NCT07633080 Magnesium Bisglycinate in Major Depressive Disorder
| NCT ID | NCT07633080 |
| Status | Recruiting |
| Phase | — |
| Sponsor | All India Institute of Medical Sciences, Bhubaneswar |
| Condition | Major Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2026-06-12 |
| Primary Completion | 2028-05-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2026-06-12 with a primary completion date of 2028-05-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Debasish Hota, D.M.
STUDY CHAIR
AIIMS, Bhubaneswar
Frequently Asked Questions
Who can join the NCT07633080 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Major Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07633080 currently recruiting?
Yes, NCT07633080 is actively recruiting participants. Contact the research team at pharm_rituparna@aiimsbhubaneswar.edu.in for enrollment information.
Where is the NCT07633080 trial being conducted?
This trial is being conducted at Bhubaneswar, India.
Who is sponsoring the NCT07633080 clinical trial?
NCT07633080 is sponsored by All India Institute of Medical Sciences, Bhubaneswar. The principal investigator is Debasish Hota, D.M. at AIIMS, Bhubaneswar. The trial plans to enroll 84 participants.