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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease; Anxiety
• Intervention / Treatment: Drug: Mirtazapine 15 MG; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Leila Dargahi, PharmD/PhD; Phone Number: +989125069930; Email: l.dargahi@sbmu.ac.ir

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Recruiting
    • Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish Hospital
    • Contact: Mehri Salari, MDFelloship; Phone Number: +989124972186; Email: mehri.salari@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mirtazapine; Mirtazapine (15 mg), once a day, for 12 weeks	Drug: Mirtazapine 15 MG; Mirtazapine (15 mg), once a day for 12 weeks
Placebo Comparator: Placebo; Placebo, once a day, for 12 weeks	Drug: Placebo; Placebo, once a day, for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety score	Anxiety score using Hamilton Anxiety Rating Scale (HAM-A)	Baseline, and after 4 and 12 weeks of treatment
Anxiety score	Parkinson Anxiety Scale (PAS) questionnaires	Baseline, and after 4 and 12 weeks of treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Leila Dargahi. PharmD PhD
• Investigators: Principal Investigator: Leila Dargahi, PharmD/PhD, Shahid Beheshti University of Medical Sciences; Principal Investigator: Mehri Salari, MDFellowship, Shahid Beheshti University of Medical Sciences; Study Director: Neda Valian, PhD, Shahid Beheshti University of Medical Sciences; Study Chair: Leila Mohaghegh Shalmani, PharmD/PhD, Shahid Beheshti University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): December 20, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 22, 2024
• First Submitted That Met QC Criteria: July 27, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Actual): May 21, 2025
• Last Update Submitted That Met QC Criteria: May 18, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Anxiety; Parkinson's disease; Mirtazapine
• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Anxiety Disorders; Parkinson Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Histamine Antagonists; Histamine Agents; Neurotransmitter Agents; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Adrenergic Agents; Antidepressive Agents; Serotonin 5-HT3 Receptor Antagonists; Serotonin Antagonists; Serotonin Agents; Adrenergic Antagonists; Serotonin 5-HT2 Receptor Antagonists; Adrenergic alpha-Antagonists; Histamine H1 Antagonists; Adrenergic alpha-2 Receptor Antagonists; Mirtazapine
• Other Study ID Numbers: IR.SBMU.PHNS.REC.1400.130

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No