Sulpiride's Effect on Striatal BOLD Signal During Working Memory GatingNCT05884671
Dopamine and Cognition
A study testing Sulpiride 400 MG in people with Sulpiride's Effect on Striatal BOLD Signal During Working Memory Gating and Interaction of Sulpiride, Average Reward Rate and Evidence Accumulation, run by Donders Centre for Cognitive Neuroimaging at 1 site in Netherlands.
Trial summary
Rationale: To unravel the role of dopamine in gating of working memory, motivation and learning. Objective: The primary objective of this study is to isolate effects of blocking D2 receptor stimulation on gating of working memory, reinforcement learning and reward-based motivation, and their associated physiological… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Sulpiride's Effect on Striatal BOLD Signal During Working Memory Gating, Interaction of Sulpiride, Average Reward Rate and Evidence Accumulation, Interaction of Sulpiride, Average Reward Rate and Cognitive Effort
- What is being tested?
- Sulpiride 400 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Sep 2021to 12 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 between 18 and 45 years of age
- Predominant right-handedness
Who cannot join
- Presence of prolactin-dependent tumors (e.g., pituitary prolactinoma or breast cancer)
- (History of) autonomic failure (e.g., vasovagal reflex syncope).
- (History of) clinically significant hepatic, cardiac, obstructive respiratory, renal, cerebrovascular, cardiovascular, metabolic, ocular or pulmonary disease/disorders
- (History of) epilepsy in adulthood (i.e. no insult after 18 years of age, no current medication for epilepsy and no insult in the last five years)
- Diagnosis (or history of) endocrine treatment
- Diagnosis (or history of) neuroendocrine treatment (e.g., phechromocytoma, hyperthyroidism, Cushing's syndrome)
Show all 41Show fewer
- (History of) melanoma
- Hypersensitivity to sulpiride
- One first degree or two or more second degree family members with a history of sudden death or ventricular arrhythmia
- Abnormal QT interval (assessed via ECG)
- Uncontrolled hypertension, defined as diastolic blood pressure at rest > 95 mmHg or systolic blood pressure at rest > 180 mmHg
- Hypotension, defined as diastolic blood pressure < 50 mm Hg or systolic < 95 mm Hg
- or resting pulse rate < 45 beats/min
- Diabetes
- History of prescribed medication within the last month prior to the start of the study.
- History of 'over the counter' medication within the last two months (with exception of occasional use of paracetamol, acetylsalicylic acid, and ibuprofen).
- Possible pregnancy or breastfeeding
- No appropriate contraception
- Undiagnosed skin lesions
- Lactose intolerance
- Glaucoma or increased risk for glaucoma
- Possible pregnancy or breastfeeding
- Metal objects in or around the body (braces, pacemaker, metal fragments, hearing devices)
- Claustrophobia
- Diagnosis (or history of) psychiatric treatment (e.g., severe depression, anorexia nervosa, severe mood disorders, mania, schizophrenia or borderline personality disorder)
- Diagnosis (or history of) neurological treatment
- (History of) drug dependence (opiate, LSD, (meth)amphetamine, cocaine, solvents, or barbiturate) or alcohol dependence
- Suicidality
- Use of MAO inhibitor, anaesthetic, antidepressant or antipsychotic drugs within the week prior to the start of the study.
- Average use of psychotropic medication or recreational drugs weekly or more.
- Cannabis use within 2 weeks prior to the start of the study, and periods of more than 3 months using weekly or more in the last 6 months
- Use of psychotropic medication, or of recreational drugs over a period of 72 hours
- prior to the test sessions, and use of alcohol within the last 24 hours before each measurement.
- Average use of more than 3 alcohol beverages daily.
- Average use of psychotropic medication or recreational drugs weekly or more.
- Habitual smoking, i.e., more than a pack of cigarettes per week and/or a self-reported inability or unease to cease smoking for 24 hours to testing.
- Regular use of corticosteroids.
- Abnormal hearing or (uncorrected) vision.
- First degree family member with schizophrenia or bipolar disorder
- Irregular sleep/wake rhythm (e.g., regular nightshifts or cross timezone travel).
- Left handedness (because lateralisations of brain activation may differ from right-handed people).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Donders Centre for Cognition, Radboud University
Nijmegen, Gelderland
About this study
Official title: Dopaminergic Mechanisms of Gating Working Memory, Learning and Motivation: a Pharmaco-fMRI Study
Rationale: To unravel the role of dopamine in gating of working memory, motivation and learning.
