A study on silymarin (a medicine from plant) on special indicators present in blood (inflammatory cytokines and genetic markers) and in reducing the problems associated with depression in patients suffering from depressive disorder

Not Applicable

Conditions: Health Condition 1: F32- Major depressive disorder, singleepisode

Registration Number: CTRI/2019/07/020010

Lead Sponsor: JIPMER Dhanvantari nagar Gorimedu Puducherry

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Yet Recruiting

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.Newly diagnosed drug naÃ¯ve 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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in Hamilton depression rating scale (HAM-D) scoresTimepoint: Baseline, 3rd, 6th, 9th & 12th weeks of intervention

Secondary Outcome Measures

Name	Time	Method
Biochemical Parameters <br/ ><br>Inflammatory Cytokines <br/ ><br>miRNAs <br/ ><br>Total-Oxidants <br/ ><br>Total-AntioxidantsTimepoint: Baseline, 6th & 12th weeks of intervention <br/ ><br>;Clinical Global Impression (CGI) <br/ ><br>Pill Count <br/ ><br>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