drugset / Trial / NCT06530290

Evaluating the Effect of Mirtazapine on Anxiety in Parkinson's Disease Patients

NCT06530290

Phase 2 Recruiting 64 enrolled Shahid Beheshti University of Medical Sciences
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is a single-center, parallel and double-blind study in Movement Disorders Clinic of Shohadaye Tajrish Hospital. Patients, researchers (physicians, outcome assessors) and data analysts are blinded. After assessing the inclusion and exclusion criteria's, patients who assigned the informed consent form, are randomly divided into control and treatment groups.Patients in treatment or placebo groups respectively receive mirtazapine (15 mg) or placebo, once a day for 12 weeks. Primary (anxiety) and secondary (depression, fatigue, sleep disorders, and quality of life) outcomes are evaluated at baseline, and after 4 and 12 weeks of treatments.

Timeline

Start
2022-06-01
Primary completion
2025-12-20
Completion
2026-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Mirtazapine Other / unclassified 15 mg