Ignite Creation Date:
2024-05-06 @ 7:19 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05978219
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2023-07-28
Brief Title:
Efficacy of Mirtazapine in Major Depressive Disorder With Insomnia
Sponsor:
National Institute of Mental Health Dhaka
Organization:
National Institute of Mental Health Dhaka
Study Overview
Official Title:
Efficacy of Mirtazapine in Major Depressive Disorder With Insomnia A 6-Week Pre and Post Intervention Study
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This will be a single center prospective open label quasi-experimental pre-post intervention trial in major depressive disorder MDD patients with insomnia
The main objectives are i to assess efficacy of mirtazapine in reducing depression and insomnia symptom severity in major depressive disorder MDD patients with insomnia
ii to evaluate side effects of mirtazapine
Following enrollment and baseline assessment patients will be prescribed mirtazapine at 15-30 mgday Depending on the response doses will be adjusted after two weeks and might be titrated up to 45 mgday
Each patient will be monitored for 42 days and assessment will be carried out on Day 0 Day 14 Day 28 and Day 42 of the trial
The main objectives are i to assess efficacy of mirtazapine in reducing depression and insomnia symptom severity in major depressive disorder MDD patients with insomnia
ii to evaluate side effects of mirtazapine
Following enrollment and baseline assessment patients will be prescribed mirtazapine at 15-30 mgday Depending on the response doses will be adjusted after two weeks and might be titrated up to 45 mgday
Each patient will be monitored for 42 days and assessment will be carried out on Day 0 Day 14 Day 28 and Day 42 of the trial
Detailed Description:
Background Mirtazapine is an atypical antidepressant acts by increasing noradrenergic and serotonergic neurotransmission It inhibits presynaptic adrenergic alpha-2 receptor along with inhibition of postsynaptic serotonergic 5-HT2 and 5-HT3 receptors and histamine H1 receptor Jilani et al 2022 It was approved by FDA in 1996 for treating moderate and severe depression but it also has sedative antiemetic anxiolytic and appetite stimulant effects and for these prescribed in many other psychiatric disorders Nutt 2002 Because of its efficacy safety and tolerability it is one of the drugs recommended by NICE to consider as first-choice in treating depression Middleton et al 2005
A depressive episode is characterized by a period of depressed mood or diminished interest in activities occurring most of the day nearly every day during a period lasting at least two weeks accompanied by other symptoms such as difficulty concentrating feelings of worthlessness or excessive or inappropriate guilt hopelessness recurrent thoughts of death or suicide changes in appetite or sleep psychomotor agitation or retardation and reduced energy or fatigue There have never been any prior manic hypomanic or mixed episodes which would indicate the presence of a bipolar disorder ICD-11 2019
Around 67 of adult population in Bangladesh suffers from depressive disorders NIMH 2019 However no interventional study has yet been carried out to see efficacy of different antidepressants in this population As one of the frequently observed features of depression is insomnia mirtazapine could be a good choice in these cases This study intends to assess the efficacy of mirtazapine in major depressive disorder when the patients also present with insomnia
General objective To assess the efficacy of mirtazapine in reducing depression with insomnia symptoms in patients with major depressive disorder MDD with insomnia
Specific objectives
1 To assess the efficacy of mirtazapine in reducing depressive symptoms in patients with MDD with insomnia
2 To assess the efficacy of mirtazapine in reducing insomnia symptoms in patients with MDD with insomnia
3 To compare the quality of life in patients with MDD before and after introducing mirtazapine
4 To assess the side-effects experienced by trial patients
Methods This will be a single center prospective open label quasi-experimental pre-post intervention trial in MDD patients with insomnia The study will be conducted at National Institute of Mental Health NIMH Bangladesh over a period of 8 months A total of 135 MDD patients with insomnia who fulfill the selection criteria will be conveniently selected for the study Following enrollment and baseline assessment patients will be prescribed mirtazapine at 15-30 mgday Depending on the response doses will be adjusted after two weeks and might be titrated up to 45 mgday
Each patient will be monitored for 42 days and assessment will be carried out on Day 0 Day 14 Day 28 and Day 42 of the trial A semi-structured clinical information questionnaire Hamilton Depression Rating Scale HDRS Insomnia Severity Index ISI Antidepressant Side-Effect Checklist ASEC World Health Organization Quality of Life WHOQOL-BREF will be used by research psychiatrists during assessment
The whole study will be on accordance with Helsinki Declaration and prior to commencement ethical approval will be taken from IRB and Bangladesh Medical Research Council BMRC The protocol will also be registered with the International Clinical Trials Registry Platform ICTRP
Potential significance The findings will generate information on efficacy of mirtazapine in reducing depressive and insomnia symptom severity in MDD patients with insomnia and regarding side effects of mirtazapine in Bangladeshi adult population
Funding This study is conceptualized and sponsored by Bangladesh Association of Psychiatrists BAP with scientific support and research grant from Sun Pharmaceutical Bangladesh Ltd
A depressive episode is characterized by a period of depressed mood or diminished interest in activities occurring most of the day nearly every day during a period lasting at least two weeks accompanied by other symptoms such as difficulty concentrating feelings of worthlessness or excessive or inappropriate guilt hopelessness recurrent thoughts of death or suicide changes in appetite or sleep psychomotor agitation or retardation and reduced energy or fatigue There have never been any prior manic hypomanic or mixed episodes which would indicate the presence of a bipolar disorder ICD-11 2019
Around 67 of adult population in Bangladesh suffers from depressive disorders NIMH 2019 However no interventional study has yet been carried out to see efficacy of different antidepressants in this population As one of the frequently observed features of depression is insomnia mirtazapine could be a good choice in these cases This study intends to assess the efficacy of mirtazapine in major depressive disorder when the patients also present with insomnia
General objective To assess the efficacy of mirtazapine in reducing depression with insomnia symptoms in patients with major depressive disorder MDD with insomnia
Specific objectives
1 To assess the efficacy of mirtazapine in reducing depressive symptoms in patients with MDD with insomnia
2 To assess the efficacy of mirtazapine in reducing insomnia symptoms in patients with MDD with insomnia
3 To compare the quality of life in patients with MDD before and after introducing mirtazapine
4 To assess the side-effects experienced by trial patients
Methods This will be a single center prospective open label quasi-experimental pre-post intervention trial in MDD patients with insomnia The study will be conducted at National Institute of Mental Health NIMH Bangladesh over a period of 8 months A total of 135 MDD patients with insomnia who fulfill the selection criteria will be conveniently selected for the study Following enrollment and baseline assessment patients will be prescribed mirtazapine at 15-30 mgday Depending on the response doses will be adjusted after two weeks and might be titrated up to 45 mgday
Each patient will be monitored for 42 days and assessment will be carried out on Day 0 Day 14 Day 28 and Day 42 of the trial A semi-structured clinical information questionnaire Hamilton Depression Rating Scale HDRS Insomnia Severity Index ISI Antidepressant Side-Effect Checklist ASEC World Health Organization Quality of Life WHOQOL-BREF will be used by research psychiatrists during assessment
The whole study will be on accordance with Helsinki Declaration and prior to commencement ethical approval will be taken from IRB and Bangladesh Medical Research Council BMRC The protocol will also be registered with the International Clinical Trials Registry Platform ICTRP
Potential significance The findings will generate information on efficacy of mirtazapine in reducing depressive and insomnia symptom severity in MDD patients with insomnia and regarding side effects of mirtazapine in Bangladeshi adult population
Funding This study is conceptualized and sponsored by Bangladesh Association of Psychiatrists BAP with scientific support and research grant from Sun Pharmaceutical Bangladesh Ltd
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None