Efficacy of Mirtazapine in Major Depressive Disorder With Insomnia (NCT05978219) | Clinical Trial Compass
CompletedPhase 4
Efficacy of Mirtazapine in Major Depressive Disorder With Insomnia
Bangladesh135 participantsStarted 2023-05-25
Plain-language 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 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
What they're measuring
1
Change from baseline in mean Hamilton Depression Rating Scale score
Timeframe: At Day 0, Day 14 and Day 42
2
Change from baseline in mean Insomnia Severity Index score