drugset
drugset / Trial / NCT05950061

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

NCT05950061 ↗

Phase 3 Completed 744 enrolled KRL Hospital, Islamabad Dow University of Health Sciences · collabKhyber Medical College, Peshawar · collabQuaid-e-Azam Medical College · collab
RandomizedParallel-groupDouble-blindTreatment

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.

Timeline

Start
2022-06-01
Primary completion
2022-10-29
Completion
2023-02-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Escitalopram Small molecule 10 mg Oral
Subject Sertraline Small molecule 200 mg Oral

Indications

major depressive disorder