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NCT Number: NCT06530290

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

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.

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Key information

Conditions

Parkinson Disease Anxiety Anxiety Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish Hospital

Tehran, Iran

Location status: Recruiting

Location contact

Mehri Salari, MDFelloship

CONTACT

[email protected]

+989124972186

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mirtazapine 15 MG

Drug

Mirtazapine (15 mg), once a day for 12 weeks

Placebo

Drug

Placebo, once a day, for 12 weeks

Primary outcomes

  1. Anxiety score

    Time frame: Baseline, and after 4 and 12 weeks of treatment

    Anxiety score using Hamilton Anxiety Rating Scale (HAM-A)

  2. Anxiety score

    Time frame: Baseline, and after 4 and 12 weeks of treatment

    Parkinson Anxiety Scale (PAS) questionnaires

Secondary outcomes

  1. Depression score

    Time frame: Baseline, and after 4 and 12 weeks of treatment

    Depression score using Hamilton Depression Rating Scale (HAM-D) questionnaire

  2. Fatigue score

    Time frame: Baseline, and after 4 and 12 weeks of treatment

    Fatigue score using Parkinson's Disease Fatigue Scale (PDFS) questionnaire

  3. Sleep disorder score

    Time frame: Baseline, and after 4 and 12 weeks of treatment

    Sleep disorder score using Parkinson's disease Sleep Scale (PDSS) questionnaire

  4. Quality of life score

    Time frame: Baseline, and after 4 and 12 weeks of treatment

    Quality of life score using Parkinson's Disease Quality of Life (PDQL) questionnaire

Study contacts

Contact information is provided by the study sponsor or research team.

Leila Dargahi, PharmD/PhD

CONTACT

[email protected]

+989125069930

Sponsors and collaborators

Lead sponsor

Leila Dargahi. PharmD PhD

Other

Registry information

Official study title

Evaluating the Effect of Mirtazapine on Anxiety in Parkinson's Disease Patients; a Randomized Double-blinded Placebo-controlled Clinical Trial

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Jul 31, 2024
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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