Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mirtazapine | Experimental | Mirtazapine (15 mg), once a day, for 12 weeks |
|
| Placebo | Placebo Comparator | Placebo, once a day, for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mirtazapine 15 MG | Drug | Mirtazapine (15 mg), once a day for 12 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Depression score | Depression score using Hamilton Depression Rating Scale (HAM-D) questionnaire | Baseline, and after 4 and 12 weeks of treatment |
| Fatigue score | Fatigue score using Parkinson's Disease Fatigue Scale (PDFS) questionnaire |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leila Dargahi, PharmD/PhD | Contact | +989125069930 | l.dargahi@sbmu.ac.ir |
| Name | Affiliation | Role |
|---|---|---|
| Leila Dargahi, PharmD/PhD | Shahid Beheshti University of Medical Sciences | Principal Investigator |
| Mehri Salari, MDFellowship | Shahid Beheshti University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish Hospital | Recruiting | Tehran | Iran |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000078785 | Mirtazapine |
| ID | Term |
|---|---|
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Placebo, once a day, for 12 weeks |
|
| Baseline, and after 4 and 12 weeks of treatment |
| Sleep disorder score | Sleep disorder score using Parkinson's disease Sleep Scale (PDSS) questionnaire | Baseline, and after 4 and 12 weeks of treatment |
| Quality of life score | Quality of life score using Parkinson's Disease Quality of Life (PDQL) questionnaire | Baseline, and after 4 and 12 weeks of treatment |
| Neda Valian, PhD | Shahid Beheshti University of Medical Sciences | Study Director |
| Leila Mohaghegh Shalmani, PharmD/PhD | Shahid Beheshti University of Medical Sciences | Study Chair |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001523 | Mental Disorders |