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

Sponsor

KRL Hospital, Islamabad (Other)

Overall Status

Completed

CT.gov ID

NCT05950061

Collaborator

Khyber Medical College, Peshawar (Other), Quaid-e-Azam Medical College (Other), Dow University of Health Sciences (Other)

744

Enrollment

Location

Arms

8.9

Actual Duration (Months)

83.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: Sertraline Drug: Escitalopram	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

744 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2022

Actual Primary Completion Date :

Oct 29, 2022

Actual Study Completion Date :

Feb 26, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sertraline Sertraline	Drug: Sertraline Sertraline (200 mg/day) capsule Other Names: Sertraline pill
Experimental: Escitalopram Escitalopram	Drug: Escitalopram Escitalopram (10 mg/day) capsule Other Names: Escitalopram pill

Arm

Intervention/Treatment

Experimental: Sertraline

Sertraline

Drug: Sertraline

Sertraline (200 mg/day) capsule

Other Names:

Sertraline pill

Experimental: Escitalopram

Escitalopram

Drug: Escitalopram

Escitalopram (10 mg/day) capsule

Other Names:

Escitalopram pill

Outcome Measures

Primary Outcome Measures

Change in clinical global impression (CGI) scale [4 months]
Change in the clinical global impression scale. CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill)
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) scale [4 months]
Change in Montgomery-Åsberg Depression Rating Scale from baseline. The MADRS (Montgomery & Åsberg, 1979) comprises the following 10 items: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Clinicians rate each item on a 7-point Likert scale; the sum of the item scores produces a MADRS total score that ranges from 0 to 60, with higher scores reflecting greater depression severity.
Diarrhea [4 months]
Number of participants with diarrhea
Nausea [4 months]
Number of participants with nausea
Sexual dysfunction [4 months]
Number of participants with sexual dysfunction
Upper respiratory tract infection [4 months]
Number of participants with upper respiratory tract infection

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.