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

NCT05950061 | Completed Phase 3 DMC

• 1 other identifier: KRL/02/19/1
• Study Type: interventional
• Target: 744
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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)

  4 months

• 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.

  4 months

• Diarrhea

  Number of participants with diarrhea

  4 months

• Nausea

  Number of participants with nausea

  4 months

• Sexual dysfunction

  Number of participants with sexual dysfunction

  4 months

• Upper respiratory tract infection

  Number of participants with upper respiratory tract infection

  4 months

Study Arms (2)

Sertraline

EXPERIMENTAL

Sertraline

Drug: Sertraline

Escitalopram

EXPERIMENTAL

Escitalopram

Drug: Escitalopram

Interventions

Sertraline DRUG

Sertraline (200 mg/day) capsule

Also known as: Sertraline pill

Sertraline

Escitalopram DRUG

Escitalopram (10 mg/day) capsule

Also known as: Escitalopram pill

Escitalopram

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• KRL Hospital, Islamabad: lead
• Khyber Medical College, Peshawar: collaborator
• Quaid-e-Azam Medical College: collaborator
• Dow University of Health Sciences: collaborator

Study Sites (1)

KRL Hospital

Islamabad, Pakistan

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Sertraline; Escitalopram

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Propylamines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Hassan Mumtaz, MBBS, MRSPH

  KRL Hospital, Islamabad

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Researcher

Study Record Dates

• First Submitted: June 30, 2023
• First Posted: July 18, 2023
• Study Start: June 1, 2022
• Primary Completion: October 29, 2022
• Study Completion: February 26, 2023
• Last Updated: July 18, 2023

Record last verified: 2023-07

Locations

PA (1)