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

NCT00593112 | Completed Phase 4 Results

• 1 other identifier: 2005-P-002180
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This will be an open label study using daily does of up to 126mg/day of Concerta in the treatment of children and adolescents, ages 12-17, who meet DSM-IV criteria for ADHD. Specific hypotheses are as follows: Hypothesis 1: Children and adolescents with ADHD will have significantly higher ACC and DLPFC Glutamate/myo-Inositol containing compounds (Glu/Ino) and Glutamate/creatine + phosphocreatine (Glu/Cr) than matched HCS. Hypothesis 2: After six weeks of treatment, OROS methylphenidate will lower ACC and DLPFC Glu/Ino and Glu/Cr levels in children with ADHD who are methylphenidate responders.

Conditions

ADHD

Keywords

HMRS Scanning; ADHD; Child; Adolescent; HMRS Scans

Outcome Measures

Primary Outcomes (3)

• Proton Magnetic Resonance Spectroscopy (H MRS) Scan Results - Glutamate(Glu)/Myo-inositol-containing Compounds (Ino)

  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.

  after 6 weeks Concerta treatment

• H MRS Scan Results - Glutamine (Gln)/Ino

  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.

  after 6 weeks Concerta treatment

• H MRS Scan Results - Glutamate & Glutamine (Glx)/Ino

  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.

  after 6 weeks Concerta treatment

Study Arms (2)

OROS Methylphenidate

EXPERIMENTAL

Drug: OROS methylphenidate

Control

OTHER

Healthy Volunteer Control group

Other: No intervention

Interventions

OROS methylphenidate DRUG

Concerta is given in capsule form with a minimum dose of 18 mg/day and a max of 126 mg/day. Subjects take Concerta once per day for 6 weeks.

Also known as: Concerta

OROS Methylphenidate

No intervention OTHER

No intervention

Control

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female subjects, 12-17 years of age.
• ADHD subjects must meet study criteria for the "Prevention of Cigarette Smoking in ADHD Youth with CONCERTA Protocol"; #2003-P-001313.
• Control subjects must not meet full DSM-IV criteria for Attention Deficit Hyperactivity Disorder, or any other current major psychiatric disorder.
• Each subject and his/her authorized legal representative must understand the nature of this proposed study, and must sign informed consent and informed assent documents.
• Subject and parent must have a level of understanding sufficient to communicate intelligently with the investigator and study coordinator, and to cooperate with study procedures.

You may not qualify if:

• Clinically significant chronic medical condition including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
• Organic brain disorders or mental retardation (I.Q. \<75).
• Contraindication to MRI including presence of metal or surgical devices (plates, implants, braces or other items).
• Pregnancy; women of child bearing potential must be using a medically approved method of birth control. Women of child bearing potential will receive a urinary pregnancy test prior to each MR scanning session.
• Severe phobia of being in small, enclosed spaces.
• Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild will not be eligible to participate in the treatment arm of the study.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Cambridge, Massachusetts, 02138, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Paul Hammerness, M.D.
• Organization: Massachusetts General Hospital

phammerness@partners.org

617-503-1040

Study Officials

• Paul Hammerness, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator, Clinical and Research Program in Pediatric Psychopharmacology and Adult ADHD

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: January 14, 2008
• Study Start: November 1, 2006
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: August 31, 2012
• Results First Posted: May 5, 2011

Record last verified: 2012-08

Locations

US (1)