Status:
RECRUITING
Evaluating the Effect of Mirtazapine on Anxiety in Parkinson's Disease Patients
Lead Sponsor:
Leila Dargahi. PharmD PhD
Conditions:
Parkinson Disease
Anxiety
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06530290
Start Date
June 1 2022
End Date
June 30 2026
Last Update
May 21 2025
Active Locations (1)
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1
Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish Hospital
Tehran, Iran