A phase-III clinical trial to to compare the effects of Vilazodone versus escitalopram in patients with depression.
Phase 4
- Conditions
- Health Condition 1: F321- Major depressive disorder, singleepisode, moderate
- Registration Number
- CTRI/2020/07/026520
- Lead Sponsor
- Dr P N Suresh Kumar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1 Age more than 18 and less than 65 years.
2 No antidepressant and antipsychotic exposure for the past 2 months.
Exclusion Criteria
1 Other co-morbid psychiatric disorders.
2 Pregnancy and lactation.
3 Concurrent major life-threatening illness like malignancy, cardiac failure, renal failure etc.
4 Suicidal patients.
5 Alcohol and substance abuse and smokers.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method endpoint (4 week) Hamilton Depression rating scale-17 scoresTimepoint: At baseline, and at the two week and four week follow up time points.
- Secondary Outcome Measures
Name Time Method Secondary outcomes included rater blinded endpoint scores on MADRS and CGI-S as well as proportion reporting treatment emergent side effects (diarrhoea, sexual dysfunction and weight gain) at study endpoint.Timepoint: at baseline, and at the two week and four week follow up time points.