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

NCT05950061 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 744

Last updated 2023-07-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Sertraline

Sertraline (200 mg/day) capsule

DRUG

Escitalopram

Escitalopram (10 mg/day) capsule

Sponsors & Collaborators

  • Khyber Medical College, Peshawar

    collaborator OTHER

  • Quaid-e-Azam Medical College

    collaborator OTHER

  • Dow University of Health Sciences

    collaborator OTHER

  • KRL Hospital, Islamabad

    lead OTHER

Principal Investigators

  • Hassan Mumtaz, MBBS, MRSPH · KRL Hospital, Islamabad

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05950061 on ClinicalTrials.gov