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RECRUITING
NCT06530290
PHASE2

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

Sponsor: Leila Dargahi. PharmD PhD

View on ClinicalTrials.gov

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.

Official title: Evaluating the Effect of Mirtazapine on Anxiety in Parkinson's Disease Patients; a Randomized Double-blinded Placebo-controlled Clinical Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2022-06-01

Completion Date

2026-06-30

Last Updated

2025-05-21

Healthy Volunteers

No

Interventions

DRUG

Mirtazapine 15 MG

Mirtazapine (15 mg), once a day for 12 weeks

DRUG

Placebo

Placebo, once a day, for 12 weeks

Locations (1)

Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish Hospital

Tehran, Iran