Evaluating the effect of mirtazapine on anxiety in Parkinson's patients
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion 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: 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 and or kidney disorders.
Intervention groups
Control (placebo) and mirtazapine groups
Main outcome variables
Anxiety score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191022045196N2
Registration date:2022-06-09, 1401/03/19
Registration timing:registered_while_recruiting
Last update:2022-06-09, 1401/03/19
Update count:0
Registration date
2022-06-09, 1401/03/19
Registrant information
Name
Neda Valian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2242 9768
Email address
n.valian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-06, 1401/03/16
Expected recruitment end date
2024-06-05, 1403/03/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of mirtazapine on anxiety in Parkinson’s disease patients; a randomized double-blinded placebo-controlled clinical trial
Public title
Evaluating the effect of mirtazapine on anxiety in Parkinson’s disease patients
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 17 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
Blinding description
Patients, researchers (physicians, outcome assessors) and data analysts are not aware about prescribed drugs.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of School of Public Health and Neuroscience Research Center, Shahid Beheshti Univer
Street address
School of Public Health and Neuroscience Research Center, Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Yaman Ave., Shahid Chamran Exp., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2022-01-04, 1400/10/14
Ethics committee reference number
IR.SBMU.PHNS.REC.1400.130
Health conditions studied
1
Description of health condition studied
Parkinson’s disease
ICD-10 code
G20
ICD-10 code description
Parkinson's disease
Primary outcomes
1
Description
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 outcomes
1
Description
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
2
Description
Fatigue score
Timepoint
Fatigue score at the baseline, and after 4 and 12 weeks of treatment