Psilocybin Therapy for Depression in Parkinson's Disease
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Psilocybin, Pimavanserin.
- Кому может быть актуально
- Состояния в реестре: Parkinson Disease, Depression. Базовые параметры: 40 лет — 80 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease
Обзор
The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.
Подробное описание
This is a randomized controlled trial of oral psilocybin therapy for depression in people with Parkinson's disease (PD). The primary goal is to examine efficacy of psilocybin therapy in this patient population. We will enroll 60 people ages 40 to 80 with clinically diagnosed early to moderate stage Parkinson's disease (Hoehn and Yahr Stage 1-3 during an "on" period), who meet criteria for moderate or greater depression severity and meet all other inclusion and exclusion criteria at screening. Participants will complete two drug administration sessions where they will each receive a dose of oral psilocybin ranging from low ("microdose") to high in a medically monitored setting with psychotherapeutic support. Participants will also complete a series of psychotherapy sessions before and after each drug administration session. Clinical assessments, neuroimaging, non-invasive brain stimulation, and peripheral blood draws will be used to quantify changes in depression, other non-motor and motor symptoms of PD, quality of life, and selected neural and blood-based biomarkers at multiple time points. Follow-up will continue to 3 months after the second session. Primary endpoints will evaluate efficacy, safety, and tolerability of study procedures. After posting of these trial results, this data will be combined with the data from the trial at Yale University (NCT07610369) for publication purposes.
Вмешательства
- Препарат Psilocybin
Single dose of psilocybin ranging from low ("microdose") to high delivered orally in two separate drug administration sessions with psychological support and monitoring. - Препарат Pimavanserin
Participants will receive either pimavanserin or placebo during their drug administration sessions.
Первичные конечные точки
- Evaluate the efficacy of psilocybin for improving depression in people living with Parkinson's disease [Срок оценки: Baseline to 30 days after first drug dose]
Вторичные конечные точки (10)
- Changes in depression severity [Срок оценки: 7 days after first drug dose to 90 days after second drug dose]
- Changes in clinician-assessed depression [Срок оценки: Baseline to 90 days after second drug dose]
- Changes in anxiety [Срок оценки: Baseline to 90 days after second drug dose]
- Changes in PD symptom severity [Срок оценки: Baseline to 90 days after second drug dose]
- Changes in Quality of Life [Срок оценки: Baseline to 90 days after second drug dose]
- Changes in cognitive performance [Срок оценки: Baseline to 90 days after second drug dose]
- Safety and tolerability of psilocybin therapy for depression in people with PD [Срок оценки: Baseline to 90 days after second drug dose]
- Changes in clinician-rated psychotic symptoms [Срок оценки: Baseline to 90 days after second drug dose]
- Subjective effects of psilocybin [Срок оценки: Up to 30 and 60 days after Baseline]
- Participant-reported acceptability of study procedures [Срок оценки: 30 days after second drug dose]
Критерии участия
Критерии включения
- Age 40 to 80
- 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)
- Currently experiencing depressive symptoms
- Able to attend all in-person visits at UCSF as well as virtual visits
- Have a primary care provider, neurologist, or psychiatrist who is actively managing or coordinating
Критерии исключения
- Psychotic symptoms involving loss of insight
- Significant cognitive impairment
- Regular use of medications that may have problematic interactions with psilocybin
- A health condition that makes this study unsafe or unfeasible, determined by study physicians
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Четверное слепое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- University of California, San Francisco — San Francisco
Идентификаторы
NCT: NCT06455293 · IRB#20-32641