Clinical trial NCT05950061: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorder
Keywords: Sertraline
Depressive Disorder, Major
Escitalopram
South Asian People
Humans
Lead sponsor: KRL Hospital, Islamabad
Sponsor class: OTHER
Collaborators: name: Khyber Medical College, Peshawar
name: Quaid-e-Azam Medical College
name: Dow University of Health Sciences
First posted: 2023-07-18
Enrollment: 744
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in clinical global impression (CGI) scale
timeFrame: 4 months
measure: Change in Montgomery-Åsberg Depression Rating Scale (MADRS) scale
timeFrame: 4 months
measure: Diarrhea
timeFrame: 4 months
measure: Nausea
timeFrame: 4 months
measure: Sexual dysfunction
timeFrame: 4 months
measure: Upper respiratory tract infection
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: KRL Hospital
Study officials:
affiliation: KRL Hospital, Islamabad
name: Hassan Mumtaz, MBBS, MRSPH
role: STUDY_DIRECTOR
References: