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NCT05711082 | Recruiting | Neurosciences


REALITY MONITORING
Sponsor:

Vinatier Hospital

Brief Summary:

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.

Condition or disease

Neurosciences

Intervention/treatment

Dopamine precursor

Production listened

PLACEBO

Phase

Not Applicable

Detailed Description:

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.}}

Study Type : Interventional
Estimated Enrollment : 39 participants
Masking : Single
Masking Description : double dummy, placebo-controlled
Primary Purpose : Basic Science
Official Title : MONITORING OF REALITY AND DOPAMINE: A PHARMACOLOGICAL RESEARCH
Actual Study Start Date : January 15, 2024
Estimated Primary Completion Date : June 30, 2026
Estimated Study Completion Date : December 31, 2026
Arm Intervention/treatment

Active Comparator: Dopamine precursor

In the first condition, volunteers will receive a dopamine (DA) precursor (L-dopa, 100mg). L-dopa will be combined with a dose of an Aromatic amino acid decarboxylase inhibitor (Benserazide) 25mg to multiplicate its bioavailability and with a dose of domperidone 10mg (peripheral antagonist of DA) to minimize the risk of side effects.

Other: Dopamine precursor

Active Comparator: D2 antagonist

In the second condition, volunteers will receive a D2 antagonist (Sulpiride, 800mg)

Other: antagoniste D2

Placebo Comparator: PLACEBO

In the third condition, volunteers will receive a placebo (lactose)

Other: PLACEBO

Ages Eligible for Study: 18 Years to 45 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
Criteria
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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

REALITY MONITORING

Location Details


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REALITY MONITORING

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Locations


Recruiting

France,

Le Vinatier Hospital Center

Bron, France, 69678

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