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IRCT20191022045196N2 IRCT 2022-06-09 Shahid Beheshti University of Medical Sciences Evaluating the effect of mirtazapine on anxiety in Parkinson’s disease patients Evaluating the effect of mirtazapine on anxiety in Parkinson’s disease patients; a randomized double-blinded placebo-controlled clinical trial 2022-06-06 anticipated 64 Complete https://irct.ir/trial/61832 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization method is used to divide the patients into placebo or drug groups. The patients will be assigned to placebo or drug groups (A and B) based on a random list prepared using SPSS software. For concealment, the placebo and drug are labeled as A and B, so patients and the researcher are unaware about the type of drug in each package, Blinding description: Patients, researchers (physicians, outcome assessors) and data analysts are not aware about prescribed drugs. 2 Parkinson’s disease. Intervention 1: Intervention group: Mirtazapine (15mg), once a day, for 12 weeks. Intervention 2: Control group: Placebo, once a day, for 12 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Undecided - It is not yet known if there will be a plan to make this available
public Mehri Salari
Shohadaye Tajrish Hospital, Tajrish Square, Tehran
Tehran Iran (Islamic Republic of) 1989934148 +98 21 25719 mehri.salari@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Leila dargahi
Neuroscience Research Center, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Yaman Ave., Shahid Chamran Exp., Tehran
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2242 9768 l.dargahi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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 17 years no limit Both 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 β-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 G20 Parkinson's disease Treatment - Drugs Placebo Intervention group: Mirtazapine (15mg), once a day, for 12 weeks Control group: Placebo, once a day, for 12 weeks 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. 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. Shahid Beheshti University of Medical Sciences Approved 2022-01-04 Ethics committee of School of Public Health and Neuroscience Research Center, Shahid Beheshti Univer School of Public Health and Neuroscience Research Center, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Yaman Ave., Shahid Chamran Exp., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)