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

NCT06530290 | Recruiting Phase 2 DMC

• 1 other identifier: IR.SBMU.PHNS.REC.1400.130
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Anxiety

Keywords

Parkinson's disease; Anxiety; Mirtazapine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Depression score

  Baseline, and after 4 and 12 weeks of treatment

• Fatigue score

  Baseline, and after 4 and 12 weeks of treatment

• Sleep disorder score

  Baseline, and after 4 and 12 weeks of treatment

• Quality of life score

  Baseline, and after 4 and 12 weeks of treatment

Study Arms (2)

Mirtazapine

EXPERIMENTAL

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

Drug: Mirtazapine 15 MG

Placebo

PLACEBO COMPARATOR

Placebo, once a day, for 12 weeks

Drug: Placebo

Interventions

Mirtazapine 15 MG DRUG

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

Mirtazapine

Placebo DRUG

Placebo, once a day, for 12 weeks

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Leila Dargahi. PharmD PhD: lead

Study Sites (1)

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

Tehran, Iran

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Anxiety Disorders

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Leila Dargahi, PharmD/PhD

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Mehri Salari, MDFellowship

  Shahid Beheshti University of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Neda Valian, PhD

  Shahid Beheshti University of Medical Sciences

  STUDY DIRECTOR

• Leila Mohaghegh Shalmani, PharmD/PhD

  Shahid Beheshti University of Medical Sciences

  STUDY CHAIR

Central Study Contacts

Leila Dargahi, PharmD/PhD

CONTACT

+989125069930; l.dargahi@sbmu.ac.ir

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: July 31, 2024
• Study Start: June 1, 2022
• Primary Completion: December 20, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: May 21, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)