Attention Deficit Hyperactivity DisorderBrookhavenNCT00580814
Brain Dopamine Function in Adults With ADHD
A study testing Experimental: methylphenidate treatment in people with Attention Deficit Hyperactivity Disorder, run by University of California, Irvine at 1 site in United States.
Trial summary
The purpose of the study is to investigate the functional state of dopamine cells and the dopamine transporter in ADHD subjects and controls to assess the effects of chronic methylphenidate treatment on dopamine cell function and dopamine transporter levels in ADHD subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Experimental: methylphenidate treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Apr 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Must give informed consent
- Must be between the ages of 18 and 45 years old.
- Must have a confirmed diagnosis of ADHD
- Must have scored on a rating scale that indicate a significant level of symptom severity.
- Must have a childhood history of ADHD must be documented using established test criteria.
- Must have had no previous medication treatment for ADHD except for a short term treatment period of less than three months, which should have occurred at least six months prior to the study.
- Must have an interest in receiving long-term medication treatment for ADHD.
Who cannot join
- Must not test positive for psychoactive drugs during a urine drug screen.
- Must not be pregnant.
- Must not be breastfeeding.
- Must have no past or present history of dependence on alcohol or other drugs of abuse except nicotine or caffeine.
- Must have no past or present history of a psychiatric disorder except ADHD.
- Must have no medical illness that may affect brain function.
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- Must not have taken medication that may affect brain function.
- Must not have had head trauma with loss of consciousness (> 30 minutes).
- Must not have significant anxiety or depression as determined by an established test.
- Must have no history of a significant learning disability.
- Must have no history of cardiovascular or endocrinological disease.
- Must have no history of coagulation disorder.
- Must have no history of sensitivity to lidocaine and/or prilocaine.
- Must have no history of claustrophobia.
- Contraindication to MRI environment (presence of any implanted metallic objects such as cardiac/neural pacemakers, defibrillators, aneurysm clips, certain heart valves, spinal nerve stimulators, artificial joints/limbs, shrapnel/bullets, metal fragments in their eyes, cochlear implants, hearing aids, dental implants).
- Must have no history of glaucoma.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCI Child Development Center
Irvine, California, 92612
About this study
The purpose of the study is to investigate the functional state of dopamine cells and the dopamine transporter in ADHD subjects and controls to assess the effects of chronic methylphenidate treatment on dopamine cell function and dopamine transporter levels in ADHD subjects.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Experimental: methylphenidate treatment
- Keywords
- Brookhaven, ADHD, Dopamine, methylphenidate, PET
- 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.
Experimental: methylphenidate treatmentDrug
Also called methylphenidate once daily for 12 months, doses individually titrated for efficacy
subjects received mehtylphenidate treatment for 12 months
| Study group | Role | What they receive |
|---|---|---|
| methylphenidate | Experimental | intervention is methylphenidate once daily for 12 months, doses individually titrated Receives: Drug: Experimental: methylphenidate treatment |
| No medication | No intervention | no methylphenidate treatment for non ADHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
DAT Availability
Striatal DAT availability as noted in PET scans post one year of methylphenidate treatment or no intervention.
The unit listed as binding potential (BPND) was measured with a dynamic PET scan protocol, using carbon-11 labeled cocaine, a radioligand with specific binding to DAT (which is inhibited by drugs that block DAT but not by drugs that block the norephephrine or serotonin transporters). This radiotracer was utilized to quantify DAT availability as non-displaceable binding potential using a standard kinetic model for reversible ligands.
The dynamic PET scans were started immediately after injection of [11C]cocaine (specific activity 0.5-1.5 Ci/uM at end of bombardment). Arterial blood was obtained to measure the concentration of unchanged [11C] cocaine in plasma for quantification of DAT availability.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startFeb 2006
- Primary completionMar 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, Duke University
- Responsible party
- Principal investigator, Coleen Cunningham, University of California, Irvine
- Investigators
- Tim Wigal, Ph.D., Principal investigator, UC Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00580814
- Sponsor's protocol ID
- 20054659
- Acronym
- Brookhaven
- Status last verified
- Aug 2024
- First submitted
- 4 Oct 2007
- Last updated
- 29 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wang GJ, Volkow ND, Wigal T, Kollins SH, Newcorn JH, Telang F, Logan J, Jayne M, Wong CT, Han H, Fowler JS, Zhu W, Swanson JM. Long-term stimulant treatment affects brain dopamine transporter level in patients with attention deficit hyperactive disorder. PLoS One. 2013 May 15;8(5):e63023. doi: 10.1371/journal.pone.0063023. Print 2013.
PubMed 23696790Volkow, N.d., Wand, G., Kollins., Wigal, T., Newcorn, J., Telang, F., Fowler, J., Solanto, M.V., Logan, J., Ma, Y., Pradham. K., Wong, C., Zhu, W. & Swanson, J.M. Dopamine Reward Pathway Disrupted in Patients with ADHD: Therapeutic Implications, Journal of American Medical Association.
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Dopamine Function in Adults With ADHD
- ClinicalTrials.gov ID
- NCT00580814
- Acronym / sponsor ID
- Brookhaven / 20054659
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Brookhaven, ADHD, Dopamine, methylphenidate, PET
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai, Duke University
- Study start
- Feb 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 27 Dec 2007 (estimated)
- Results
- Posted 29 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to investigate the functional state of dopamine cells and the dopamine transporter in ADHD subjects and controls to assess the effects of chronic methylphenidate treatment on dopamine cell function and dopamine transporter levels in ADHD subjects.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methylphenidate | Experimental | Drug: Experimental: methylphenidate treatmentintervention is methylphenidate once daily for 12 months, doses individually titrated |
| No medication | No intervention | –no methylphenidate treatment for non ADHD |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Must give informed consent
- Must be between the ages of 18 and 45 years old.
- Must have a confirmed diagnosis of ADHD
- Must have scored on a rating scale that indicate a significant level of symptom severity.
- Must have a childhood history of ADHD must be documented using established test criteria.
Key exclusion criteria (16 listed)
- Must not test positive for psychoactive drugs during a urine drug screen.
- Must not be pregnant.
- Must not be breastfeeding.
- Must have no past or present history of dependence on alcohol or other drugs of abuse except nicotine or caffeine.
- Must have no past or present history of a psychiatric disorder except ADHD.
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 |
|---|---|---|
| Experimental: methylphenidate treatmentAlso: methylphenidate once daily for 12 months, doses individually titrated for efficacysubjects received mehtylphenidate treatment for 12 months | Drug | methylphenidate |
Primary outcome
DAT Availability
Time frame: 1 year
Striatal DAT availability as noted in PET scans post one year of methylphenidate treatment or no intervention. The unit listed as binding potential (BPND) was measured with a dynamic PET scan protocol, using carbon-11 labeled cocaine, a radioligand with specific binding to DAT (which is inhibited by drugs that block DAT but not by drugs that block the norephephrine or serotonin transporters). This radiotracer was utilized to quantify DAT availability as non-displaceable binding potential using a standard kinetic model for reversible ligands. The dynamic PET scans were started immediately after injection of [11C]cocaine (specific activity 0.5-1.5 Ci/uM at end of bombardment). Arterial blood was obtained to measure the concentration of unchanged [11C] cocaine in plasma for quantification of DAT availability.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23696790Wang GJ, Volkow ND, Wigal T, Kollins SH, Newcorn JH, Telang F, Logan J, Jayne M, Wong CT, Han H, Fowler JS, Zhu W, Swanson JM. Long-term stimulant treatment affects brain dopamine transporter level in patients with attention deficit hyperactive disorder. PLoS One. 2013 May 15;8(5):e63023. doi: 10.1371/journal.pone.0063023. Print 2013.
- Results publicationVolkow, N.d., Wand, G., Kollins., Wigal, T., Newcorn, J., Telang, F., Fowler, J., Solanto, M.V., Logan, J., Ma, Y., Pradham. K., Wong, C., Zhu, W. & Swanson, J.M. Dopamine Reward Pathway Disrupted in Patients with ADHD: Therapeutic Implications, Journal of American Medical Association.
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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.
Tim Wigal, Ph.D. principal investigator
UC Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental: methylphenidate treatment in people with Attention Deficit Hyperactivity Disorder, run by University of California, Irvine at 1 site in United States.
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 7 inclusion and 16 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 29 Aug 2024. 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 United States. 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?
Yes. Results are posted in the registry (first posted 29 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
DAT Availability (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00580814, which also lists 2 linked publications.
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 29 Aug 2024.