An interventional study of Magnesium Bisglycinate and Microcrystalline cellulose in Major Depressive Disorder, sponsored by All India Institute of Medical Sciences, Bhubaneswar. Recruiting at 1 site in India. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-06-15.
Sponsored by All India Institute of Medical Sciences, Bhubaneswar · Not applicable, Interventional, and Treatment
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.
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.
3,041 studies on the registry are indexed under Depressive Disorder, Major; 588 are open to participants now.
This study's planned enrollment of 84 is close to the median of 79 across 2,530 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →All India Institute of Medical Sciences, Bhubaneswar is the lead sponsor of 59 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Magnesium Bisglycinate (220 mg elemental mangnesium and 1350 mg glycine) per day for 8 weeks
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.
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).
Time frame: Baseline (week 0) and follow-up (week 8)
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).
Time frame: Baseline (week 0) and follow-up (week 8)
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.
Time frame: Baseline (week 0) and follow-up (week 8)
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).
Time frame: Baseline (week 0) and follow-up (week 8)
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).
Time frame: Baseline (week 0) and follow-up (week 8)
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).
Time frame: Week 8
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.
Time frame: Baseline (week 0) and follow-up (week 8)
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.
Time frame: Baseline (week 0) and follow-up (week 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.
Time frame: Baseline (week 0) and follow-up (week 8)
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.
Time frame: week 4 and week 8
Plan to share: 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.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Magnesium diglycinate
All India Institute of Medical Sciences, Bhubaneswar