A Phase 3 interventional study of Sertraline and Escitalopram in Major Depressive Disorder, sponsored by KRL Hospital, Islamabad. Completed at 1 site in Pakistan. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-07-18.
Sponsored by KRL Hospital, Islamabad · Phase 3, Interventional, and Treatment
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.
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.
2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.
This study's enrollment of 744 is above the median of 80 across 2,338 interventional studies indexed under Depressive Disorder, Major.
Browse Depressive Disorder, Major studies →KRL Hospital, Islamabad is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Sertraline
Drug: Sertraline
Escitalopram
Drug: Escitalopram
Sertraline (200 mg/day) capsule
Also known as: Sertraline pill
Escitalopram (10 mg/day) capsule
Also known as: Escitalopram pill
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)
Time frame: 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.
Time frame: 4 months
Diarrhea
Number of participants with diarrhea
Time frame: 4 months
Nausea
Number of participants with nausea
Time frame: 4 months
Sexual dysfunction
Number of participants with sexual dysfunction
Time frame: 4 months
Upper respiratory tract infection
Number of participants with upper respiratory tract infection
Time frame: 4 months
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from Jun 2022 to primary completion in Oct 2022, 4 months.
Of 122 phase 3 interventional studies under Depressive Disorder, Major, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 36. This study's 4 months is below that.
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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Sertraline · Escitalopram
KRL Hospital, Islamabad