Evaluating the effect of mirtazapine on anxiety in Parkinson’s disease patients

Phase 2

Recruiting

• Conditions: Parkinson’s disease.; Parkinson's disease

• Registration Number: IRCT20191022045196N2
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Men and women over 17 years old
Patient with Parkinson's disease according to UKPDSBB criteria
Patient with mild/moderate Parkinson’s disease according to Hoehn and Yahr Scale (HY score = 1-3)
Self-report or clinical diagnosis of anxiety
Patients who have signed informed consent to participate in the study

Exclusion Criteria

Pregnant and lactating women
Parkinson's patients with onset of disease in less than 1 year
Unstable medication for Parkinson's disease during the last two weeks
Parkinson's patients with DBS
Patients with other neurodegenerative diseases like multiple system atrophy (MSA), Huntington's and etc.
Patients with major depressive disorder
A history of using SSRIs, SNRIs, benzodiazepines and ß-blockers during the last 4 weeks
A history of using MAO inhibitors
A history of alcohol and substance abuse
A history of acute stress during the last 3 months
A history of suicide
A history of cardiovascular diseases
A history of liver disorders
A history of kidney disorders

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Anxiety score. Timepoint: Anxiety score at the baseline, and after 4 and 12 weeks of treatment. Method of measurement: Hamilton Anxiety Rating Scale (HAM-A) and Parkinson Anxiety Scale (PAS) questionnaires.

Secondary Outcome Measures

Name	Time	Method
Depression score. Timepoint: Depression score at the baseline, and after 4 and 12 weeks of treatment. Method of measurement: Hamilton Depression Rating Scale (HAM-D) questionnaire.;Fatigue score. Timepoint: Fatigue score at the baseline, and after 4 and 12 weeks of treatment. Method of measurement: Parkinson’s Disease Fatigue Scale (PDFS) questionnaire.;Sleep disorder score. Timepoint: Sleep disorder score at the baseline, and after 4 and 12 weeks of treatment. Method of measurement: Parkinson's disease Sleep Scale (PDSS) questionnaire.;Quality of life score. Timepoint: Quality of life score at the baseline, and after 4 and 12 weeks of treatment. Method of measurement: Parkinson's Disease Quality of Life (PDQL) questionnaire.