Major Depressive DisorderPhase 3NCT05950061
Sertraline Versus Escitalopram in South Asian Participants With Moderate to Severe Major Depressive Disorder
A Phase 3 study testing Sertraline and Escitalopram in people with Major Depressive Disorder, run by KRL Hospital, Islamabad at 1 site in Pakistan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Sertraline and Escitalopram
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 744 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2022to 26 Feb 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sertraline Versus Escitalopram in South Asian Participants With Moderate to Severe Major Depressive Disorder: A Double-blind, Parallel, Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Major Depressive Disorder
- Being tested
- Sertraline, Escitalopram
- Keywords
- Sertraline, Depressive Disorder, Major, Escitalopram, South Asian People, Humans
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Also called Sertraline pill
Sertraline (200 mg/day) capsule
EscitalopramDrug
Also called Escitalopram pill
Escitalopram (10 mg/day) capsule
| Study group | Role | What they receive |
|---|---|---|
| Sertraline | Experimental | Sertraline Receives: Drug: Sertraline |
| Escitalopram | Experimental | Escitalopram Receives: Drug: Escitalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 4 months
Diarrhea
Number of participants with diarrhea
Measured: 4 months
Nausea
Number of participants with nausea
Measured: 4 months
Sexual dysfunction
Number of participants with sexual dysfunction
Measured: 4 months
Upper respiratory tract infection
Number of participants with upper respiratory tract infection
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Jun 2022
- Primary completion29 Oct 2022
- Study completion26 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 744 participants (actual)
Sponsor and investigators
- Lead sponsor
- KRL Hospital, Islamabad
- Sponsor type
- University, hospital or other
- Collaborators
- Khyber Medical College, Peshawar, Quaid-e-Azam Medical College, Dow University of Health Sciences
- Responsible party
- Principal investigator, Hassan Mumtaz, KRL Hospital, Islamabad
- Investigators
- Hassan Mumtaz, MBBS, MRSPH, Study director, KRL Hospital, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950061
- Sponsor's protocol ID
- KRL/02/19/1
- Status last verified
- Jul 2023
- First submitted
- 30 Jun 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sertraline Versus Escitalopram in South Asian Participants With Moderate to Severe Major Depressive Disorder: A Double-blind, Parallel, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05950061
- Acronym / sponsor ID
- KRL/02/19/1
- Conditions
- Major Depressive Disorder
- Keywords
- Sertraline, Depressive Disorder, Major, Escitalopram, South Asian People, Humans
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 744 participants (actual)
- Lead sponsor
- KRL Hospital, IslamabadUniversity, hospital or other
- Collaborators
- Khyber Medical College, Peshawar, Quaid-e-Azam Medical College, Dow University of Health Sciences
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 29 Oct 2022 (actual)
- Study completion
- 26 Feb 2023 (actual)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sertraline | Experimental | Drug: SertralineSertraline |
| Escitalopram | Experimental | Drug: EscitalopramEscitalopram |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SertralineAlso: Sertraline pillSertraline (200 mg/day) capsule | Drug | Sertraline |
| EscitalopramAlso: Escitalopram pillEscitalopram (10 mg/day) capsule | Drug | Escitalopram |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan Mumtaz, MBBS, MRSPH study director
KRL Hospital, Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sertraline and Escitalopram in people with Major Depressive Disorder, run by KRL Hospital, Islamabad at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinical global impression (CGI) scale (time frame: 4 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.