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RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Psilocybin (drug) for Depression

This study wants to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.

Official registry: https://clinicaltrials.gov/study/NCT07610369 · Yale University · enrollment listed as 40

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Psilocybin (drug), or Psilocybin (drug). The registry lists allocation as randomized. This study wants to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.

They plan to enroll about 40 people at New Haven. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease

Interventions: Psilocybin (drug), Psilocybin (drug)

Primary outcome (registry wording): Change in depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS)

Who it is for (from inclusion criteria)

  • Ages 40 Years to 80 Years
  • Comfortable speaking and writing in English
  • Have neurologist-diagnosed idiopathic Parkinson's disease (PD), Hoehn and Yahr stages 1 to 3 during an "on" phase (time when medication/DBS for parkinsonian motor feature, including bradykinesia and rigidity is in effect)
  • Have no changes in medication or major surgical procedures anticipated for treatment duration
  • Have a score \>/=20 on the Beck Depression Inventory-2 (BDI-2), consistent with moderate or greater depressive symptom severity, at Baseline
  • Agree to consume approximately the same amount of caffeine-containing beverages that they usually consume before arriving at the research unit on the mornings of psilocybin administration sessions
  • Agree to avoid sedative-hypnotic medications (e.g., benzodiazepines, zolpidem, zopiclone, zaleplon) taken on an as-needed basis for a minimum of 5 half-lives prior to each psilocybin administration session and for 24 hours after each psilocybin administration session
  • Agree to avoid opioid medications taken on an as-needed basis for a minimum of 5 half-lives prior to each psilocybin administration session and for 24 hours after each psilocybin administration session

Public study contact (from the registry)

Sophie Holmes, PhD

203-685-4066

sophie.holmes@yale.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Related recruiting trials in this snapshot

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Not a traditional drug phase: Medtronic Activa Tremor Control System for Parkinson's Disease

Background: \- Deep brain stimulation (DBS) is an approved surgery for certain movement disorders, like Parkinson's disease, that do not respond well to other treatments. DBS uses a battery-powered device called a neurostimulator (like a pacemaker) that is placed under the skin in the chest.

NCT01581580 · Official ClinicalTrials.gov record · National Institute of Neurological Disorders and Stroke (NINDS)

FAQ about this NCT record

Is NCT07610369 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07610369?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07610369?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary