Actively Recruiting
Evaluating the Effect of Mirtazapine on Anxiety in Parkinson's Disease Patients
Led by Leila Dargahi. PharmD PhD · Updated on 2025-05-21
64
Participants Needed
1
Research Sites
212 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.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.
CONDITIONS
Official Title
Evaluating the Effect of Mirtazapine on Anxiety in Parkinson's Disease Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women over 17 years old
- Patients with Parkinson's disease according to UKPDSBB criteria
- Patients with mild to moderate Parkinson's disease (Hoehn and Yahr Scale score 1-3)
- Self-reported or clinically diagnosed anxiety
- Signed informed consent to participate in the study
You will not qualify if you...
- Pregnant and lactating women
- Parkinson's patients with disease onset less than 1 year ago
- Unstable medication for Parkinson's disease in the last 2 weeks
- Parkinson's patients with deep brain stimulation (DBS)
- Patients with other neurodegenerative diseases like multiple system atrophy or Huntington's disease
- Patients with major depressive disorder
- Use of SSRIs, SNRIs, benzodiazepines, or beta-blockers in the last 4 weeks
- Use of MAO inhibitors
- History of alcohol or substance abuse
- History of acute stress in the last 3 months
- History of suicide
- History of cardiovascular diseases
- History of liver or kidney disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish Hospital
Tehran, Iran
Actively Recruiting
Research Team
L
Leila Dargahi, PharmD/PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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