Objective: The primary objective of this study is to isolate effects of blocking D2 receptor stimulation on gating of working memory, reinforcement learning and reward-based motivation, and their associated physiological changes (measured with fMRI and eye tracking). The secondary objective is to assess the degree to which the effects of D2 receptor action vary as a function of proxy measures of baseline dopamine levels.
Read more
Study design: A double-blind placebo controlled within-subject design will be employed, in which young healthy participants are tested twice, once on placebo, and once on a low oral dose (400mg) of the D2 receptor antagonist sulpiride. This design and drug dose is commonly used in our lab without side effects (previously approved CMO protocols 2011/204, 2008/078 \& 2016/2646).
Study population: Healthy human participants, 18 - 45 yr old. We will recruit 46 participants.
Intervention: Participants will receive both 400 mg sulpiride and placebo, in separate sessions in a counterbalanced order.
Main study parameters/endpoints: BOLD signal measured with fMRI, and behavioural performance on cognitive tasks.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants will attend 3 study sessions: A screening session and 2 pharmaco-fMRI sessions (sulpiride and placebo). Participants will complete a baseline battery of tasks and questionnaires, a structural MRI scan, as well as a battery of tasks both in and outside the scanner. On the day preceding each pharmaco-fMRI session, participants will have to adhere to some simple restrictions with respect to medication, alcohol and drug intake. On the day of testing participants will have to refrain from smoking and stimulant-containing drinks. Sulpiride can be administered safely without any relevant risk of serious adverse events and has been approved for clinical use in the Netherlands.
Read the detailed description
A more detailed description can be found in the approved research protocol as well as the pre-registrations. The links to the pre-registrations will be made available upon publication.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulpiride 400 MGDrug
Also called Dogmatil
All participants will receive one single dose of 400mg sulpiride. None of the participants will receive repeated doses. In order for the fMRI data acquisition to coincide with the time-window of maximal drug effects represented by a combination of plasma kinetics and physiological effects we will administer the drug 90 minutes prior to fMRI data acquisition.
PlaceboDrug
All participants will receive placebo during one of the sessions.
| Study group | Role | What they receive |
|---|---|---|
| Sulpiride | Active comparator | All study participants receive both placebo and the active medication (sulpiride 400mg), in a within-subjects , double-blind, randomized design. Receives: Drug: Sulpiride 400 MG |
| Placebo | Placebo comparator | All study participants receive both placebo and the active medication (sulpiride 400mg), in a within-subjects , double-blind, randomized design. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Working memory gating task: Reaction time
Reaction time [ms] during selective vs. non-selective input- and output-gating to assess the ability (speed) to selectively input- and output-gate working memory representations at intervention (sulpiride) versus placebo.
Measured: Measured at intervention day 1, 115 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
Working memory gating task: Reaction time
Reaction time [ms] during selective vs. non-selective input- and output-gating to assess the ability (speed) to selectively input- and output-gate working memory representations at intervention (sulpiride) versus placebo.
Measured: Measured at intervention day 2, 115 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
Working memory gating task: Accuracy
Accuracy [%] during selective vs. non-selective input- and output-gating to assess the ability (correctness) to selectively input- and output-gate working memory representations at intervention (sulpiride) versus placebo.
Measured: Measured at intervention day 1, 115 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
Working memory gating task: Accuracy
Accuracy [%] during selective vs. non-selective input- and output-gating to assess the ability (correctness) to selectively input- and output-gate working memory representations at intervention (sulpiride) versus placebo.
Measured: Measured at intervention day 2, 115 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
Working memory gating task: BOLD-response
BOLD-response to selective vs. global cues, examined for both pre- and retro-cue conditions (i.e., input- and output-gating respectively) to assess the neural response to selective working memory gating at intervention (sulpiride) versus placebo.
Measured: Measured at intervention day 1, 115 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
Working memory gating task: BOLD-response
BOLD-response to selective vs. global cues, examined for both pre- and retro-cue conditions (i.e., input- and output-gating respectively) to assess the neural response to selective working memory gating at intervention (sulpiride) versus placebo.
Measured: Measured at intervention day 2, 115 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
Simon task: Accuracy
Accuracy [%] during high and low average reward rate congruent and incongruent trials to assess cognitive effort investment after intervention versus placebo.
Measured: Measured at intervention day 1, 250 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
Simon task: Accuracy
Accuracy [%] during high and low average reward rate congruent and incongruent trials to assess cognitive effort investment after intervention versus placebo.
