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Comparison of efficacy and safety of Vilazodone,Escitalopram and Amitriptyline in patients of depression

Comparative evaluation of efficacy and tolerability of Vilazodone, Escitalopram and Amitriptyline in patients of major depressive disorder: a randomized, parallel, open-label clinical study

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/10/010284
Enrollment
60
Registered
2017-10-31
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- MAJOR DEPRESSIVE DISORDER

Interventions

Intervention1: Vilazodone: Tab Vilazodone 20 mg daily for 12 weeks Control Intervention1: Escitalopram: Tab Escitalopram 20 mg daily for 12 weeks Control Intervention2: Amitriptyline: Tab Amitriptylin

Sponsors

Dr Renuka Kadam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: i)Newly diagnosed patients of major depressive disorder (as per Diagnostic and Statistical Manual of Mental Disorder, edition V) ii)Hamilton Depression Rating Score(HAMD-17) >= 22 iii)Aged between 18-60 years iv)Either gender

Exclusion criteria

Exclusion criteria: i)Pregnant and lactating women ii)Women of reproductive age group who are not practicing a reliable method of contraception iii)Patients of severe depression who may not respond to pharmacotherapy alone in the opinion of the psychiatrist iv)Treatment with electroconvulsive therapy within 3 months v)Any other psychiatric disorders except generalized anxiety disorder vi)Abnormal renal/hepatic function vii)Patients requiring other psychotropic medications, central nervous system active drugs viii)Patients on drug therapy for any other systemic disorder ix)Patients who have taken an investigational drug or participated in an investigational drug trial within the past 30 days

Design outcomes

Primary

MeasureTime frame
Change in score on the hamilton depression rating scale from baseline to week 12Timepoint: Baseline 2 weeks 4 weeks 12 weeks

Secondary

MeasureTime frame
1) Change in score on the montgomery asberg depression rating scale (madrs) from baseline to week 12 2)Change in score on the hamilton anxiety rating scale (ham-a) from baseline to week 12 3)To compare tolerability of vilazodone with escitalopram & amitriptyline, in patients of major depressive disorder Timepoint: Baseline 2 weeks 4 weeks 12 weeks

Countries

India

Contacts

Public ContactDr Renuka Kadam

Government Medical College and Hospital Nagpur

smitaavanti@yahoo.co.in9923597661

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026