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

KRL Hospital, Islamabad

Status and phase

Completed

Phase 3

Conditions

Major Depressive Disorder

Treatments

Drug: Escitalopram

Drug: Sertraline

Study type

Interventional

Funder types

Other

Identifiers

NCT05950061

KRL/02/19/1

Details and patient eligibility

About

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.

Full 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.

Enrollment

744 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Eligible participants had to have a score of at least 20 on the MADRS at both screening and baseline visits.
All participants who had moderate or severe depression
Study participants had to have normal results on physical examination, laboratory tests, and electrocardiograms, or any abnormalities had to be clinically insignificant.
Female participants of childbearing potential had to have a negative pregnancy test and be using medically approved contraception.

Exclusion criteria

Lactating women were not eligible to participate.
Individuals with a psychiatric disorder other than MDD
Individuals with a history of any Diagnostic and Statistical Manual -V defined psychotic disorder
Individuals with current diagnosis of bipolar disorder
Individuals with current diagnosis of schizophrenia
Individuals with current diagnosis of obsessive-compulsive disorder
Individuals with intellectual disability
Individuals with a pervasive development disorder.
Participants with current substance abuse or dependency,
Participants with suicidal risk,
Participants with personality disorders that would impede participation in study
Participants were also not eligible to participate if they had used a selective serotonin release inhibitor (SSRI) in the past two weeks (past five weeks if they used fluoxetine).
Participants with Montgomery-Åsberg Depression Rating Scale score of <19.