Psilocybin for Parkinson's (NCT07610369)
Studying medication for Parkinsons depression
- Trial ID
- NCT07610369
- Official Title
- The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease
- Goal
- Studying medication for Parkinsons depression
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- Yale University
- Study Type
- INTERVENTIONAL
- Enrollment
- 40 participants
- Conditions
- Depression, Parkinson's Disease (PD)
- Interventions
- Psilocybin (drug), Psilocybin (drug)
Summary For Families
The study is testing whether psilocybin therapy can reduce depression in people who also have Parkinson's disease. In a randomized, controlled design, participants will have two medically supervised sessions taking oral psilocybin at doses ranging from a microdose to a high dose, with psychotherapy before and after each session, and researchers will track changes in depression as well as motor and non-motor symptoms, thinking, and quality of life for three months. They are enrolling people aged 40 to 80 with neurologist-diagnosed early to moderate Parkinson's (stage 1 to 3 when their Parkinson's medicines are working) who have at least moderate depression on the Beck Depression Inventory and who meet other safety and screening requirements.
Locations
- Yale University, New Haven, Connecticut, United States
Making Contact: How to Call This Study Site
Who to ask for
Ask for the study coordinator. Some sites call this person the research coordinator. They are the right person for questions about joining a study. If you reach a front desk or a doctor's office scheduler, ask them to connect you with the research team for this study.
What to say
It is fine to read this out loud, word for word:
Hello, my name is ____. I am calling about a Parkinson's study at your site. The study number is NCT07610369. It is the one about "Studying medication for Parkinsons depression". Could I speak with the study coordinator about taking part?
If you are calling for a family member, use their name and mention that you help with their care.
What they will ask you
- The year of diagnosis
- Current medications and their doses
- Other health conditions
- Any procedures already done, such as deep brain stimulation (DBS)
- How far you are able to travel for study visits
- Whether a care partner can come to visits with you
What to have ready
- A written list of current medications and doses
- Your neurologist's name and phone number
- The diagnosis date. The year is enough.
- A recent visit summary from the neurologist, if you have one
What to ask them
- How many visits are there, and how long does each visit take? The listing already answers this: You will have two drug administration sessions, with follow-up continuing to 3 months after the second session. Ask the coordinator to confirm it still applies.
- Is travel, parking, or my time reimbursed?
- Is there a placebo group, and what is my chance of being in it? The listing already answers this: There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another. Ask the coordinator to confirm it still applies.
- Would I need to stop or pause any of my current medications?
- What happens when the study ends? Could I stay on the treatment if it helps?
What to expect
- Expect to wait a few days for a callback. A week is common. Calling or emailing again after that is fine and normal.
- Many callers do not end up joining. Screening out is common and is not a judgment about you or your health.
- Asking questions commits you to nothing. You can stop the process at any point.
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Psilocybin (drug). The study is testing whether psilocybin therapy can reduce depression in people who also have Parkinson's disease. In a randomized, controlled design, participants will have two medically supervised sessions taking oral psilocybin at doses ranging from a microdose to a high dose, with psychotherapy before and after each session, and researchers will track changes in depression as well as motor and non-motor symptoms, thinking, and quality of life for three months. They are enrolling people aged 40 to 80 with neurologist-diagnosed early to moderate Parkinson's (stage 1 to 3 when their Parkinson's medicines are working) who have at least moderate depression on the Beck Depression Inventory and who meet other safety and screening requirements.
- Who can participate?
- Participants must be between 40 Years and 80 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 4 years.
- 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?
- There is no placebo group. Everyone receives an active treatment; the study compares one treatment against another.
- How many visits does this trial involve?
- You will have two drug administration sessions, with follow-up continuing to 3 months after the second session.