Dopamine ActivityNCT01218425
Dopaminergic Modulation of Cognition and Psychomotor Function
A study testing Methylphenidate 40 mg, Levodopa/carbidopa 125 mg and Domperidon 10 mg in people with Dopamine Activity and Episodic Memory Consolidation, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
A recent study at our lab showed increased episodic memory consolidation and response readiness after treatment with methylphenidate in healthy volunteers. The investigators seek to replicate and extend these findings. Furthermore the pharmacological specificity of these effects will be studied. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dopamine Activity, Episodic Memory Consolidation, Response Preparation
- What is being tested?
- Methylphenidate 40 mg, Levodopa/carbidopa 125 mg and Domperidon 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2010to Jun 2012
- 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
- Male or female
- 18 to 45 years of age
- Healthy (i.e. absence of all exclusion criteria), normal static binocular acuity (corrected or uncorrected),
- Body mass index between 18.5 and 30
- Willingness to sign an informed consent.
Who cannot join
- history of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, haematological or psychiatric illness.
- history of depression, bipolar disorder, anxiety disorder, panic disorder, psychosis, or attention deficit hyperactivity disorder will be excluded from participation.
- first-degree relative with a psychiatric disorder or a history with a psychiatric disorder
- excessive drinking (>20 glasses of alcohol containing beverages a week
- pregnancy or lactation
- use of medication other than oral contraceptives
Show all 9Show fewer
- use of recreational drugs from 2 weeks before until the end of the experiment
- any condition in which gastrointestinal motility might carry any risk
- any sensory or motor deficits which could reasonably be expected to affect test performance
Trial locations and contacts
1 site in 1 country.
About this study
A recent study at our lab showed increased episodic memory consolidation and response readiness after treatment with methylphenidate in healthy volunteers. The investigators seek to replicate and extend these findings. Furthermore the pharmacological specificity of these effects will be studied. Since methylphenidate has an effect on two neurotransmitters, dopamine and noradrenaline, either could be responsible for the observed effects. In order to explore the dopaminergic contribution to this effect, the study proposed here includes not only methylphenidate but also levodopa/carbidopa, which only affects dopamine and not noradrenaline.
In this study, 20 healthy males and females between 18 and 45 years of age will participate. They will be recruited via advertisements at Maastricht University and in local newspapers.
Read more
Participants will be treated once with methylphenidate, once with levodopa/carbidopa and once with placebo. All medications will be administered orally with a capsule.
It is hypothesized that methylphenidate and levodopa/carbidopa will both enhance episodic memory consolidation and improve response readiness
- Being tested
- Methylphenidate 40 mg, Levodopa/carbidopa 125 mg, Domperidon 10 mg
- Keywords
- dopamine, EEG, episodic memory, contingent negative variation, response preparation, levodopa, methylphenidate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylphenidate 40 mgDrug
Also called Ritalin RVG 03957
Oral dose 40 mg
Levodopa/carbidopa 125 mgDrug
Also called Sinemet RVG08740
oral dose, 100 mg levodopa, 25 mg carbidopa in one capsule
Domperidon 10 mgDrug
Also called Domperidon RVG 23565
Domperidon 10 mg
| Study group | Role | What they receive |
|---|---|---|
| Medication | Experimental | In this study, a crossover design is applied. All participants receive all three treatments in randomized order on separate days. Receives: Drug: Methylphenidate 40 mg; Drug: Levodopa/carbidopa 125 mg; Drug: Domperidon 10 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral score on the Word learning test
Number of words recalled in the word learning test
Measured: 1 day
Secondary outcomes (2)
CNV amplitude
Amplitude of the CNV wave in the EEG
Measured: 1 day
Reaction time on the CNV
Reaction time in the response preparation task in which CNV is measured
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study startNov 2010
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dopamine ActivityStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Vuurman, Dr., Principal investigator, Dept Neuropsychology and Psychopharmacology, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218425
- Sponsor's protocol ID
- 10-3-056
- Status last verified
- Oct 2012
- First submitted
- 22 Sep 2010
- Last updated
- 25 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopaminergic Modulation of Cognition and Psychomotor Function
- ClinicalTrials.gov ID
- NCT01218425
- Acronym / sponsor ID
- 10-3-056
- Keywords
- dopamine, EEG, episodic memory, contingent negative variation, response preparation, levodopa, methylphenidate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 11 Oct 2010 (estimated)
- 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.
A recent study at our lab showed increased episodic memory consolidation and response readiness after treatment with methylphenidate in healthy volunteers. The investigators seek to replicate and extend these findings. Furthermore the pharmacological specificity of these effects will be studied. Since methylphenidate has an effect on two neurotransmitters, dopamine and noradrenaline, either could be responsible for the observed effects. In order to explore the dopaminergic contribution to this effect, the study proposed here includes not only methylphenidate but also levodopa/carbidopa, which only affects dopamine and not noradrenaline.
In this study, 20 healthy males and females between 18 and 45 years of age will participate. They will be recruited via advertisements at Maastricht University and in local newspapers.
Participants will be treated once with methylphenidate, once with levodopa/carbidopa and once with placebo. All medications will be administered orally with a capsule.
It is hypothesized that methylphenidate and levodopa/carbidopa will both enhance episodic memory consolidation and improve response readiness
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Medication | Experimental | Drug: Methylphenidate 40 mg, Drug: Levodopa/carbidopa 125 mg, Drug: Domperidon 10 mgIn this study, a crossover design is applied. All participants receive all three treatments in randomized order on separate days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female
- 18 to 45 years of age
- Healthy (i.e. absence of all exclusion criteria), normal static binocular acuity (corrected or uncorrected),
- Body mass index between 18.5 and 30
- Willingness to sign an informed consent.
Key exclusion criteria (9 listed)
- history of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, haematological or psychiatric illness.
- history of depression, bipolar disorder, anxiety disorder, panic disorder, psychosis, or attention deficit hyperactivity disorder will be excluded from participation.
- first-degree relative with a psychiatric disorder or a history with a psychiatric disorder
- excessive drinking (>20 glasses of alcohol containing beverages a week
- pregnancy or lactation
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 |
|---|---|---|
| Methylphenidate 40 mgAlso: Ritalin RVG 03957Oral dose 40 mg | Drug | Medication |
| Levodopa/carbidopa 125 mgAlso: Sinemet RVG08740oral dose, 100 mg levodopa, 25 mg carbidopa in one capsule | Drug | Medication |
| Domperidon 10 mgAlso: Domperidon RVG 23565Domperidon 10 mg | Drug | Medication |
Primary outcome
Behavioral score on the Word learning test
Time frame: 1 day
Number of words recalled in the word learning test
2 secondary outcomes
CNV amplitude
Time frame: 1 day
Reaction time on the CNV
Time frame: 1 day
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 25 Oct 2012.
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.
Eric Vuurman, Dr. principal investigator
Dept Neuropsychology and Psychopharmacology, Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylphenidate 40 mg, Levodopa/carbidopa 125 mg and Domperidon 10 mg in people with Dopamine Activity and Episodic Memory Consolidation, run by Maastricht University Medical Center 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 5 inclusion and 9 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 25 Oct 2012. 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. 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?
Behavioral score on the Word learning test (time frame: 1 day). 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 25 Oct 2012; AzTrials last refreshed its copy on 6 Nov 2026.