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

Tracking Information

• First Submitted Date: June 30, 2023
• First Posted Date: July 18, 2023
• Last Update Posted Date: July 18, 2023
• Actual Study Start Date: June 1, 2022
• Actual Primary Completion Date: October 29, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 14, 2023)

• 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)
• 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.
• Diarrhea [ Time Frame: 4 months ]
  Number of participants with diarrhea
• Nausea [ Time Frame: 4 months ]
  Number of participants with nausea
• Sexual dysfunction [ Time Frame: 4 months ]
  Number of participants with sexual dysfunction
• Upper respiratory tract infection [ Time Frame: 4 months ]
  Number of participants with upper respiratory tract infection

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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.
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Major Depressive Disorder

Intervention

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

Study Arms

• Experimental: Sertraline
  Sertraline
  Intervention: Drug: Sertraline
• Experimental: Escitalopram
  Escitalopram
  Intervention: Drug: Escitalopram

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 14, 2023): 744
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: February 26, 2023
• Actual Primary Completion Date: October 29, 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Pakistan

Administrative Information

• NCT Number: NCT05950061
• Other Study ID Numbers: KRL/02/19/1
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Hassan Mumtaz, KRL Hospital, Islamabad
• Original Responsible Party: Same as current
• Current Study Sponsor: KRL Hospital, Islamabad
• Original Study Sponsor: Same as current

Collaborators

• Khyber Medical College, Peshawar
• Quaid-e-Azam Medical College
• Dow University of Health Sciences

Investigators

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

• PRS Account: KRL Hospital, Islamabad
• Verification Date: July 2023