Attention Deficit Hyperactivity DisorderPhase 4NCT01764672
Effect of Methylphenidate on Connectivity
A Phase 4 study testing Methylphenidate in people with Attention Deficit Hyperactivity Disorder, run by Iris Sommer at 1 site in Netherlands.
Trial summary
The goal of the study is to use graph theory to examine how the organization of the functional brain network may be altered by the administration of methylphenidate. This effect is to be compared between methylphenidate intake and placebo intake, as well as between healthy adult males and adult males with a diagnosis… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Methylphenidate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteNetherlands
- Study dates
- Apr 2013to Apr 2015
- Phase
- Phase 4
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male sex
- Written informed consent
- For the Attention Deficit Hyperactivity Disorder group only: a diagnosis of Attention Deficit Hyperactivity Disorder
Who cannot join
- Age under 18 or > 40
- Previous or current medical, psychiatric, or neurological problems (with exception of Attention Deficit Hyperactivity Disorder group)
- Use of psychotropic medication
- Use of recreational drugs in the two weeks before start of the study
- Consuming an equivalent of > 5 cups of coffee per day
- Consuming three or more alcohol units per day
- The presence of one or more of the contraindications or warnings against the study drug as listed in the Summary of Product Characteristic
- Presence of any contraindication to Magnetic Resonance Imaging scanning (e.g. implanted metallic object or electronic device)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Methylphenidate on Resting State Connectivity in Healthy Controls and in Adults With Attention Deficit Hyperactivity Disorder.
The goal of the study is to use graph theory to examine how the organization of the functional brain network may be altered by the administration of methylphenidate. This effect is to be compared between methylphenidate intake and placebo intake, as well as between healthy adult males and adult males with a diagnosis of Attention Deficit Hyperactivity Disorder.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Methylphenidate, Placebo
- Keywords
- Attention Deficit Hyperactivity Disorder, Healthy Adults, Methylphenidate, Functional connectivity, Functional Magnetic Resonance Imaging
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Also called Ritalin
Oral dose 40mg (2 x 20mg)
PlaceboOther
Oral intake of 2 placebo tablets
| Study group | Role | What they receive |
|---|---|---|
| Attention Deficit Hyperactivity Disorder | Experimental | Adult males with Attention Deficit Hyperactivity disorder will participate in a crossover design and receive both methylphenidate and placebo on two separate days. Receives: Drug: Methylphenidate; Other: Placebo |
| Healthy adults | Experimental | Healthy male adults will participate in a crossover design and receive both methylphenidate and placebo on two separate days. Receives: Drug: Methylphenidate; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in functional connectivity as measured with functional Magnetic Resonance Imaging between participants who ingested methylphenidate and those who ingested placebo.
The primary objective in the current trial is to use graph theory to examine how the organization of the functional brain network may be altered by the administration of methylphenidate. The main question we intend to answer in this study, is whether, and if so to what extent, methylphenidate affects the organization of brain networks.
Measured: After the last patient has completed the last visit, which is expected to be two years after the start of the study
Secondary outcomes (3)
The difference in functional connectivity as measured by functional Magnetic Resonance Imaging between participants with Attention Deficit Hyperactivity Disorder and healthy controls.
To examine if any of the effects on brain connectivity differ between participants with Attention Deficit Hyperactivity Disorder versus healthy controls.
Measured: After the last patient has completed the last visit, which is expected to be two years after the start of the study
The correlation of graph metrics (as a measure of functional network organization) with performance (scores) on cognitive tasks and blood levels of methylphenidate.
To examine how a reorganization of brain networks as described in the primary objective is related to improvements in cognitive performance and to blood levels of methylphenidate.
Measured: After the last patient has completed the last visit, which is expected to be two years after the start of the study
The correlation of whole brain cortical thickness and white matter volume as measured with Magnetic Resonance Imaging with both graph metrics as measured with functional Magnetic Resonance Imaging and scores on cognitive tests.
To examine if certain network structures of the brain, such as cortical thickness and white matter volume, are related to susceptibility to medication efficacy and if the structural qualities are related to cognitive performance.
