Image

Evaluating the Effect of Mirtazapine on Anxiety in Parkinson's Disease Patients

Evaluating the Effect of Mirtazapine on Anxiety in Parkinson's Disease Patients

Recruiting
18 years and older
All
Phase 2

Powered by AI

Overview

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

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

Study details
    Parkinson Disease
    Anxiety

NCT06530290

Leila Dargahi. PharmD PhD

25 May 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.