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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
Mirtazapine (15 mg), once a day for 12 weeks
Placebo, once a day, for 12 weeks
Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish Hospital
Tehran, Iran
RECRUITINGAnxiety score
Anxiety score using Hamilton Anxiety Rating Scale (HAM-A)
Time frame: Baseline, and after 4 and 12 weeks of treatment
Anxiety score
Parkinson Anxiety Scale (PAS) questionnaires
Time frame: Baseline, and after 4 and 12 weeks of treatment
Depression score
Depression score using Hamilton Depression Rating Scale (HAM-D) questionnaire
Time frame: Baseline, and after 4 and 12 weeks of treatment
Fatigue score
Fatigue score using Parkinson's Disease Fatigue Scale (PDFS) questionnaire
Time frame: Baseline, and after 4 and 12 weeks of treatment
Sleep disorder score
Sleep disorder score using Parkinson's disease Sleep Scale (PDSS) questionnaire
Time frame: Baseline, and after 4 and 12 weeks of treatment
Quality of life score
Quality of life score using Parkinson's Disease Quality of Life (PDQL) questionnaire
Time frame: Baseline, and after 4 and 12 weeks of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.