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

NCT06530290 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-05-21

No results posted yet for this study

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

Interventions

DRUG

Mirtazapine 15 MG

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

DRUG

Placebo

Placebo, once a day, for 12 weeks

Sponsors & Collaborators

  • Leila Dargahi. PharmD PhD

    lead OTHER

Principal Investigators

  • Leila Dargahi, PharmD/PhD · Shahid Beheshti University of Medical Sciences

  • Mehri Salari, MDFellowship · Shahid Beheshti University of Medical Sciences

  • Neda Valian, PhD · Shahid Beheshti University of Medical Sciences

  • Leila Mohaghegh Shalmani, PharmD/PhD · Shahid Beheshti University of Medical Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2025-12-20
Completion
2026-06-30

Countries

  • Iran

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06530290 on ClinicalTrials.gov