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

NCT ID: NCT05950061

Last Updated: 2023-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 744 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2023-02-26

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.

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sertraline

Sertraline

Group Type: EXPERIMENTAL

Sertraline

Intervention Type: DRUG

Sertraline (200 mg/day) capsule

Escitalopram

Escitalopram

Group Type: EXPERIMENTAL

Escitalopram

Intervention Type: DRUG

Escitalopram (10 mg/day) capsule

Interventions

Sertraline

Sertraline (200 mg/day) capsule

Intervention Type: DRUG

Escitalopram

Escitalopram (10 mg/day) capsule

Intervention Type: DRUG

Other Intervention Names

Sertraline pill; Escitalopram pill

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Khyber Medical College, Peshawar

OTHER

Sponsor Role: collaborator

Quaid-e-Azam Medical College

OTHER

Sponsor Role: collaborator

Dow University of Health Sciences

OTHER

Sponsor Role: collaborator

KRL Hospital, Islamabad

OTHER

Sponsor Role: lead

Responsible Party

Hassan Mumtaz

Principal Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hassan Mumtaz, MBBS, MRSPH

Role: STUDY_DIRECTOR

KRL Hospital, Islamabad

Locations

KRL Hospital

Islamabad, , Pakistan

Countries

Pakistan

Other Identifiers

KRL/02/19/1

Identifier Type: -

Identifier Source: org_study_id