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Trial record 72 of 439 for:    Methylphenidate

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

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ClinicalTrials.gov Identifier: NCT00593112
Recruitment Status : Completed
First Posted : January 14, 2008
Results First Posted : May 5, 2011
Last Update Posted : August 31, 2012
Sponsor:
Information provided by (Responsible Party):
Paul Hammerness, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition ADHD
Interventions Drug: OROS methylphenidate
Other: No intervention
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title OROS Methylphenidate Control
Hide Arm/Group Description OROS = Osmotic-controlled Release Oral delivery System Healthy Volunteer Control group
Period Title: Overall Study
Started 27 12
Completed 17 12
Not Completed 10 0
Reason Not Completed
Scan Anxiety             3             0
Abnormal Scan             1             0
Unreadable Scan             1             0
Withdrawal by Subject             5             0
Arm/Group Title OROS Methylphenidate Control Total
Hide Arm/Group Description OROS = Osmotic-controlled Release Oral delivery System Healthy Volunteer Control group Total of all reporting groups
Overall Number of Baseline Participants 27 12 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 12 participants 39 participants
<=18 years
27
 100.0%
12
 100.0%
39
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 12 participants 39 participants
Female
9
  33.3%
5
  41.7%
14
  35.9%
Male
18
  66.7%
7
  58.3%
25
  64.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 12 participants 39 participants
27 12 39
1.Primary Outcome
Title Proton Magnetic Resonance Spectroscopy (H MRS) Scan Results - Glutamate(Glu)/Myo-inositol-containing Compounds (Ino)
Hide Description

Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)

This measure is a ratio of Glutamate (excitatory neurotransmitter) to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate.

Time Frame after 6 weeks Concerta treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Seven subjects who completed the protocol were not included due to a lack of baseline comparison.
Arm/Group Title OROS Methylphenidate Control
Hide Arm/Group Description:
OROS = Osmotic-controlled Release Oral delivery System
Healthy Volunteer Control group
Overall Number of Participants Analyzed 10 12
Mean (Standard Deviation)
Unit of Measure: MRS Ratio
1.50  (0.45) 1.56  (0.34)
2.Primary Outcome
Title H MRS Scan Results - Glutamine (Gln)/Ino
Hide Description

Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)

This measure is a ratio of Glutamine (amino acid precursor to Glu) to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate.

Time Frame after 6 weeks Concerta treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Seven subjects who completed the protocol were not included due to a lack of baseline comparison.
Arm/Group Title OROS Methylphenidate Control
Hide Arm/Group Description:
OROS = Osmotic-controlled Release Oral delivery System
Healthy Volunteer Control group
Overall Number of Participants Analyzed 10 12
Mean (Standard Deviation)
Unit of Measure: MRS Ratios
1.08  (0.43) 1.02  (0.60)
3.Primary Outcome
Title H MRS Scan Results - Glutamate & Glutamine (Glx)/Ino
Hide Description

Comparison of treated ADHD participants (6 weeks on Concerta) and Healthy Control Subjects (HCS)

This measure is a ratio of Glutamate and it's precursor, Glutamine, to myo-inositol (cyclic sugar alcohol) containing compounds in the anterior cingulate.

Time Frame after 6 weeks Concerta treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Seven subjects who completed the protocol were not included due to a lack of baseline comparison.
Arm/Group Title OROS Methylphenidate Control
Hide Arm/Group Description:
OROS = Osmotic-controlled Release Oral delivery System
Healthy Volunteer Control group
Overall Number of Participants Analyzed 10 12
Mean (Standard Deviation)
Unit of Measure: MRS Ratio
2.58  (0.73) 2.59  (0.87)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title OROS Methylphenidate Control
Hide Arm/Group Description OROS = Osmotic-controlled Release Oral delivery System Healthy Volunteer Control group
All-Cause Mortality
OROS Methylphenidate Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
OROS Methylphenidate Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
OROS Methylphenidate Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)   0/12 (0.00%) 
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Paul Hammerness, M.D.
Organization: Massachusetts General Hospital
Phone: 617-503-1040
EMail: phammerness@partners.org
Layout table for additonal information
Responsible Party: Paul Hammerness, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00593112     History of Changes
Other Study ID Numbers: 2005-P-002180
First Submitted: December 28, 2007
First Posted: January 14, 2008
Results First Submitted: January 7, 2011
Results First Posted: May 5, 2011
Last Update Posted: August 31, 2012