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

• ClinicalTrials.gov Identifier: NCT05950061
• Recruitment Status: Completed
• First Posted: July 18, 2023
• Last Update Posted: July 18, 2023
• Sponsor: KRL Hospital, Islamabad
• Collaborators: Khyber Medical College, Peshawar; Quaid-e-Azam Medical College; Dow University of Health Sciences
• Information provided by (Responsible Party): Hassan Mumtaz, KRL Hospital, Islamabad

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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Sertraline; Sertraline	Drug: Sertraline; Sertraline (200 mg/day) capsule; Other Name: Sertraline pill
Experimental: Escitalopram; Escitalopram	Drug: Escitalopram; Escitalopram (10 mg/day) capsule; Other Name: Escitalopram pill

Outcome Measures

Primary Outcome Measures :

1. Change in clinical global impression (CGI) scale [ Time Frame: 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)
2. Change in Montgomery-Åsberg Depression Rating Scale (MADRS) scale [ Time Frame: 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.
3. Diarrhea [ Time Frame: 4 months ]
   Number of participants with diarrhea
4. Nausea [ Time Frame: 4 months ]
   Number of participants with nausea
5. Sexual dysfunction [ Time Frame: 4 months ]
   Number of participants with sexual dysfunction
6. Upper respiratory tract infection [ Time Frame: 4 months ]
   Number of participants with upper respiratory tract infection

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Pakistan

KRL Hospital

Islamabad, Pakistan

Sponsors and Collaborators

KRL Hospital, Islamabad

Khyber Medical College, Peshawar

Quaid-e-Azam Medical College

Dow University of Health Sciences

Investigators

• Study Director: Hassan Mumtaz, MBBS, MRSPH; KRL Hospital, Islamabad

More Information

• Responsible Party: Hassan Mumtaz, Principal Researcher, KRL Hospital, Islamabad
• ClinicalTrials.gov Identifier: NCT05950061
• Other Study ID Numbers: KRL/02/19/1
• First Posted: July 18, 2023
• Last Update Posted: July 18, 2023
• Last Verified: July 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hassan Mumtaz, KRL Hospital, Islamabad:

Sertraline; Depressive Disorder, Major; Escitalopram; South Asian People; Humans

Additional relevant MeSH terms:

Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders; Behavioral Symptoms; Dexetimide; Citalopram; Sertraline; Escitalopram; Selective Serotonin Reuptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Antiparkinson Agents; Anti-Dyskinesia Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Antidepressive Agents, Second-Generation; Antidepressive Agents; Psychotropic Drugs