Status:
COMPLETED
Study Examining Repeat Dosing of OROS® Methylphenidate (CONCERTA®) and Immediate Release Methylphenidate in Healthy Adults
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
There are two specific aims of this study. The first is to document the pharmacokinetics of dopamine transporter (DAT) receptor occupancy of repeated administration of orally administered, therapeutic...
Detailed Description
ROS-MPH's pharmacokinetic profile uses an increasing delivery of MPH over the day (ascending pharmacokinetic curve). It was designed to replace IR-MPH TID treatment. The main target of MPH in the brai...
Eligibility Criteria
Inclusion
- 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 plasma 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
Exclusion
- Subjects with marked anxiety, tension, and agitation since the drug may aggravate these symptoms
- Subjects with known hypersensitivity to methylphenidate or other components of Concerta or Ritalin
- Subjects with glaucoma
- Subjects with motor tics or with a family history or diagnosis of Tourette's syndrome
- Subjects treated with monoamine oxidase inhibitors (MAOIs) or within 14 days of discontinuation of treatment with MAOIs
- 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)
- Diagnosis of ADHD (attention deficit hyperactivity disorder)
- 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 intelligence quotient (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 (electrocardiogram), 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 :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00302393
Start Date
June 1 2006
End Date
February 1 2008
Last Update
October 22 2013
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114