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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05950061
• Other study ID #: KRL/02/19/1
• Status: Completed
• Phase: Phase 3
• Start date: June 1, 2022
• Est. completion date: February 26, 2023

Study information

• Verified date: July 2023
• Source: KRL Hospital, Islamabad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 744
• Est. completion date: February 26, 2023
• Est. primary completion date: October 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Sertraline
Sertraline (200 mg/day) capsule
• Escitalopram
Escitalopram (10 mg/day) capsule

Locations

Country	Name	City	State
Pakistan	KRL Hospital	Islamabad

Sponsors (4)

Lead Sponsor	Collaborator
KRL Hospital, Islamabad	Dow University of Health Sciences, Khyber Medical College, Peshawar, Quaid-e-Azam Medical College

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Diarrhea	Number of participants with diarrhea	4 months
Primary	Nausea	Number of participants with nausea	4 months
Primary	Sexual dysfunction	Number of participants with sexual dysfunction	4 months
Primary	Upper respiratory tract infection	Number of participants with upper respiratory tract infection	4 months