A PET Study Examining Pharmacokinetics and Dopamine Transporter Receptor Occupancy Of Two Long-Acting Formulations of Methylphenidate in Adults
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|ClinicalTrials.gov Identifier: NCT00301639|
Recruitment Status : Completed
First Posted : March 13, 2006
Last Update Posted : July 12, 2011
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|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Drug: OROS methylphenidate hydrochloride Drug: methylphenidate hydrochloride||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||A PET Study Examining Pharmacokinetics and Dopamine Transporter Receptor Occupancy Of Two Long-Acting Formulations of Methylphenidate in Adults|
|Study Start Date :||March 2005|
|Actual Primary Completion Date :||December 2005|
|Study Completion Date :||December 2005|
- The DAT receptor occupancy of OROS MPH and Metadate CD using PET scanning with C-11 Altropane. Objective measures also provided by d and l ritalinic acid and methylphenidate levels at pre-dose, hr 9, 10 and 11.
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|Ages Eligible for Study:||18 Years to 55 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Signed written informed consent to participate in the study.
- Age: 18 - 55
- If female, non-pregnant, non-nursing, using an adequate form of birth control or a negative serum pregnancy test.
- 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 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 et al 1961) Hamilton Anxiety Scale > 21 (out of a possible 56 on the 14-item scale) (Hamilton 1959)
- Tics or Tourette's Syndrome.
- Diagnosis of ADHD
- History of head trauma with loss of consciousness, organic brain disorders, seizures, or neurosurgical intervention.
- Any clinically significant chronic medical condition, in the judgment of the investigator.
- Mental impairment as evidenced by an I.Q. <75.
- Exposure to dopamine receptor antagonists within the previous three (3) months.
- 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.
- Subjects diagnosed with glaucoma.
- Subjects at risk for MPH toxicity (e.g. individuals with arrhythmias, coronary artery disease, etc.).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00301639
|United States, Massachusetts|
|Massachusetts General Hospital|
|Cambridge, Massachusetts, United States, 02138|
|Principal Investigator:||Thomas Spencer, MD||Massachusetts General Hospital|
|Responsible Party:||Thomas J. Spencer, MD, Massachusetts General Hospital|
|Other Study ID Numbers:||
|First Posted:||March 13, 2006 Key Record Dates|
|Last Update Posted:||July 12, 2011|
|Last Verified:||July 2011|
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action