Clinical trial NCT06530290: Evaluating the Effect of Mirtazapine on Anxiety in Parkinson's Disease Patients
Official title: Evaluating the Effect of Mirtazapine on Anxiety in Parkinson's Disease Patients; a Randomized Double-blinded Placebo-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Parkinson Disease
Anxiety
Keywords: Parkinson's disease
Anxiety
Mirtazapine
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Anxiety score
timeFrame: Baseline, and after 4 and 12 weeks of treatment
measure: Anxiety score
timeFrame: Baseline, and after 4 and 12 weeks of treatment
Secondary outcomes:
measure: Depression score
timeFrame: Baseline, and after 4 and 12 weeks of treatment
measure: Fatigue score
timeFrame: Baseline, and after 4 and 12 weeks of treatment
measure: Sleep disorder score
timeFrame: Baseline, and after 4 and 12 weeks of treatment
measure: Quality of life score
timeFrame: Baseline, and after 4 and 12 weeks of treatment
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish Hospital
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Leila Dargahi, PharmD/PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shahid Beheshti University of Medical Sciences
name: Mehri Salari, MDFellowship
role: PRINCIPAL_INVESTIGATOR
affiliation: Shahid Beheshti University of Medical Sciences
name: Neda Valian, PhD
role: STUDY_DIRECTOR
affiliation: Shahid Beheshti University of Medical Sciences
name: Leila Mohaghegh Shalmani, PharmD/PhD
role: STUDY_CHAIR
References: