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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
India
All India Institute of Medical Sciences (AIIMS)
RECRUITING
Bhubaneswar
Contact Information
Primary
Rituparna Maiti, M.D.
pharm_rituparna@aiimsbhubaneswar.edu.in
9438884191
Time Frame
Start Date: 2026-06-12
Estimated Completion Date: 2028-06-12
Participants
Target number of participants: 84
Treatments
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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: All India Institute of Medical Sciences, Bhubaneswar

This content was sourced from clinicaltrials.gov