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Magnesium Bisglycinate in Major Depressive Disorder (DReAM-BiG)

2026. június 12. frissítette: RITUPARNA MAITI, All India Institute of Medical Sciences, Bhubaneswar

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.

A tanulmány áttekintése

Állapot

Toborzás

Körülmények

Beavatkozás / kezelés

Részletes leírás

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.

Tanulmány típusa

Beavatkozó

Beiratkozás (Becsült)

84

Fázis

  • Nem alkalmazható

Kapcsolatok és helyek

Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.

Tanulmányi kapcsolat

Tanulmányi helyek

  • India
    • Odisha
      • Bhubaneswar, Odisha, India, 751019
        • Toborzás
        • All India Institute of Medical Sciences (AIIMS)
        • Kapcsolatba lépni:
        • Kapcsolatba lépni:

Részvételi kritériumok

A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.

Jogosultsági kritériumok

Tanulmányozható életkorok

  • Felnőtt
  • Idősebb felnőtt

Egészséges önkénteseket fogad

Nem

Leírás

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.

Tanulási terv

Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.

Hogyan készül a tanulmány?

Tervezési részletek

  • Elsődleges cél: Kezelés
  • Kiosztás: Véletlenszerűsített
  • Beavatkozó modell: Párhuzamos hozzárendelés
  • Maszkolás: Hármas

Fegyverek és beavatkozások

Résztvevő csoport / kar
Beavatkozás / kezelés
Placebo Comparator: Control arm
The control arm will receive an add-on placebo (microcrystalline cellulose capsules) once daily along with Standard of care (SSRI/SNRI) for 8 weeks.
Egyéb: 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.
Kísérleti: Test arm
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.
Étrend-kiegészítő: Magnesium Bisglycinate
Magnesium Bisglycinate (220 mg elemental mangnesium and 1350 mg glycine) per day for 8 weeks

Mit mér a tanulmány?

Elsődleges eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score
Időkeret: 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).
Baseline (week 0) and follow-up (week 8)

Másodlagos eredményintézkedések

Eredménymérő
Intézkedés leírása
Időkeret
Change in Hamilton Anxiety Rating Scale (HAM-A) score
Időkeret: Baseline (week 0) and follow-up (week 8)
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).
Baseline (week 0) and follow-up (week 8)
Change in Pittsburgh Sleep Quality Index (PSQI) score
Időkeret: Baseline (week 0) and follow-up (week 8)
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.
Baseline (week 0) and follow-up (week 8)
Change in Epworth Sleepiness Scale (ESS) score
Időkeret: Baseline (week 0) and follow-up (week 8)
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).
Baseline (week 0) and follow-up (week 8)
Change in Clinical Global Impression Severity (CGI-S) score
Időkeret: Baseline (week 0) and follow-up (week 8)
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).
Baseline (week 0) and follow-up (week 8)
Clinical Global Impression Improvement (CGI-I)
Időkeret: Week 8
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).
Week 8
Change in serum brain-derived neurotrophic factor (BDNF)
Időkeret: Baseline (week 0) and follow-up (week 8)
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.
Baseline (week 0) and follow-up (week 8)
Change in serum magnesium
Időkeret: Baseline (week 0) and follow-up (week 8)
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.
Baseline (week 0) and follow-up (week 8)
Change in serum glycine
Időkeret: Baseline (week 0) and follow-up (week 8)
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.
Baseline (week 0) and follow-up (week 8)
Incidence of Treatment-emergent adverse events (TEAEs)
Időkeret: week 4 and week 8
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.
week 4 and week 8

Együttműködők és nyomozók

Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.

Szponzor

All India Institute of Medical Sciences, Bhubaneswar

Nyomozók

  • Tanulmányi szék: Debasish Hota, D.M., AIIMS, Bhubaneswar

Publikációk és hasznos linkek

A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.

Általános kiadványok

Tanulmányi rekorddátumok

Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.

Tanulmány főbb dátumok

Tanulmány kezdete (Tényleges)

2026. június 12.

Elsődleges befejezés (Becsült)

2028. május 12.

A tanulmány befejezése (Becsült)

2028. június 12.

Tanulmányi regisztráció dátumai

Először benyújtva

2026. június 3.

Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak

2026. június 3.

Első közzététel (Tényleges)

2026. június 8.

Tanulmányi rekordok frissítései

Utolsó frissítés közzétéve (Tényleges)

2026. június 15.

Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak

2026. június 12.

Utolsó ellenőrzés

2026. június 1.

Több információ

A tanulmányhoz kapcsolódó kifejezések

További vonatkozó MeSH feltételek

Egyéb vizsgálati azonosító számok

  • IEC/AIIMSBBSR/PGTh/2026-27/01

Terv az egyéni résztvevői adatokhoz (IPD)

Tervezi megosztani az egyéni résztvevői adatokat (IPD)?

NEM

IPD terv leírása

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.

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