Proton Magnetic Spectroscopy in Children and Adolescents With ADHD Before and After Treatment With OROS Methylphenidate

This study has been completed.

Study NCT00593112 Information provided by Massachusetts General Hospital

First Received on December 28, 2007. Last Updated on May 4, 2011 History of Changes

Results First Received: January 7, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: Open Label
Condition:	ADHD
Interventions:	Drug: OROS methylphenidate Other: No intervention

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
OROS Methylphenidate	OROS = Osmotic-controlled Release Oral delivery System
Control	Healthy Volunteer Control group

Participant Flow: Overall Study

	OROS Methylphenidate	Control
STARTED	27	12
COMPLETED	17	12
NOT COMPLETED	10	0
Scan Anxiety	3	0
Abnormal Scan	1	0
Unreadable Scan	1	0
Withdrawal by Subject	5	0

Baseline Characteristics

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Reporting Groups

	Description
OROS Methylphenidate	OROS = Osmotic-controlled Release Oral delivery System
Control	Healthy Volunteer Control group

Baseline Measures

	OROS Methylphenidate	Control	Total
Number of Participants [units: participants]	27	12	39
Age [units: participants]
<=18 years	27	12	39
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Gender [units: participants]
Female	9	5	14
Male	18	7	25
Region of Enrollment [units: participants]
United States	27	12	39

Outcome Measures

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1. Primary:

Proton Magnetic Resonance Spectroscopy (H MRS) Scan Results - Glutamate(Glu)/Myo-inositol-containing Compounds (Ino) [ Time Frame: after 6 weeks Concerta treatment ]

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2. Primary:

H MRS Scan Results - Glutamine (Gln)/Ino [ Time Frame: after 6 weeks Concerta treatment ]

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3. Primary:

H MRS Scan Results - Glutamate & Glutamine (Glx)/Ino [ Time Frame: after 6 weeks Concerta treatment ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Paul Hammerness, M.D.
Organization: Massachusetts General Hospital
phone: 617-503-1040
e-mail: phammerness@partners.org

No publications provided

Responsible Party:	Paul Hammerness, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:	NCT00593112 History of Changes
Other Study ID Numbers:	2005-P-002180
Study First Received:	December 28, 2007
Results First Received:	January 7, 2011
Last Updated:	May 4, 2011
Health Authority:	United States: Institutional Review Board