Methylphenidate for Treating Children With ADHD and Tourette Syndrome
Methylphenidate Treatment of ADHD in Children With Tourette Syndrome
2 other identifiers
interventional
71
0 countries
N/A
Brief Summary
This study will evaluate the safety and effectiveness of methylphenidate in treating attention deficit hyperactivity disorder in children with both attention deficit hyperactivity disorder and Tourette syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2000
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 28, 2007
CompletedFirst Posted
Study publicly available on registry
March 1, 2007
CompletedOctober 31, 2013
October 1, 2013
4.3 years
February 28, 2007
October 29, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
ADHD symptoms
Oppositional and aggressive behavior
Frequency and severity of tics and obsessive compulsive disorder symptoms
Tic impairment, tic severity, and clinical response
Anxiety and mood symptoms
Rebound tic exacerbation
Adverse drug reactions (all measured at 2-week intervals throughout the study)
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosis of ADHD or ADHD plus Tourette syndrome
You may not qualify if:
- Determined to be dangerous to self or others
- Scores less than 70 on an IQ test
- Any seizure disorder, major organic brain dysfunction, major medical illness, major mood disorder, psychosis, pervasive developmental disorder, or peripheral sensory loss
- Any condition that may make use of methylphenidate unsafe
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stony Brook Universitylead
- National Institute of Mental Health (NIMH)collaborator
Related Publications (2)
Gadow KD, Sverd J, Sprafkin J, Nolan EE, Ezor SN. Efficacy of methylphenidate for attention-deficit hyperactivity disorder in children with tic disorder. Arch Gen Psychiatry. 1995 Jun;52(6):444-55. doi: 10.1001/archpsyc.1995.03950180030005.
PMID: 7771914BACKGROUNDGadow KD, Sverd J, Sprafkin J, Nolan EE, Grossman S. Long-term methylphenidate therapy in children with comorbid attention-deficit hyperactivity disorder and chronic multiple tic disorder. Arch Gen Psychiatry. 1999 Apr;56(4):330-6. doi: 10.1001/archpsyc.56.4.330.
PMID: 10197827BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kenneth D. Gadow, PhD
State University of New York at Stony Brook
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 28, 2007
First Posted
March 1, 2007
Study Start
February 1, 2000
Primary Completion
June 1, 2004
Study Completion
January 1, 2007
Last Updated
October 31, 2013
Record last verified: 2013-10