Major Depressive Disorder With InsomniaPhase 4NCT05978219
Efficacy of Mirtazapine in Major Depressive Disorder With Insomnia
A Phase 4 study testing Mirtazapine Tablets in people with Major Depressive Disorder With Insomnia, run by National Institute of Mental Health, Dhaka at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder With Insomnia
- What is being tested?
- Mirtazapine Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteBangladesh
- Study dates
- 25 May 2023to 1 Mar 2024
- Phase
- Phase 4
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-60 years.
- Diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) for MDD.
- A ≥20 total score on the 17-item Hamilton depression rating scale (HDRS).
- A ≥15 total score on the 7-item Insomnia Severity Index (ISI).
- Considered to require antidepressant treatment based on the judgment of the consulting psychiatrist.
- For women - willing to abstain from conception or willing to use modern method of contraception (she or her partner) during trial period.
Who cannot join
- History of use of mirtazapine in the last 3 months period.
- Pregnant or breastfeeding mother.
- At significant risk for suicide.
- Diagnosed with a primary condition including dementia as well as bipolar, obsessive-compulsive, or eating disorders, schizophrenia, or alcohol or substance dependence except for tobacco dependence.
- Experiencing any medical conditions judged to render the patient ineligible to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Mirtazapine in Major Depressive Disorder With Insomnia: A 6-Week Pre and Post Intervention Study
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.
Read more
ii. to evaluate side effects of mirtazapine.
Following enrollment and baseline assessment patients will be prescribed mirtazapine at 15-30 mg/day. Depending on the response, doses will be adjusted after two weeks and might be titrated up to 45 mg/day.
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.
Read the 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 6.7% 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
- To assess the efficacy of mirtazapine in reducing depressive symptoms in patients with MDD with insomnia.
- To assess the efficacy of mirtazapine in reducing insomnia symptoms in patients with MDD with insomnia.
- To compare the quality of life in patients with MDD before and after introducing mirtazapine.
- 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 mg/day. Depending on the response, doses will be adjusted after two weeks and might be titrated up to 45 mg/day.
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.
- Conditions
- Major Depressive Disorder With Insomnia
- Being tested
- Mirtazapine Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirtazapine TabletsDrug
Mirtazapine tablet form, orally, once or twice daily, 15-45 mg
| Study group | Role | What they receive |
|---|---|---|
| Patients with MDD with insomnia | Experimental | Diagnosed MDD patients with insomnia problems will be approached and enrolled from NIMH, Dhaka.
Trial medications will be self-administered and treatment regimen will be continued until serious adverse effect develops or for 42 days, whichever occurs sooner.
Patients will receive mirtazapine at 15-30 mg/day (tablet form, once or twice daily, orally) from start. Depending on the response, doses might be increased at 2 weeks up to 45 mg/day for mirtazapine.
The clinical trial for each patient will last for 42 days. Clinical data will be collected at the beginning - Day 0 and then on Day 14 and Day 42 of the trial by face-to-face interview. A clinical follow up will be provided to trial patients on Day 28 of the trial over telephone. Research psychiatrists will also conduct follow up, medication and side effect monitoring and overall management of the patients. Receives: Drug: Mirtazapine Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean Hamilton Depression Rating Scale score
Hamilton Depression Rating Scale is one of the most widely used clinician-administered depression assessment scale. The 17-item version score ranges between 0-53 with higher score indicates worse outcome.
Measured: At Day 0, Day 14 and Day 42
Change from baseline in mean Insomnia Severity Index score
The Insomnia Severity Scale is a 7-item and 5-point Likert self-report questionnaire which is used to assess the nature, severity, and impact of insomnia. The total score can be between 0-35 and higher score indicates worse outcome.
Measured: At Day 0, Day 14 and Day 42
Secondary outcomes (2)
Frequency and severity of side effects experienced by trial patients as measured by Antidepressant Side-Effect Checklist
This is a self-reporting side-effect checklist developed by Royal College of the Psychiatrist for those taking antidepressants. There are 21 items each mentioning a particular side effect and for each item, the participants rated the severity of the specified symptom on a four-point scale (0 absent; 1 mild; 2 moderate; 3 severe) and specified whether a symptom (if present) was likely to be a side-effect of the antidepressant drug (yes or no).
Measured: Day 14 and Day 42
Change from baseline in mean World Health Organization Quality of Life score
The WHOQOL-BREF is a 26-item questionnaire in a Likert scale format that assesses individuals' perceptions of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns. The 26 items can be answered in a 1-5 Likert scale format; The scale is scored by adding up the score on each item to yield a total score for the instrument. It assesses quality of life in four domains namely physical, psychological, social and environmental. The converted scores for each domain range between 0-100 and a higher score indicates higher quality of life in that domain.
