NCT06530290 Evaluating the Effect of Mirtazapine on Anxiety in Parkinson's Disease Patients
| NCT ID | NCT06530290 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Leila Dargahi. PharmD PhD |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2022-06-01 |
| Primary Completion | 2025-12-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 64 participants in total. It began in 2022-06-01 with a primary completion date of 2025-12-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Leila Dargahi, PharmD/PhD
PRINCIPAL INVESTIGATOR
Shahid Beheshti University of Medical Sciences
Frequently Asked Questions
Who can join the NCT06530290 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06530290 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06530290 currently recruiting?
Yes, NCT06530290 is actively recruiting participants. Contact the research team at l.dargahi@sbmu.ac.ir for enrollment information.
Where is the NCT06530290 trial being conducted?
This trial is being conducted at Tehran, Iran.
Who is sponsoring the NCT06530290 clinical trial?
NCT06530290 is sponsored by Leila Dargahi. PharmD PhD. The principal investigator is Leila Dargahi, PharmD/PhD at Shahid Beheshti University of Medical Sciences. The trial plans to enroll 64 participants.
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