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

Phase 2

Recruiting

• Conditions: Parkinson Disease; Anxiety
• Interventions: Drug: Mirtazapine 15 MG; Drug: Placebo

• Registration Number: NCT06530290
• Lead Sponsor: Leila Dargahi. PharmD PhD

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-01
• Study First Submitted: 2024-04-22
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-27
• Study First Posted: 2024-07-31
• Last Update Submitted: 2025-05-18
• Last Update Posted: 2025-05-21
• Primary Completion: 2025-12-20
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mirtazapine	Mirtazapine 15 MG	Mirtazapine (15 mg), once a day, for 12 weeks
Placebo	Placebo	Placebo, once a day, for 12 weeks

Primary Outcome Measures

Name	Time	Method
Anxiety score	Baseline, and after 4 and 12 weeks of treatment	Parkinson Anxiety Scale (PAS) questionnaires

Secondary Outcome Measures

Name	Time	Method
Depression score	Baseline, and after 4 and 12 weeks of treatment	Depression score using Hamilton Depression Rating Scale (HAM-D) questionnaire
Fatigue score	Baseline, and after 4 and 12 weeks of treatment	Fatigue score using Parkinson's Disease Fatigue Scale (PDFS) questionnaire
Sleep disorder score	Baseline, and after 4 and 12 weeks of treatment	Sleep disorder score using Parkinson's disease Sleep Scale (PDSS) questionnaire
Quality of life score	Baseline, and after 4 and 12 weeks of treatment	Quality of life score using Parkinson's Disease Quality of Life (PDQL) questionnaire

Trial Locations

Locations (1)

Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of