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Exploration of efficacy and safety of participants exposed to Vortioxetine and Escitalopram for Major Depressive order patients.

A Comparative Study of Efficacy and Safety of Vortioxetine with Escitalopram in Patients of Major Depressive Disorder at Tertiary Care Hospital - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/066519
Enrollment
88
Registered
2024-04-30
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Health Condition 1: F339- Major depressive disorder, recurrent, unspecified

Interventions

Intervention1: vortioxetine and Escitalopram: oral route of administration dosage vortioxetine 10mg,escitalopram 5mg frequency at 2nd,4th,8th and 12th week Control Intervention1: vortioxetine with esc

Sponsors

nil
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Adult Patients (18-65 years old) diagnosed with MDD based on DSM-5 criteria. 2) Patients Presenting to the tertiary Care Hospital outpatient Department with moderate to severe symptoms. 3) Willingness to Provide informed consent for participation in the study.

Exclusion criteria

Exclusion criteria: •Patients with a history of bipolar disorder, psychotic disorder, or substance abuse within the past six months. •Concurrent use of other antidepressants or psychotropic medications. •Patients with previous depression resistant to antidepressants and those who had taken treatment with ECT in previous 3 months or formal psychotherapy within 1 month. •Pregnancy or lactation. •Patients with drug intake for psychosis or anxiety. •Any history of allergy to the drugs.

Design outcomes

Primary

MeasureTime frame
The Proportion of Participants achieving HAM D score of 7 at 12 weeks with vortioxetine vs escitalopramTimepoint: Till 12 weeks

Secondary

MeasureTime frame
1 To assess the safety & tolerability profiles of vortioxetine & escitalopram. 2 To explore any demographic or clinical factors that may influence treatment response. Timepoint: till 12 weeks

Countries

India

Contacts

Public ContactDr Vinod Shivajirao Deshmukh

Vilasrao Deshmukh Government Medical College

vinod_deshmukh88@yahoo.com9405102432

Outcome results

None listed

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