Parkinson’s disease. Parkinson's disease
Conditions
Interventions
Intervention 1: Intervention group: Mirtazapine (15mg), once a day, for 12 weeks. Intervention 2: Control group: Placebo, once a day, for 12 weeks.
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
17 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMehri Salari
Shahid Beheshti University of Medical Sciences
Outcome results
None listed