Measured: Day 0 and Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start25 May 2023
- Primary completion31 Dec 2023
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive Disorder With InsomniaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Quasi-experimental pre-post intervention trial
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health, Dhaka
- Sponsor type
- University, hospital or other
- Collaborators
- Sun Pharmaceutical Industries Limited
- Responsible party
- Principal investigator, Dr. Ahsan Aziz Sarkar, National Institute of Mental Health, Dhaka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978219
- Sponsor's protocol ID
- 2023/12
- Status last verified
- Apr 2024
- First submitted
- 28 Jul 2023
- Last updated
- 2 Apr 2024
- 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 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Mirtazapine in Major Depressive Disorder With Insomnia: A 6-Week Pre and Post Intervention Study
- ClinicalTrials.gov ID
- NCT05978219
- Acronym / sponsor ID
- 2023/12
- Conditions
- Major Depressive Disorder With Insomnia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- National Institute of Mental Health, DhakaUniversity, hospital or other
- Collaborators
- Sun Pharmaceutical Industries Limited
- Study start
- 25 May 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 7 Aug 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.
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 mg/day. Depending on the response, doses will be adjusted after two weeks and might be titrated up to 45 mg/day.
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 6.7% 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
- To assess the efficacy of mirtazapine in reducing depressive symptoms in patients with MDD with insomnia.
- To assess the efficacy of mirtazapine in reducing insomnia symptoms in patients with MDD with insomnia.
- To compare the quality of life in patients with MDD before and after introducing mirtazapine.
- 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 mg/day. Depending on the response, doses will be adjusted after two weeks and might be titrated up to 45 mg/day.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quasi-experimental pre-post intervention trial
| Arm | Type | Receives |
|---|---|---|
| Patients with MDD with insomnia | Experimental | Drug: Mirtazapine TabletsDiagnosed MDD patients with insomnia problems will be approached and enrolled from NIMH, Dhaka. Trial medications will be self-administered and treatment regimen will be continued until serious adverse effect develops or for 42 days, whichever occurs sooner. Patients will receive mirtazapine at 15-30 mg/day (tablet form, once or twice daily, orally) from start. Depending on the response, doses might be increased at 2 weeks up to 45 mg/day for mirtazapine. The clinical trial for each patient will last for 42 days. Clinical data will be collected at the beginning - Day 0 and then on Day 14 and Day 42 of the trial by face-to-face interview. A clinical follow up will be provided to trial patients on Day 28 of the trial over telephone. Research psychiatrists will also conduct follow up, medication and side effect monitoring and overall management of the patients. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-60 years.
- Diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) for MDD.
- A ≥20 total score on the 17-item Hamilton depression rating scale (HDRS).
- A ≥15 total score on the 7-item Insomnia Severity Index (ISI).
- Considered to require antidepressant treatment based on the judgment of the consulting psychiatrist.
Key exclusion criteria (5 listed)
- History of use of mirtazapine in the last 3 months period.
- Pregnant or breastfeeding mother.
- At significant risk for suicide.
- Diagnosed with a primary condition including dementia as well as bipolar, obsessive-compulsive, or eating disorders, schizophrenia, or alcohol or substance dependence except for tobacco dependence.
- Experiencing any medical conditions judged to render the patient ineligible to participate in the study.
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 |
|---|---|---|
| Mirtazapine TabletsMirtazapine tablet form, orally, once or twice daily, 15-45 mg | Drug | Patients with MDD with insomnia |
Primary outcome
Change from baseline in mean Hamilton Depression Rating Scale score
Time frame: At Day 0, Day 14 and Day 42
Hamilton Depression Rating Scale is one of the most widely used clinician-administered depression assessment scale. The 17-item version score ranges between 0-53 with higher score indicates worse outcome.
Change from baseline in mean Insomnia Severity Index score
Time frame: At Day 0, Day 14 and Day 42
The Insomnia Severity Scale is a 7-item and 5-point Likert self-report questionnaire which is used to assess the nature, severity, and impact of insomnia. The total score can be between 0-35 and higher score indicates worse outcome.
2 secondary outcomes
Frequency and severity of side effects experienced by trial patients as measured by Antidepressant Side-Effect Checklist
Time frame: Day 14 and Day 42
Change from baseline in mean World Health Organization Quality of Life score
Time frame: Day 0 and Day 42
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 2 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mirtazapine Tablets in people with Major Depressive Disorder With Insomnia, run by National Institute of Mental Health, Dhaka at 1 site in Bangladesh.
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 6 inclusion and 5 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 2 Apr 2024. 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 Bangladesh. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 from baseline in mean Hamilton Depression Rating Scale score (time frame: At Day 0, Day 14 and Day 42). The study lists 2 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 2 Apr 2024.