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A phase-III clinical trial to to compare the effects of Vilazodone versus escitalopram in patients with depression.

An open-label randomized pilot study to compare the efficacy and adverse effects of vilazodone versus escitalopram in major depression

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/07/026520
Enrollment
60
Registered
2020-07-13
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: F321- Major depressive disorder, singleepisode, moderate

Interventions

Intervention1: vilazodone 20-60mg: Dose of vilazodone drugs was titrated to a maximum permissible dose 20-60mg per day Control Intervention1: Escitalopram 10-30mg: Dose of Escitalopram was titrated to

Sponsors

Dr P N Suresh Kumar
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
endpoint (4 week) Hamilton Depression rating scale-17 scoresTimepoint: At baseline, and at the two week and four week follow up time points.

Secondary

MeasureTime frame
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.

Countries

India

Contacts

Public ContactDr P N Suresh Kumar

IQRAA psychiatric care and rehabilitation centre

drpnsuresh@gmail.com9447218825

Outcome results

None listed

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