Magnesium Bisglycinate in Major Depressive Disorder
ConditionMajor Depressive Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAll India Institute of Medical Sciences, Bhubaneswar
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Magnesium Bisglycinate
Dietary supplementMagnesium Bisglycinate (220 mg elemental mangnesium and 1350 mg glycine) per day for 8 weeks
Microcrystalline cellulose
Other interventionThe 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.
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Control armPlacebo comparator 1 intervention
Group B: Test armExperimental treatment 1 intervention
Trial outcomes
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).
Time frame
Baseline (week 0) and follow-up (week 8)Secondary outcomes
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).
Time frame
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.
Time frame
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).
Time frame
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).
Time frame
Baseline (week 0) and follow-up (week 8)Sponsors and contacts
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Source ClinicalTrials.gov