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Completed

NCT Number: NCT05950061

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

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

KRL Hospital

Islamabad, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sertraline

Drug

Sertraline (200 mg/day) capsule

Other names: Sertraline pill

Escitalopram

Drug

Escitalopram (10 mg/day) capsule

Other names: Escitalopram pill

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

KRL Hospital, Islamabad

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Jul 18, 2023
Registry last updated
Jul 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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