Health Condition 1: F32- Major depressive disorder, singleepisode
Conditions
Interventions
Intervention1: Capsule Silymarin: 140 mg three times a day, orally, after food, for 12 weeks.
Control Intervention1: Capsule Placebo: 140 mg three times a day, orally, after food, for 12 weeks.
Sponsors
JIPMER Dhanvantari nagar Gorimedu Puducherry
Eligibility
Inclusion criteria
Inclusion criteria: 1.Newly diagnosed drug naïve patients with the first episode of major depressive disorder as per DSM-5 criteria and additionally confirmed using M.I.N.I plus (Mini international neuropsychiatric interview) and HAM-D (Hamilton depression rating scale) score of > 13 (major depressive disorder). 2.Participants with the age group of 18-65 years of either gender.
Exclusion criteria
Exclusion criteria: 1.H/O suspected organic or substance-induced mood disorder. 2.H/O uncontrolled diabetes (HbA1c > 8), cancer, immunological disorders such as systemic lupus erythematosus, endocrinopathies such as hypothyroidism/hyperthyroidism. 3.Patients who are on NSAIDs, steroids and other immune-modulatory therapies. 4.Patients who are not willing to give consent 5.H/O coronary artery disease, congestive heart failure and arrhythmias. 6.H/O fever/ clinical evidence of active infections or wounds in the last 2 weeks. 7.H/O surgery or burns in the last 1 month. 8.H/O substance abuse. 9.Patients with suicidal tendency, psychotic disorders, mania and hypomania. 10.Pregnant women or lactating mother. 11.Women in a reproductive age group not practicing adequate contraceptive measures. 12.Patients who had participated in other trials in the past three months. 13.Patients on herbal medications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in Hamilton depression rating scale (HAM-D) scoresTimepoint: Baseline, 3rd, 6th, 9th & 12th weeks of intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Biochemical Parameters Inflammatory Cytokines miRNAs Total-Oxidants Total-AntioxidantsTimepoint: Baseline, 6th & 12th weeks of intervention ;Clinical Global Impression (CGI) Pill Count Medication Adherence Rating Scale (MARS)Timepoint: Baseline, 3rd, 6th, 9th & 12th week of intervention;Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF)Timepoint: Baseline & 12th week of intervention | — |
Countries
India
Contacts
Public ContactDr Harivenkatesh Natarajan
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Outcome results
None listed