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Идёт набор NCT05711082

REALITY MONITORING AND DOPAMINE

Без фазы С лечением Neurosciences

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: Précurseur de la dopamine, antagoniste D2, PLACEBO.
Кому может быть актуально
Состояния в реестре: Neurosciences. Базовые параметры: 18 лет — 45 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
Франция
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 Role of Dopamine in Reality Memory

Обзор

Reality-monitoring characterizes the ability to determine whether information was perceived in the environment or only imagined . Impaired reality-monitoring abilities have been associated with hallucinations in patients with schizophrenia and patients with Parkinson's disease. The investigators hypothesize a link between dopaminergic (DA) transmission and reality-monitoring.

Подробное описание

This hypothesis is based on several studies in the literature: 1) DA transmission anomalies are observed in both schizophrenia and Parkinson's disease; 2) DA agonists may induce hallucination; 3) DA antagonists reduce hallucinations and improve reality-monitoring abilities in patients with schizophrenia. In addition, also suggesting a link between mesocorticolimbic connectivity, subcortical DA transmission and reality-monitoring, The investigators have shown that fronto-temporal transcranial Direct Current Stimulation (tDCS) leads:

* on the one hand, to modulate reality-monitoring performance in healthy volunteers and patients; * on the other hand, to induce subcortical DA release. However, to date, no study has yet explored the direct link between DA transmission and reality-monitoring.

Вмешательства

  • Другое Précurseur de la dopamine
    In the first condition, volunteers will receive a 100mg dose of L-dopa, 25mg dose of Aromatic amino acid decarboxylase inhibitors (Benserazide) and 10mg dose of Domperidone. In the second condition, volunteers will receive Sulpiride 800mg. In the third condition, volunteers will receive placebo Reality-monitoring performances will be evaluated with a standardized task. Working-memory will be evaluated with the n-back task. Self-monitoring performances will be observed during a speech production
  • Другое antagoniste D2
    In the second condition, volunteers will receive Sulpiride 800 mg
  • Другое PLACEBO
    In the third condition, volunteers will receive placebo

Первичные конечные точки

  • Reality-monitoring performance [Срок оценки: One month]
Вторичные конечные точки (2)
  • Reaction times at the reality-monitoring task and scores of subjective confidence rating for reality-monitoring responses [Срок оценки: One month]
  • Other cognitive tasks [Срок оценки: One month]

Критерии участия

Критерии включения

  • Healthy volunteers who have given their written informed consent
  • Men and women from 18 to 45 years old
  • Normal or corrected vision
  • Being fluent in French or French for native language
  • Being affiliated with health insurance

Критерии исключения

  • Healthy volunteers who have given their written informed consent
  • Men and women from 18 to 45 years old
  • Normal or corrected vision
  • Being fluent in French or French for native language
  • Being affiliated with health insurance
  • Inadmissibility of the subject's consent or refusal
  • Working-memory deficit (as controlled with MMSE score< 23)
  • Any past or current psychiatric or somatic condition(as controlled with the Mini International Neuropsychiatric Interview, MINI)
  • Any past or current neurological condition
  • History of cranio-cerebral trauma, arterial hypotension or hypertension, cardiological or serious medical condition
  • Abnormal potassium dosage (below 3.1 mmol/L or above 4.9 mmol/L)
  • Anormal ECG
  • History of schizophrenia or bipolar disorder in first-degree relatives
  • Alcohol-drinking and caffeine intake at least during 24 hours before each session
  • Drug therapy excepting contraceptives
  • Cardiologic or severe medical conditio
  • Pregnancy(checked with a pregnancy autotest), lactation, or insufficient contraceptive measure (precautionary measure)
  • Consumption of recreational drugs during the last 6 months
  • Known sensitivity to any of the study medication and their excipients
  • Lactose intolerance
  • Porphyria
  • Hepatic insufficiency

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Перекрёстный дизайн
Маскирование
Простое слепое
Основная цель
Фундаментальное исследование

Центры проведения

Франция · 1 центр
  • Centre Hospitalier le Vinatier — Bron

Идентификаторы

NCT: NCT05711082 · 2022-A01345-38

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