Health Condition 1: F332- Major depressive disorder, recurrent severe without psychotic features Health Condition 2: F330- Major depressive disorder, recurrent, mild Health Condition 3: F331- Major depressive disorder, recurrent, moderate
Conditions
Interventions
Intervention1: Magnesium bisglycinate (add-on to SSRI/SNRI): Once daily dose of 220 mg elemental magnesium with 1350mg glycine will be prescribed for a period of 8 weeks.
Control Intervention1: Placeb
Sponsors
Dr Rituparna Maiti
Dr Abhishek Akella
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with Major Depressive Disorder as per DSM-5 TR criteria. 2. Mild to sever depression, defined as baseline MADRS score more than or equal to 7. 3. Currently receiving a stable dose of anti-depressant monotherapy(SSRI or SNRI) in equivalent doses. 4. Willing and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity to magnesium 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. Patients with substance use disorder (except nicotine, alcohol and caffeine), as per DSM-5 criteria. 6. Concurrent use of magnesium-containing supplements, antacids, or laxatives. 7. History of significant severe medical comorbidity, including uncontrolled hypothyroidism, Cushing s syndrome, active malignancy, myasthenia gravis, or severe hepatic impairment. 8. Use of medications with significant interactions with magnesium (e.g., tetracyclines, fluoroquinolones, bisphosphonates, diuretics) that cannot be temporally separated by more than or equal to 2 hours. 9. Electroconvulsive therapy (ECT) received within the past 3 months. 10. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in severity of depressive symptoms, as measured by Montgomery sberg Depression Rating Scale (MADRS) total score, from baseline (Week 0) to follow-up (Week 8) between the study groupsTimepoint: Baseline (Week 0) and follow-up (Week 8). | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate and compare the change in severity of anxiety symptoms, as measured by the Hamilton Anxiety Rating Scale (HAM-A) total score, from baseline to 8-week follow-up, between the study groups.Timepoint: Baseline (Week 0) and follow-up (Week 8).;To evaluate and compare the change in sleep quality and daytime sleepiness, as measured by the Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS) scores, respectively, from baseline to 8-week follow-up, between the study groups.Timepoint: Baseline (Week 0) and follow-up (Week 8).;To evaluate and compare clinical status in terms of severity and improvement, as assessed by the Clinical Global Impressions - Severity (CGI-S) and Clinical Global Impressions - Improvement (CGI-I) scores, respectivelyTimepoint: Baseline (Week 0) and follow-up (Week 8).;To compare the change in serum Brain-Derived Neurotrophic Factor (BDNF) levels from baseline to Week 8 between the study groups and explore correlations with the change in clinical parameters.Timepoint: Baseline (Week 0) and follow-up (Week 8).;To compare the change in serum magnesium levels from baseline to Week 8 between the study groupsTimepoint: Baseline (Week 0) and follow-up (Week 8).;To compare the change in serum glycine levels from baseline to Week 8 between the study groupsTimepoint: Baseline (Week 0) and follow-up (Week 8).;To evaluate and compare the treatment-emergent adverse events between the study groups.Timepoint: Week 4 and Week 8 | — |
Countries
India
Contacts
Public ContactDr Abhishek Akella
All India Institute of Medical Sciences, Bhubaneswar.
Outcome results
None listed