Reduce anxiety symptoms with mirtazapine
- Trial ID
- NCT06530290
- Official Title
- Evaluating the Effect of Mirtazapine on Anxiety in Parkinson's Disease Patients; a Randomized Double-blinded Placebo-controlled Clinical Trial
- Goal
- Reduce anxiety symptoms with mirtazapine
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- Leila Dargahi. PharmD PhD
- Study Type
- INTERVENTIONAL
- Enrollment
- 64 participants
- Conditions
- Parkinson Disease, Anxiety
- Interventions
- Mirtazapine 15 MG, Placebo
Plain-Language Summary
They're testing whether mirtazapine can reduce anxiety in people with Parkinson's, a common symptom that can seriously affect daily life. Mirtazapine is an antidepressant that boosts serotonin and norepinephrine signaling by blocking alpha-2 receptors and certain serotonin receptors, which can ease anxiety and often helps sleep and appetite; it is being compared to placebo. It does not replace levodopa, and while it has no major direct interaction with levodopa, it can cause sedation or low blood pressure so the trial asks for stable Parkinson's medications. The study is enrolling adults 18 and older with mild to moderate Parkinson's (Hoehn and Yahr 1,3) who have anxiety, excluding people with deep brain stimulation, recent antidepressant or MAOI use, major depression, unstable PD meds, serious heart/liver/kidney disease, pregnancy, or recent substance abuse.
Locations
- Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish Hospital, Tehran, Iran
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Mirtazapine 15 MG. They're testing whether mirtazapine can reduce anxiety in people with Parkinson's, a common symptom that can seriously affect daily life. Mirtazapine is an antidepressant that boosts serotonin and norepinephrine signaling by blocking alpha-2 receptors and certain serotonin receptors, which can ease anxiety and often helps sleep and appetite; it is being compared to placebo. It does not replace levodopa, and while it has no major direct interaction with levodopa, it can cause sedation or low blood pressure so the trial asks for stable Parkinson's medications. The study is enrolling adults 18 and older with mild to moderate Parkinson's (Hoehn and Yahr 1,3) who have anxiety, excluding people with deep brain stimulation, recent antidepressant or MAOI use, major depression, unstable PD meds, serious heart/liver/kidney disease, pregnancy, or recent substance abuse.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 3 years and 7 months.