Measured: Measured at intervention day 2, 250 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
Simon task: Reaction time
Reaction time [ms] during high and low average reward rate congruent and incongruent trials to assess cognitive effort investment after intervention versus placebo
Measured: Measured at intervention day 1, 250 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
Simon task: Reaction time
Reaction time [ms] during high and low average reward rate congruent and incongruent trials to assess cognitive effort investment after intervention versus placebo
Measured: Measured at intervention day 2, 250 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
Perceptual decision-making task: Accuracy
Accuracy [%] as a function of average reward rate to assess cognitive effort investment after intervention versus placebo.
Measured: Measured at intervention day 1, 215 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
Perceptual decision-making task: Accuracy
Accuracy [%] as a function of average reward rate to assess cognitive effort investment after intervention versus placebo.
Measured: Measured at intervention day 2, 215 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
Perceptual decision-making task: Reaction time
Reaction time [ms] as a function of average reward rate to assess cognitive effort investment after intervention versus placebo.
Measured: Measured at intervention day 1, 215 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
Perceptual decision-making task: Reaction time
Reaction time [ms] as a function of average reward rate to assess cognitive effort investment after intervention versus placebo.
Measured: Measured at intervention day 2, 215 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
Secondary outcomes (11)
Eye-blink rate
Number of spontaneous eye blinks per minute, as a clinically relevant biomarker of striatal dopamine function
Measured: Measured at baseline during intake session
Operation Span test
Number of letters remembered while performing math problems, as a parameter for working memory capacity
Measured: Measured at baseline during intake session
Digit Span test
Accuracy score [nr of correct responses] on forward span and backward span, as a parameter for working memory capacity
Measured: Measured at baseline during intake session
Digit Span test
Accuracy score [nr of correct responses] on forward span and backward span, as a parameter for working memory capacity
Measured: Measured during intervention day 1 (sessions at least 14 days apart), 290 min after the pharmacological intervention took place
Digit Span test
Accuracy score [nr of correct responses] on forward span and backward span, as a parameter for working memory capacity
Measured: Measured during intervention day 2 (sessions at least 14 days apart), 290 min after the pharmacological intervention took place
Beck Depression Inventory
Average score as indicator of depressive symptoms
Measured: Baseline measure via online questionnaire in between first and second intervention session (these take place at least 14 days apart)
Barratt Impulsiveness Scale
Average score as indicator of impulsivity (personality trait)
Measured: Baseline measure via online questionnaire in between first and second intervention session (these take place at least 14 days apart)
Behavioural Inhibition Scale/Behavioural Activation Scale
Average score as indicator of behavioural activation and inhibition
Measured: Baseline measure via online questionnaire in between first and second intervention session (these take place at least 14 days apart)
State and Trait Anxiety Inventory
Average score as indicator of state and trait anxiety
Measured: Baseline measure via online questionnaire in between first and second intervention session (these take place at least 14 days apart)
Utrechtse Burnout Schaal/Maslach Burnout Inventory
Average score as indicator of burn out
Measured: Baseline measure via online questionnaire in between first and second intervention session (these take place at least 14 days apart)
Covid-19 Stress Scales
Average score as indicator of COVID-related stress and anxiety
Measured: Baseline measure via online questionnaire in between first and second intervention session (these take place at least 14 days apart)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start23 Sep 2021
- Primary completion12 Jul 2022
- Study completion12 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sulpiride's Effect on Striatal BOLD Signal During Working Memory GatingStudies of the same condition, open and under way.
- 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
- This is a within-subjects (i.e., crossover), double-blind, randomized placebo-controlled study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Donders Centre for Cognitive Neuroimaging
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Dr. Robbert-Jan Verkes, Radboud University Medical Centre Department of Psychiatry, Funding: NWO + KNAW
- Responsible party
- Principal investigator, Roshan Cools, Donders Centre for Cognitive Neuroimaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05884671
- Sponsor's protocol ID
- 3017048.09
- Status last verified
- Sep 2023
- First submitted
- 21 Mar 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Following publication, raw and processed data will be archived for scientific integrity. The data use agreement gives access to the data, provided that certain conditions set by the local institutional guidelines as well as (inter)national (EU) law are met. Data sharing will be done using the Donders Institute research data repository (http://data.donders.ru.nl) in accordance to institutional and EU guidelines.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopaminergic Mechanisms of Gating Working Memory, Learning and Motivation: a Pharmaco-fMRI Study
- ClinicalTrials.gov ID
- NCT05884671
- Acronym / sponsor ID
- 3017048.09
- Conditions
- Sulpiride's Effect on Striatal BOLD Signal During Working Memory Gating, Interaction of Sulpiride, Average Reward Rate and Evidence Accumulation, Interaction of Sulpiride, Average Reward Rate and Cognitive Effort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Donders Centre for Cognitive NeuroimagingUniversity, hospital or other
- Collaborators
- Prof. Dr. Robbert-Jan Verkes, Radboud University Medical Centre Department of Psychiatry, Funding: NWO + KNAW
- Study start
- 23 Sep 2021 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 1 Jun 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.
