Evaluating Mirtazapine's effect on anxiety in Parkinson's patients
Evaluating the Effect of Mirtazapine on Anxiety in Parkinson's Disease Patients; a Randomized Double-blinded Placebo-controlled Clinical Trial
This study is testing whether the medication mirtazapine can help reduce anxiety in people with Parkinson's disease.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shahid Beheshti University of Medical Sciences Academic / other |
| Locations | 1 site (Tehran) |
| Trial ID | NCT06530290 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of mirtazapine on anxiety levels in patients diagnosed with Parkinson's disease. Conducted at the Movement Disorders Clinic of Shohadaye Tajrish Hospital, the study employs a double-blind, placebo-controlled design where participants are randomly assigned to receive either mirtazapine or a placebo for 12 weeks. The primary outcome focuses on anxiety, while secondary outcomes include depression, fatigue, sleep disorders, and quality of life, assessed at baseline, 4 weeks, and 12 weeks. The study aims to provide insights into the efficacy of mirtazapine for managing anxiety in this patient population.
Who should consider this trial
Good fit: Ideal candidates include men and women over 17 years old with mild to moderate Parkinson's disease and a self-reported or clinically diagnosed anxiety.
Not a fit: Patients with major depressive disorder, other neurodegenerative diseases, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for managing anxiety in patients with Parkinson's disease.
How similar studies have performed: While there is limited data on mirtazapine specifically for anxiety in Parkinson's patients, similar studies have explored antidepressants for anxiety management in neurological conditions, indicating potential for success.
Eligibility criteria
Show full 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 and or kidney disorders
Where this trial is running
Tehran
- Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish Hospital — Tehran, Iran (Recruiting)
Study contacts
- Principal investigator: Leila Dargahi, PharmD/PhD — Shahid Beheshti University of Medical Sciences
- Study coordinator: Leila Dargahi, PharmD/PhD
- Email: l.dargahi@sbmu.ac.ir
- Phone: +989125069930
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.