Mirtazapine 15 MG for Parkinson's (NCT06530290)
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
Summary For Families
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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 3 years and 7 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- Will I get a placebo in this trial?
- This trial has 2 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- How many visits does this trial involve?
- Patients are evaluated at baseline and after 4 and 12 weeks during the 12-week treatment.