SSRI AND METABOLIC PARAMETERS IN PATIENTS WITH DEPRESSIVE DISORDER
Not Applicable
Completed
- Conditions
- Health Condition 1: F068- Other specified mental disorders due to known physiological conditionHealth Condition 2: F09- Unspecified mental disorder due toknown physiological condition
- Registration Number
- CTRI/2021/07/034892
- Lead Sponsor
- SRIHER D
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 218
Inclusion Criteria
Patients attending the outpatient clinic aged 18 years to 50 years and either gender.
Patients diagnosed with depression as per Diagnostic and Statistical Manual V(DSM V ) criteria by physician
Exclusion Criteria
Pregnant or breast feeding women.
Patients with previous history of hypersensitivity to SSRI and had serotonin syndrome.
Patients with severe depression requiring inpatient admission.
Suicidal behaviour within 30 days before screening.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the effect of Vortioxetine in comparison to Fluoxetine on metabolic parameters in <br/ ><br>depressive disorder by using International Diabetes Federation Scale (IDFS) <br/ ><br>To assess the quality of life using Rand SF-36 QuestionnaireTimepoint: After taking baseline the drug therapy is assessed on 4th week, 8th week and 12th week
- Secondary Outcome Measures
Name Time Method To screen the possible risk for Vortioxetine and Fluoxetine during the study periodTimepoint: 1 year