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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Sertraline; Drug: Escitalopram

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 Type: Interventional
• Enrollment (Actual): 744
• Phase: Phase 3

Contacts and Locations

Study Locations

• Pakistan
  • Islamabad, Pakistan
    • KRL Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in clinical global impression (CGI) scale	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)	4 months
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) scale	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.	4 months
Diarrhea	Number of participants with diarrhea	4 months
Nausea	Number of participants with nausea	4 months
Sexual dysfunction	Number of participants with sexual dysfunction	4 months
Upper respiratory tract infection	Number of participants with upper respiratory tract infection	4 months

Collaborators and Investigators

• Sponsor: KRL Hospital, Islamabad
• Collaborators: Dow University of Health Sciences; Khyber Medical College, Peshawar; Quaid-e-Azam Medical College
• Investigators: Study Director: Hassan Mumtaz, MBBS, MRSPH, KRL Hospital, Islamabad

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): October 29, 2022
• Study Completion (Actual): February 26, 2023

Study Registration Dates

• First Submitted: June 30, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 18, 2023

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Humans; Sertraline; Depressive Disorder, Major; Escitalopram; South Asian People
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Antidepressive Agents, Second-Generation; Antiparkinson Agents; Anti-Dyskinesia Agents; Selective Serotonin Reuptake Inhibitors; Sertraline; Citalopram; Dexetimide; Escitalopram
• Other Study ID Numbers: KRL/02/19/1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No