NCT05950061

Sertraline Versus Escitalopram in South Asian Participants With Moderate to Severe Major Depressive Disorder

Sertraline Versus Escitalopram in South Asian Participants With Moderate to Severe Major Depressive Disorder: A Double-blind, Parallel, Randomized Controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 744 (actual)
• Sponsor: KRL Hospital, Islamabad · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Objective: The aim of this randomized controlled trial was to compare the efficacy and safety of sertraline and escitalopram in participants with moderate to severe major depressive disorder (MDD). Methods: A total of 744 participants with moderate to severe MDD were randomly assigned to receive either sertraline or escitalopram for 8 weeks. Drug dosages and titration schedules were based on the recommendations of the prescribing information for each product and according to the judgment of the clinicians involved in the study. The primary outcome measures were changes from baseline on the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Clinical Global Impression (CGI) scale as well as frequency of adverse events in both groups.

Detailed description

This is a monocentric, double-blind, parallel, randomized controlled trial conducted in Khan Research Laboratories (KRL) hospital, Islamabad, Pakistan for a total period of 16 weeks. By employing appropriate measures to ensure adequate allocation concealment, thereby minimizing the potential for selection bias in the assignment of participants to treatment groups, the investigators studied if there was any significant difference in in efficacy and tolerability of oral sertraline (50 - 200 mg/day) and oral escitalopram (10 mg/day) given either at night or during the day in the South Asian population for the treatment of moderate to severe major depressive disorder (MDD). 744 South Asian patients with moderate to severe MDD as per the Montgomery-Asberg Depression Rating Scale (MADRS) scale who had consented to participate in the trial and who fulfilled the inclusion criteria were included in our study. The study was conducted at KRL hospital.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Sertraline	Sertraline (200 mg/day) capsule
DRUG	Escitalopram	Escitalopram (10 mg/day) capsule

Timeline

• Start date: 2022-06-01
• Primary completion: 2022-10-29
• Completion: 2023-02-26
• First posted: 2023-07-18
• Last updated: 2023-07-18

Locations

1 site across 1 country: Pakistan