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A clinical trial to study the effects of two drugs, viladozone and fluoxetine in major depressive patients for 6 weeks

A 6 week prospective open label comparative study of efficacy and safety of vilazodone and fluoxetine in major depressive disorder

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/03/008202
Enrollment
72
Registered
2017-03-23
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: Tab vilazodone 20-40mg: Tab vilazodone 20-40mg orally,daily morning after food for 6 weeks Control Intervention1: Cap fluoxetine 20-60mg: Cap fluoxetine 20-60mg,orally once daily mornin

Sponsors

Mysore medical college and research institute
Lead Sponsor
Dr Anil Kumar MN
Collaborator
Dr Hema NG
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: •subjects diagnosed with major depressive disorder, first episode (according to DSM -V criteria) or recurrent episodes. •Age: 18-65 years. •Both sexes. •Subjects who give informed consent.

Exclusion criteria

Exclusion criteria: •Severe depressive episode with suicidal/poor insight subject who is unable to give informed consent. •Subjects with any serious concurrent medical and psychiatric illness. •Presence of organic brain syndromes including delirium and dementia.

Design outcomes

Primary

MeasureTime frame
EfficacyTimepoint: Baseline(before medication), 3rd week, 6th week

Secondary

MeasureTime frame
Side effect profileTimepoint: 3rd week and 6th week

Countries

India

Contacts

Public ContactDr Usharani H Patted

Mysore medical college and research institute

dr.hema_ng@yahoo.com9449621172

Outcome results

None listed

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