search
Back to results

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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 3
Locations
Pakistan
Study Type
Interventional
Intervention
Sertraline
Escitalopram
Sponsored by
KRL Hospital, Islamabad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Sertraline, Depressive Disorder, Major, Escitalopram, South Asian People, Humans

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • KRL Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sertraline

Escitalopram

Arm Description

Sertraline

Escitalopram

Outcomes

Primary Outcome Measures

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)
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.
Diarrhea
Number of participants with diarrhea
Nausea
Number of participants with nausea
Sexual dysfunction
Number of participants with sexual dysfunction
Upper respiratory tract infection
Number of participants with upper respiratory tract infection

Secondary Outcome Measures

Full Information

First Posted
June 30, 2023
Last Updated
July 14, 2023
Sponsor
KRL Hospital, Islamabad
Collaborators
Khyber Medical College, Peshawar, Quaid-e-Azam Medical College, Dow University of Health Sciences
search

1. Study Identification

Unique Protocol Identification Number
NCT05950061
Brief Title
Sertraline Versus Escitalopram in South Asian Participants With Moderate to Severe Major Depressive Disorder
Official Title
Sertraline Versus Escitalopram in South Asian Participants With Moderate to Severe Major Depressive Disorder: A Double-blind, Parallel, Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
October 29, 2022 (Actual)
Study Completion Date
February 26, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KRL Hospital, Islamabad
Collaborators
Khyber Medical College, Peshawar, Quaid-e-Azam Medical College, Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Sertraline, Depressive Disorder, Major, Escitalopram, South Asian People, Humans

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
744 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sertraline
Arm Type
Experimental
Arm Description
Sertraline
Arm Title
Escitalopram
Arm Type
Experimental
Arm Description
Escitalopram
Intervention Type
Drug
Intervention Name(s)
Sertraline
Other Intervention Name(s)
Sertraline pill
Intervention Description
Sertraline (200 mg/day) capsule
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Escitalopram pill
Intervention Description
Escitalopram (10 mg/day) capsule
Primary Outcome Measure Information:
Title
Change in clinical global impression (CGI) scale
Description
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)
Time Frame
4 months
Title
Change in Montgomery-Åsberg Depression Rating Scale (MADRS) scale
Description
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.
Time Frame
4 months
Title
Diarrhea
Description
Number of participants with diarrhea
Time Frame
4 months
Title
Nausea
Description
Number of participants with nausea
Time Frame
4 months
Title
Sexual dysfunction
Description
Number of participants with sexual dysfunction
Time Frame
4 months
Title
Upper respiratory tract infection
Description
Number of participants with upper respiratory tract infection
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Mumtaz, MBBS, MRSPH
Organizational Affiliation
KRL Hospital, Islamabad
Official's Role
Study Director
Facility Information:
Facility Name
KRL Hospital
City
Islamabad
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs