RecruitingPhase 2NCT06530290

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

Sponsor

Leila Dargahi. PharmD PhD

Enrollment

64 participants

Start Date

Jun 1, 2022

Study Type

INTERVENTIONAL

Conditions

Anxiety Parkinson Disease

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 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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a drug called mirtazapine (an antidepressant) can help reduce anxiety in people with Parkinson's disease. Anxiety is a common but often undertreated symptom in Parkinson's, and this trial explores whether this medication can improve quality of life. **You may be eligible if...** - You are 17 years or older - You have been diagnosed with Parkinson's disease - Your Parkinson's is mild to moderate (Hoehn and Yahr stage 1–3) - You report experiencing anxiety - You have been on a stable Parkinson's medication regimen **You may NOT be eligible if...** - You are pregnant or breastfeeding - Your Parkinson's disease started less than 1 year ago - Your Parkinson's medications have changed recently - You have severe dementia or other psychiatric conditions that could affect the results Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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