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

NCT00302380 | Completed DMC

• 1 other identifier: 2000-p-001975
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• 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.

  Subjects will lie still in the PET camera for a 90 minute period.

Secondary Outcomes (2)

• Neuropsychological tests

  Examination of cognitive-neuropsychological functioning will take approximately 2.5 hours to complete.

• Genotyping

  A sample of blood (2 tablespoons) will be drawn from all subjects.

Study Arms (2)

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.

Interventions

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.

subjects without ADHD; un-medicated subjects with ADHD

Eligibility Criteria

• Age: 18 Months - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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
• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Mental Health (NIMH): collaborator

Related Publications (1)

• 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.

  PMID: 23273726 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

A sample of blood (2 tablespoons) will be drawn from all subjects.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Thomas Spencer, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 10, 2006
• First Posted: March 14, 2006
• Study Start: October 1, 2000
• Primary Completion: March 1, 2006
• Study Completion: March 1, 2006
• Last Updated: June 28, 2011

Record last verified: 2011-06