Attention Deficit Hyperactivity DisorderNCT00302380
An Open Label Phase I/II Study of the Safety and Dopamine Transporter Binding Properties of C-11 Altropane in Normal Human Subjects and in Subjects With ADHD
An observational study of Attention Deficit Hyperactivity Disorder, run by Massachusetts General Hospital.
Trial summary
The primary objective of this study is to evaluate the Binding Potential in subjects with ADHD and adults without ADHD: the intent being to demonstrate that C-11 Altropane PET can be used to differentiate adults with ADHD from healthy control subjects. Read more about this study
- Who is it for?
- Ages 18 months to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- PET imaging using C-11 altropane as the ligand.
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Oct 2000to Mar 2006
- Phase
- Observational
- 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 months to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 200 un-medicated subjects with ADHD and 100 subjects without ADHD will be recruited sequentially. No individual will be excluded based on gender, race, or ethnicity.
Who may be able to join
- Signed written informed consent to participate in the study.
- Age: 18 - 55
- If female, non-pregnant, non-nursing with a negative serum pregnancy test and using an adequate form of birth control.
- Supine and standing blood pressure within the range 110/60 to 150/90 mmHg.
- Heart rate, after resting for 5 minutes, within the range 46-90 beats/min.
- Subjects who are within 20% of the ideal weight for height
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- Right handed
- Diagnosis of DSM-IV ADHD (current), as manifested in clinical evaluation and confirmed by structured interview (for ADHD study subjects).
- Subjects without a diagnosis of DSM-IV ADHD (lifetime), as manifested in clinical evaluation and confirmed by structured interview (for control study subjects).
Who cannot join
- Diagnosis of any psychotic disorder, bipolar disorder, severe depression, severe anxiety, or Autism. Subjects with mild mood, oppositional, conduct, and anxiety disorders may be permitted to participate if considered appropriate by the investigator
- Scores of Baseline Scales:
- Hamilton Depression Scale > 17 (out of a possible 67 on the 21-item scale)(Hamilton 1960) Beck Depression Inventory > 19 (out of a possible 63 on the 21-item scale)(Beck, Ward et al. 1961) Hamilton Anxiety Scale > 21 (out of a possible 56 on the 14-item scale)(Hamilton 1959)
- History of head trauma with loss of consciousness, organic brain disorders, seizures, or neurosurgical intervention.
- Any clinically significant chronic medical condition, in the judgement of the investigator.
- Mental impairment as evidenced by an I.Q. <75.
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- Subject must be off any investigational drug for at least 4 weeks prior to the start of the study.
- Exposure to dopamine receptor antagonists, including stimulant medications (e.g. methylphenidate) or buproprion within the previous three (3) months to the start of the study.
- Exposure to non-stimulant ADHD medications (e.g. atomoxetine) within the previous 4 weeks to the start of the study.
- Exposure to radiopharmaceuticals within four (4) weeks prior to PET scan.
- Subjects receiving psychotropic medication.
- Any clinically significant abnormality in the screening laboratory tests, vital signs, or 12-lead ECG, outside of normal limits.
- Any woman of childbearing potential who is seeking to become pregnant or suspects that she may be pregnant.
- Subjects with a known recent history (within the past six (6) months) of illicit drug or alcohol dependence.
About this study
The primary objective of this study is to evaluate the Binding Potential in subjects with ADHD and adults without ADHD: the intent being to demonstrate that C-11 Altropane PET can be used to differentiate adults with ADHD from healthy control subjects.
Read the detailed description
This protocol seeks to replicate and extend our investigation of DAT binding in adults with ADHD with specific aims:
- To examine dopamine transporter (DAT) receptor binding potential in adults with ADHD, using PET scanning with 11C altropane as the ligand. We hypothesize that compared to adults without ADHD, adults with ADHD will have greater DAT binding that will not be accounted by psychiatric comorbidity or age.
- To examine the relationship of DAT binding to clinical features of ADHD. We hypothesize that DAT binding will be positively correlated with a) severity of ADHD symptoms and b) neuropsychological and interpersonal dysfunction.
- To examine the relationship between DAT binding and genetic risk factors. We hypothesize that DAT binding will be specifically associated with homozygosity of the DAT (480) gene in adults with ADHD and not with other ADHD-associated genetic markers (e.g., DRD4-7, D2, DBH).
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- PET imaging using C-11 altropane as the ligand.
- 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.
PET imaging using C-11 altropane as the ligand.Radiation
A one-injection protocol will be used for the study. C-11 Altropane will be injected manually as an intravenous bolus.
| Study group | Role | What they receive |
|---|---|---|
| un-medicated subjects with ADHD | Not described Receives: Radiation: PET imaging using C-11 altropane as the ligand. | |
| subjects without ADHD | Not described Receives: Radiation: PET imaging using C-11 altropane as the ligand. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The DAT receptor occupancy of OROS MPH and Metadate CD in adults with and without ADHD using PET scanning with C-11 Altropane.
PET imaging will be acquired using either a HR+ or Siemens Biograph 64 PET/CT camera.
Measured: Subjects will lie still in the PET camera for a 90 minute period.
Secondary outcomes (2)
Neuropsychological tests
Cognitive-neuropsychological functioning will be examined by selected tests that are thought to reflect basic deficits in ADHD, mainly those believed to measure components of attention and prefrontal brain systems.
Measured: Examination of cognitive-neuropsychological functioning will take approximately 2.5 hours to complete.
Genotyping
Genotyping will be performed using a custom markers for dopamine-related genes (DAT, DRD4-7, D2, and DBH).
Measured: A sample of blood (2 tablespoons) will be drawn from all subjects.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2006 (estimated)
- Study startOct 2000
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Thomas Spencer, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00302380
- Sponsor's protocol ID
- 2000-p-001975
- Status last verified
- Jun 2011
- First submitted
- 10 Mar 2006
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Spencer TJ, Biederman J, Faraone SV, Madras BK, Bonab AA, Dougherty DD, Batchelder H, Clarke A, Fischman AJ. Functional genomics of attention-deficit/hyperactivity disorder (ADHD) risk alleles on dopamine transporter binding in ADHD and healthy control subjects. Biol Psychiatry. 2013 Jul 15;74(2):84-9. doi: 10.1016/j.biopsych.2012.11.010. Epub 2012 Dec 27.
PubMed 23273726
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Phase I/II Study of the Safety and Dopamine Transporter Binding Properties of C-11 Altropane in Normal Human Subjects and in Subjects With ADHD
- ClinicalTrials.gov ID
- NCT00302380
- Acronym / sponsor ID
- 2000-p-001975
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Oct 2000
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 14 Mar 2006 (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 primary objective of this study is to evaluate the Binding Potential in subjects with ADHD and adults without ADHD: the intent being to demonstrate that C-11 Altropane PET can be used to differentiate adults with ADHD from healthy control subjects.
Detailed description
This protocol seeks to replicate and extend our investigation of DAT binding in adults with ADHD with specific aims:
- To examine dopamine transporter (DAT) receptor binding potential in adults with ADHD, using PET scanning with 11C altropane as the ligand. We hypothesize that compared to adults without ADHD, adults with ADHD will have greater DAT binding that will not be accounted by psychiatric comorbidity or age.
- To examine the relationship of DAT binding to clinical features of ADHD. We hypothesize that DAT binding will be positively correlated with a) severity of ADHD symptoms and b) neuropsychological and interpersonal dysfunction.
- To examine the relationship between DAT binding and genetic risk factors. We hypothesize that DAT binding will be specifically associated with homozygosity of the DAT (480) gene in adults with ADHD and not with other ADHD-associated genetic markers (e.g., DRD4-7, D2, DBH).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| un-medicated subjects with ADHD | – | Radiation: PET imaging using C-11 altropane as the ligand. |
| subjects without ADHD | – | Radiation: PET imaging using C-11 altropane as the ligand. |
Who may qualify
- Ages
- 18 months to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 200 un-medicated subjects with ADHD and 100 subjects without ADHD will be recruited sequentially. No individual will be excluded based on gender, race, or ethnicity.
Key inclusion criteria (9 listed)
- Signed written informed consent to participate in the study.
- Age: 18 - 55
- If female, non-pregnant, non-nursing with a negative serum pregnancy test and using an adequate form of birth control.
- Supine and standing blood pressure within the range 110/60 to 150/90 mmHg.
- Heart rate, after resting for 5 minutes, within the range 46-90 beats/min.
Key exclusion criteria (14 listed)
- Diagnosis of any psychotic disorder, bipolar disorder, severe depression, severe anxiety, or Autism. Subjects with mild mood, oppositional, conduct, and anxiety disorders may be permitted to participate if considered appropriate by the investigator
- Scores of Baseline Scales:
- Hamilton Depression Scale > 17 (out of a possible 67 on the 21-item scale)(Hamilton 1960) Beck Depression Inventory > 19 (out of a possible 63 on the 21-item scale)(Beck, Ward et al. 1961) Hamilton Anxiety Scale > 21 (out of a possible 56 on the 14-item scale)(Hamilton 1959)
- History of head trauma with loss of consciousness, organic brain disorders, seizures, or neurosurgical intervention.
- Any clinically significant chronic medical condition, in the judgement of the investigator.
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 |
|---|---|---|
| PET imaging using C-11 altropane as the ligand.A one-injection protocol will be used for the study. C-11 Altropane will be injected manually as an intravenous bolus. | Radiation | subjects without ADHD, un-medicated subjects with ADHD |
Primary outcome
The DAT receptor occupancy of OROS MPH and Metadate CD in adults with and without ADHD using PET scanning with C-11 Altropane.
Time frame: Subjects will lie still in the PET camera for a 90 minute period.
PET imaging will be acquired using either a HR+ or Siemens Biograph 64 PET/CT camera.
2 secondary outcomes
Neuropsychological tests
Time frame: Examination of cognitive-neuropsychological functioning will take approximately 2.5 hours to complete.
Genotyping
Time frame: A sample of blood (2 tablespoons) will be drawn from all subjects.
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 28 Jun 2011.
- Derived from this study: PubMed 23273726Spencer TJ, Biederman J, Faraone SV, Madras BK, Bonab AA, Dougherty DD, Batchelder H, Clarke A, Fischman AJ. Functional genomics of attention-deficit/hyperactivity disorder (ADHD) risk alleles on dopamine transporter binding in ADHD and healthy control subjects. Biol Psychiatry. 2013 Jul 15;74(2):84-9. doi: 10.1016/j.biopsych.2012.11.010. Epub 2012 Dec 27.
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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.
Thomas Spencer, MD principal investigator
Massachusetts General Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Hyperactivity Disorder, run by Massachusetts General Hospital.
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 9 inclusion and 14 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 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
The DAT receptor occupancy of OROS MPH and Metadate CD in adults with and without ADHD using PET scanning with C-11 Altropane. (time frame: Subjects will lie still in the PET camera for a 90 minute period.). 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 NCT00302380, which also lists 1 linked publication.
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 28 Jun 2011.