Status:
COMPLETED
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
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
18-55 years
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 different...
Detailed Description
This protocol seeks to replicate and extend our investigation of DAT binding in adults with ADHD with specific aims: 1. To examine dopamine transporter (DAT) receptor binding potential in adults with...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2000
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00302380
Start Date
October 1 2000
End Date
March 1 2006
Last Update
June 28 2011
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