Clinical trial NCT05711082: REALITY MONITORING
Official title: MONITORING OF REALITY AND DOPAMINE: A PHARMACOLOGICAL RESEARCH
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurosciences
Lead sponsor: Hôpital le Vinatier
Sponsor class: OTHER
First posted: 2023-02-02
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: MORDOR study will use a randomized, double dummy, placebo-controlled, three-arm crossover design.
Primary purpose: BASIC_SCIENCE

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.

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.

Eligibility 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

Primary outcomes:
measure: Reality-monitoring performance
timeFrame: One month
Secondary outcomes:
measure: Reaction times at the reality-monitoring task and scores of subjective confidence rating for reality-monitoring responses
timeFrame: One month
measure: Other cognitive tasks
timeFrame: One month
Other outcomes:
Locations:
city: Bron
country: France
facility: Centre Hospitalier le Vinatier
Study officials:
affiliation: Centre Hospitalier le Vinatier
name: FILIPE GALVAO
role: PRINCIPAL_INVESTIGATOR
References: