drugset / Trial / NCT05978219

Efficacy of Mirtazapine in Major Depressive Disorder With Insomnia

NCT05978219

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-05-25
Primary completion
2023-12-31
Completion
2024-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Mirtazapine Other / unclassified 15 mg Oral
Subject Mirtazapine Other / unclassified 30 mg Oral
Subject Mirtazapine Other / unclassified 45 mg Oral