NeurosciencesMORDORNCT05711082
REALITY MONITORING AND DOPAMINE
A study testing Précurseur de la dopamine and antagoniste D2 in people with Neurosciences, run by Hôpital le Vinatier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurosciences
- What is being tested?
- Précurseur de la dopamine and antagoniste D2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2024to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier le Vinatier
Bron, 69678
Marine Mondino, 0437915565 ext. +33, marine.mondino@ch-le-vinatier.fr
Jérôme Brunelin, 0437915297 ext. +33, jerome.brunelin@ch-le-vinatier.fr
About this study
Official title: The Role of Dopamine in Reality Memory
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.
Read the 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.
- Conditions
- Neurosciences
- Being tested
- Précurseur de la dopamine, antagoniste D2, PLACEBO
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Précurseur de la dopamineOther
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 experiment in which speakers monitor their auditory feedback while speaking.
Speech Bayesian reasoning: This task is a home-made task investigating the influence of prior on speech processing. Subjects will be required to identify speech in ambiguous auditory stimuli. Visual Bayesian reasoning: This task investigates the influence of prior on visual processing. Subjects will be required to recognize morph between faces and house.
antagoniste D2Other
In the second condition, volunteers will receive Sulpiride 800 mg
PLACEBOOther
In the third condition, volunteers will receive placebo
| Study group | Role | What they receive |
|---|---|---|
| Dopamine precursor | Active comparator | 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. Receives: Other: Précurseur de la dopamine |
| D2 antagonist | Active comparator | In the second condition, volunteers will receive a D2 antagonist (Sulpiride, 800mg) Receives: Other: antagoniste D2 |
| PLACEBO | Placebo comparator | In the third condition, volunteers will receive a placebo (lactose) Receives: Other: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reality-monitoring performance
Measured with a behavioral task developed, validated and used in investigators lab.
During the memory retrieval phase, 48 words will be presented, including the 32 words presented during encoding as well as 16 new words. Subjects will be required to identify whether each word was previously heard, imagined or new. Three words lists will be used and assigned randomly depending on the substance condition (L-dopa, Sulpiride, placebo). Each verbal list will include 16 items with the "imagine hear" encoding condition and 16 items with the "listen" encoding condition.
A single measure including two variables of interest will account for the main evaluation criteria:
- The average conditional source-identification measure (ACSIM) which represents the overall ability to correctly retrieve the source, conditional on that item was recognized as already presented.
- The source misattributions,the number of confusions between heard and imagined events.
Measured: One month
Secondary outcomes (2)
Reaction times at the reality-monitoring task and scores of subjective confidence rating for reality-monitoring responses
Regarding reality-monitoring, a single test in which investigators will also measure the reaction times at the reality-monitoring task and scores of subjective confidence rating for reality-monitoring responses. The variable of interest will be the number of high-confident incorrect source-recognition responses. Investigators finally measure the vividness of each "imagined" or "listened" word with Visual Analogue Scales (VAS) from 0 to 100.
Measured: One month
Other cognitive tasks
In the same test investigators will measure the number of correct/incorrect responses and reaction times at the n-back working memory task.
- The effect of dopamine modulation on the ability the ability to determine our speech as self-generated will be measured with a self-monitoring task. Investigators measure the magnitude of a voice peak response reflecting the feeling of agency.
- The effect of dopamine modulation on perception will be evaluated with the performances measured during 2 home-made Bayesian reasoning tasks, evaluating speech processing and visual processing, respectively.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start15 Jan 2024
- Primary completion15 Jan 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeurosciencesStudies of the same condition, open and under way.
- More trials run by Hôpital le VinatierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- MORDOR study will use a randomized, double dummy, placebo-controlled, three-arm crossover design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- FILIPE GALVAO, Principal investigator, Centre Hospitalier le Vinatier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05711082
- Sponsor's protocol ID
- 2022-A01345-38
- Acronym
- MORDOR
- Status last verified
- Jun 2026
- First submitted
- 23 Jan 2023
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Dopamine in Reality Memory
- ClinicalTrials.gov ID
- NCT05711082
- Acronym / sponsor ID
- MORDOR / 2022-A01345-38
- Conditions
- Neurosciences
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 2 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- MORDOR study will use a randomized, double dummy, placebo-controlled, three-arm crossover design.
| Arm | Type | Receives |
|---|---|---|
| Dopamine precursor | Active comparator | Other: Précurseur de la dopamineIn 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. |
| D2 antagonist | Active comparator | Other: antagoniste D2In the second condition, volunteers will receive a D2 antagonist (Sulpiride, 800mg) |
| PLACEBO | Placebo comparator | Other: PLACEBOIn the third condition, volunteers will receive a placebo (lactose) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Précurseur de la dopamineIn 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 experiment in which speakers monitor their auditory feedback while speaking. Speech Bayesian reasoning: This task is a home-made task investigating the influence of prior on speech processing. Subjects will be required to identify speech in ambiguous auditory stimuli. Visual Bayesian reasoning: This task investigates the influence of prior on visual processing. Subjects will be required to recognize morph between faces and house. | Other | Dopamine precursor |
| antagoniste D2In the second condition, volunteers will receive Sulpiride 800 mg | Other | D2 antagonist |
| PLACEBOIn the third condition, volunteers will receive placebo | Other | PLACEBO |
Primary outcome
Reality-monitoring performance
Time frame: One month
Measured with a behavioral task developed, validated and used in investigators lab. During the memory retrieval phase, 48 words will be presented, including the 32 words presented during encoding as well as 16 new words. Subjects will be required to identify whether each word was previously heard, imagined or new. Three words lists will be used and assigned randomly depending on the substance condition (L-dopa, Sulpiride, placebo). Each verbal list will include 16 items with the "imagine hear" encoding condition and 16 items with the "listen" encoding condition. A single measure including two variables of interest will account for the main evaluation criteria: * The average conditional source-identification measure (ACSIM) which represents the overall ability to correctly retrieve the source, conditional on that item was recognized as already presented. * The source misattributions,the number of confusions between heard and imagined events.
2 secondary outcomes
Reaction times at the reality-monitoring task and scores of subjective confidence rating for reality-monitoring responses
Time frame: One month
Other cognitive tasks
Time frame: One month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
FILIPE GALVAO principal investigator
Centre Hospitalier le Vinatier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Précurseur de la dopamine and antagoniste D2 in people with Neurosciences, run by Hôpital le Vinatier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact JEROME BRUNELIN (0033437915565, jerome.brunelin@ch-le-vinatier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reality-monitoring performance (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.