentrations will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit according to the manufacturer's instructions.

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

  7. Change in serum magnesium

    Serum magnesium concentration will be estimated as a biochemical marker of magnesium status. Blood samples collected at baseline and Week 8 will be processed to obtain serum, and magnesium levels will be measured using an autoanalyzer.

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

  8. Change in serum glycine

    Blood samples collected at baseline and Week 8 will be processed to obtain serum, and glycine levels will be quantified using a commercially available enzyme-linked immunosorbent assay (ELISA) kit according to the manufacturer's instructions.

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

  9. Incidence of Treatment-emergent adverse events (TEAEs)

    During the telephonic interview at 4 weeks or the follow-up visit at 8 weeks, patients can directly contact the investigators to report any adverse events they experience. Whether previously known or not, all adverse events will be recorded with their descriptions, intensities, durations, actions taken, and outcomes. Treatment-emergent adverse events will be evaluated and managed according to severity using the Hartwig-Siegel scale. Causality assessment will be done for adverse drug reactions by using the WHO-UMC system.

    Measured: week 4 and week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2026
  2. Study start12 Jun 2026
  3. Primary completion12 May 2028 (estimated)
  4. Study completion12 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07633080
Sponsor's protocol ID
IEC/AIIMSBBSR/PGTh/2026-27/01
Acronym
DReAM-BiG
Status last verified
Jun 2026
First submitted
3 Jun 2026
Last updated
15 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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.

    PubMed 31071719

  • 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.

    PubMed 41694045

  • 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.

    PubMed 28791566

  • 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.

    PubMed 38191692

  • 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.

    PubMed 24067405

  • 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.

    PubMed 25027582

  • 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.

    PubMed 38213402

  • 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.

    PubMed 25533534

  • 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.

    PubMed 34111673

  • 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.

    PubMed 40918053

Questions about this trial

What is this clinical trial studying?

A study testing Magnesium Bisglycinate and Microcrystalline cellulose in people with Major Depressive Disorder, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rituparna Maiti, M.D. (9438884191, pharm_rituparna@aiimsbhubaneswar.edu.in), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score (time frame: Baseline (week 0) and follow-up (week 8)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07633080, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.

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