Measured: After the last patient has completed the last visit, which is expected to be two years after the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iris Sommer
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Brain Foundation
- Responsible party
- Sponsor-investigator, Iris Sommer, UMC Utrecht
- Investigators
- Iris EC Sommer, Prof, Dr., Study director, UMC UtrechtMartijn P Van den Heuvel, Dr., Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764672
- Sponsor's protocol ID
- 2012-005339-95
- Other IDs
- NL42603.041.12
- Status last verified
- Feb 2014
- First submitted
- 21 Dec 2012
- Last updated
- 26 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Methylphenidate on Resting State Connectivity in Healthy Controls and in Adults With Attention Deficit Hyperactivity Disorder.
- ClinicalTrials.gov ID
- NCT01764672
- Acronym / sponsor ID
- 2012-005339-95
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, Healthy Adults, Methylphenidate, Functional connectivity, Functional Magnetic Resonance Imaging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Iris SommerUniversity, hospital or other
- Collaborators
- Netherlands Brain Foundation
- Study start
- Apr 2013
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 9 Jan 2013 (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.
The goal of the study is to use graph theory to examine how the organization of the functional brain network may be altered by the administration of methylphenidate. This effect is to be compared between methylphenidate intake and placebo intake, as well as between healthy adult males and adult males with a diagnosis of Attention Deficit Hyperactivity Disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Attention Deficit Hyperactivity Disorder | Experimental | Drug: Methylphenidate, Other: PlaceboAdult males with Attention Deficit Hyperactivity disorder will participate in a crossover design and receive both methylphenidate and placebo on two separate days. |
| Healthy adults | Experimental | Drug: Methylphenidate, Other: PlaceboHealthy male adults will participate in a crossover design and receive both methylphenidate and placebo on two separate days. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male sex
- Written informed consent
- For the Attention Deficit Hyperactivity Disorder group only: a diagnosis of Attention Deficit Hyperactivity Disorder
Key exclusion criteria (8 listed)
- Age under 18 or > 40
- Previous or current medical, psychiatric, or neurological problems (with exception of Attention Deficit Hyperactivity Disorder group)
- Use of psychotropic medication
- Use of recreational drugs in the two weeks before start of the study
- Consuming an equivalent of > 5 cups of coffee per day
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 |
|---|---|---|
| MethylphenidateAlso: RitalinOral dose 40mg (2 x 20mg) | Drug | Attention Deficit Hyperactivity Disorder, Healthy adults |
| PlaceboOral intake of 2 placebo tablets | Other | Attention Deficit Hyperactivity Disorder, Healthy adults |
Primary outcome
The difference in functional connectivity as measured with functional Magnetic Resonance Imaging between participants who ingested methylphenidate and those who ingested placebo.
Time frame: After the last patient has completed the last visit, which is expected to be two years after the start of the study
The primary objective in the current trial is to use graph theory to examine how the organization of the functional brain network may be altered by the administration of methylphenidate. The main question we intend to answer in this study, is whether, and if so to what extent, methylphenidate affects the organization of brain networks.
3 secondary outcomes
The difference in functional connectivity as measured by functional Magnetic Resonance Imaging between participants with Attention Deficit Hyperactivity Disorder and healthy controls.
Time frame: After the last patient has completed the last visit, which is expected to be two years after the start of the study
The correlation of graph metrics (as a measure of functional network organization) with performance (scores) on cognitive tasks and blood levels of methylphenidate.
Time frame: After the last patient has completed the last visit, which is expected to be two years after the start of the study
The correlation of whole brain cortical thickness and white matter volume as measured with Magnetic Resonance Imaging with both graph metrics as measured with functional Magnetic Resonance Imaging and scores on cognitive tests.
Time frame: After the last patient has completed the last visit, which is expected to be two years after the start of the study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2014.
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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. This study is not recruiting at the moment.
Iris EC Sommer, Prof, Dr. study director
UMC Utrecht
Martijn P Van den Heuvel, Dr. principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylphenidate in people with Attention Deficit Hyperactivity Disorder, run by Iris Sommer 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 3 inclusion and 8 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: withdrawn, as of the sponsor's last update on 26 Feb 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
The difference in functional connectivity as measured with functional Magnetic Resonance Imaging between participants who ingested methylphenidate and those who ingested placebo. (time frame: After the last patient has completed the last visit, which is expected to be two years after the start of the study). 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 26 Feb 2014.