Rationale: To unravel the role of dopamine in gating of working memory, motivation and learning.
Objective: The primary objective of this study is to isolate effects of blocking D2 receptor stimulation on gating of working memory, reinforcement learning and reward-based motivation, and their associated physiological changes (measured with fMRI and eye tracking). The secondary objective is to assess the degree to which the effects of D2 receptor action vary as a function of proxy measures of baseline dopamine levels.
Study design: A double-blind placebo controlled within-subject design will be employed, in which young healthy participants are tested twice, once on placebo, and once on a low oral dose (400mg) of the D2 receptor antagonist sulpiride. This design and drug dose is commonly used in our lab without side effects (previously approved CMO protocols 2011/204, 2008/078 \& 2016/2646).
Study population: Healthy human participants, 18 - 45 yr old. We will recruit 46 participants.
Intervention: Participants will receive both 400 mg sulpiride and placebo, in separate sessions in a counterbalanced order.
Main study parameters/endpoints: BOLD signal measured with fMRI, and behavioural performance on cognitive tasks.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants will attend 3 study sessions: A screening session and 2 pharmaco-fMRI sessions (sulpiride and placebo). Participants will complete a baseline battery of tasks and questionnaires, a structural MRI scan, as well as a battery of tasks both in and outside the scanner. On the day preceding each pharmaco-fMRI session, participants will have to adhere to some simple restrictions with respect to medication, alcohol and drug intake. On the day of testing participants will have to refrain from smoking and stimulant-containing drinks. Sulpiride can be administered safely without any relevant risk of serious adverse events and has been approved for clinical use in the Netherlands.
Detailed description
A more detailed description can be found in the approved research protocol as well as the pre-registrations. The links to the pre-registrations will be made available upon publication.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a within-subjects (i.e., crossover), double-blind, randomized placebo-controlled study.
| Arm | Type | Receives |
|---|---|---|
| Sulpiride | Active comparator | Drug: Sulpiride 400 MGAll study participants receive both placebo and the active medication (sulpiride 400mg), in a within-subjects , double-blind, randomized design. |
| Placebo | Placebo comparator | Drug: PlaceboAll study participants receive both placebo and the active medication (sulpiride 400mg), in a within-subjects , double-blind, randomized design. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy volunteers between 18 and 45 years of age
- Predominant right-handedness
Key exclusion criteria (41 listed)
- Presence of prolactin-dependent tumors (e.g., pituitary prolactinoma or breast cancer)
- (History of) autonomic failure (e.g., vasovagal reflex syncope).
- (History of) clinically significant hepatic, cardiac, obstructive respiratory, renal, cerebrovascular, cardiovascular, metabolic, ocular or pulmonary disease/disorders
- (History of) epilepsy in adulthood (i.e. no insult after 18 years of age, no current medication for epilepsy and no insult in the last five years)
- Diagnosis (or history of) endocrine treatment
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 |
|---|---|---|
| Sulpiride 400 MGAlso: DogmatilAll participants will receive one single dose of 400mg sulpiride. None of the participants will receive repeated doses. In order for the fMRI data acquisition to coincide with the time-window of maximal drug effects represented by a combination of plasma kinetics and physiological effects we will administer the drug 90 minutes prior to fMRI data acquisition. | Drug | Sulpiride |
| PlaceboAll participants will receive placebo during one of the sessions. | Drug | Placebo |
Primary outcome
Working memory gating task: Reaction time
Time frame: Measured at intervention day 1, 115 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
Reaction time [ms] during selective vs. non-selective input- and output-gating to assess the ability (speed) to selectively input- and output-gate working memory representations at intervention (sulpiride) versus placebo.
Working memory gating task: Reaction time
Time frame: Measured at intervention day 2, 115 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
Reaction time [ms] during selective vs. non-selective input- and output-gating to assess the ability (speed) to selectively input- and output-gate working memory representations at intervention (sulpiride) versus placebo.
Working memory gating task: Accuracy
Time frame: Measured at intervention day 1, 115 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
Accuracy [%] during selective vs. non-selective input- and output-gating to assess the ability (correctness) to selectively input- and output-gate working memory representations at intervention (sulpiride) versus placebo.
Working memory gating task: Accuracy
Time frame: Measured at intervention day 2, 115 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
Accuracy [%] during selective vs. non-selective input- and output-gating to assess the ability (correctness) to selectively input- and output-gate working memory representations at intervention (sulpiride) versus placebo.
