NCT05978219CompletedPhase 4
Efficacy of Mirtazapine in Major Depressive Disorder With Insomnia
Efficacy of Mirtazapine in Major Depressive Disorder With Insomnia: A 6-Week Pre and Post Intervention Study
Source: ClinicalTrials.gov · Last updated 2 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 135 (actual)
- First submitted
- 28 Jul 2023
- Start date
- 25 May 2023
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- National Institute of Mental Health, Dhaka
- Diseases
- Depression
- NCT number
- NCT05978219
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 135
- From 25 May 2023 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of use of mirtazapine in the last 3 months period.
- 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.
Other
- Pregnant or breastfeeding mother.
- At significant risk for suicide.
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Institute of Mental Health Coordinator of this site? Confirm its status | Dhaka | Bangladesh | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.