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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Islamic Republic of Iran
Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish Hospital
RECRUITING
Tehran
Contact Information
Primary
Leila Dargahi, PharmD/PhD
l.dargahi@sbmu.ac.ir
+989125069930
Time Frame
Start Date: 2022-06-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 64
Treatments
Experimental: Mirtazapine
Mirtazapine (15 mg), once a day, for 12 weeks
Placebo_comparator: Placebo
Placebo, once a day, for 12 weeks
Related Therapeutic Areas
Sponsors
Leads: Leila Dargahi. PharmD PhD

This content was sourced from clinicaltrials.gov

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