Working memory gating task: BOLD-response
Time frame: Measured at intervention day 1, 115 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
BOLD-response to selective vs. global cues, examined for both pre- and retro-cue conditions (i.e., input- and output-gating respectively) to assess the neural response to selective working memory gating at intervention (sulpiride) versus placebo.
Working memory gating task: BOLD-response
Time frame: Measured at intervention day 2, 115 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
BOLD-response to selective vs. global cues, examined for both pre- and retro-cue conditions (i.e., input- and output-gating respectively) to assess the neural response to selective working memory gating at intervention (sulpiride) versus placebo.
Simon task: Accuracy
Time frame: Measured at intervention day 1, 250 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
Accuracy [%] during high and low average reward rate congruent and incongruent trials to assess cognitive effort investment after intervention versus placebo.
Simon task: Accuracy
Time frame: Measured at intervention day 2, 250 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
Accuracy [%] during high and low average reward rate congruent and incongruent trials to assess cognitive effort investment after intervention versus placebo.
Simon task: Reaction time
Time frame: Measured at intervention day 1, 250 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
Reaction time [ms] during high and low average reward rate congruent and incongruent trials to assess cognitive effort investment after intervention versus placebo
Simon task: Reaction time
Time frame: Measured at intervention day 2, 250 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
Reaction time [ms] during high and low average reward rate congruent and incongruent trials to assess cognitive effort investment after intervention versus placebo
Perceptual decision-making task: Accuracy
Time frame: Measured at intervention day 1, 215 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
Accuracy [%] as a function of average reward rate to assess cognitive effort investment after intervention versus placebo.
Perceptual decision-making task: Accuracy
Time frame: Measured at intervention day 2, 215 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
Accuracy [%] as a function of average reward rate to assess cognitive effort investment after intervention versus placebo.
Perceptual decision-making task: Reaction time
Time frame: Measured at intervention day 1, 215 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
Reaction time [ms] as a function of average reward rate to assess cognitive effort investment after intervention versus placebo.
Perceptual decision-making task: Reaction time
Time frame: Measured at intervention day 2, 215 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).
Reaction time [ms] as a function of average reward rate to assess cognitive effort investment after intervention versus placebo.
11 secondary outcomes
Eye-blink rate
Time frame: Measured at baseline during intake session
Operation Span test
Time frame: Measured at baseline during intake session
Digit Span test
Time frame: Measured at baseline during intake session
Digit Span test
Time frame: Measured during intervention day 1 (sessions at least 14 days apart), 290 min after the pharmacological intervention took place
Digit Span test
Time frame: Measured during intervention day 2 (sessions at least 14 days apart), 290 min after the pharmacological intervention took place
Beck Depression Inventory
Time frame: Baseline measure via online questionnaire in between first and second intervention session (these take place at least 14 days apart)
Barratt Impulsiveness Scale
Time frame: Baseline measure via online questionnaire in between first and second intervention session (these take place at least 14 days apart)
Behavioural Inhibition Scale/Behavioural Activation Scale
Time frame: Baseline measure via online questionnaire in between first and second intervention session (these take place at least 14 days apart)
State and Trait Anxiety Inventory
Time frame: Baseline measure via online questionnaire in between first and second intervention session (these take place at least 14 days apart)
Utrechtse Burnout Schaal/Maslach Burnout Inventory
Time frame: Baseline measure via online questionnaire in between first and second intervention session (these take place at least 14 days apart)
Covid-19 Stress Scales
Time frame: Baseline measure via online questionnaire in between first and second intervention session (these take place at least 14 days apart)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: Yes. Following publication, raw and processed data will be archived for scientific integrity. The data use agreement gives access to the data, provided that certain conditions set by the local institutional guidelines as well as (inter)national (EU) law are met. Data sharing will be done using the Donders Institute research data repository (http://data.donders.ru.nl) in accordance to institutional and EU guidelines.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sulpiride 400 MG in people with Sulpiride's Effect on Striatal BOLD Signal During Working Memory Gating and Interaction of Sulpiride, Average Reward Rate and Evidence Accumulation, run by Donders Centre for Cognitive Neuroimaging at 1 site in Netherlands.
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 2 inclusion and 41 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: finished, as of the sponsor's last update on 21 Sep 2023. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Working memory gating task: Reaction time (time frame: Measured at intervention day 1, 115 min after the pharmacological intervention took place. Measurements are compared regarding intervention type (drug versus placebo).). The study lists 14 primary outcomes in all. 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 21 Sep 2023.