Status:
COMPLETED
Treatment of Severe Childhood Aggression (The TOSCA Study)
Lead Sponsor:
Michael Aman
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Attention Deficit Disorder With Hyperactivity
Eligibility:
All Genders
6-12 years
Phase:
PHASE4
Brief Summary
This study will determine the safety and effectiveness of two medications for treating aggression in children with attention deficit hyperactivity disorder (ADHD).
Detailed Description
ADHD is characterized by inattention, impulsivity, and hyperactivity. Children with ADHD sometimes also have disruptive behavior disorders (DBDs), such as conduct disorder (CD), which is estimated to ...
Eligibility Criteria
Inclusion
- DSM-IV diagnosis of ADHD, any subtype
- DSM-IV diagnosis of a disruptive behavior disorder, including CD or ODD
- Evidence of serious physical aggression, as rated on the Overt Aggression Scale-Modified, and as determined by parent or guardian ratings on the NCBRF D-Total Score. In addition, the blinded clinician must assign a clinical global impressions severity score of 4 or greater for aggression.
- Prior to random assignment, participants must be free of all psychotropic medicines for 2 weeks for most drugs (such as most antidepressants, alpha agonists, beta blockers, anxiolytics, mood stabilizers, and antihistamines), and 4 weeks for depot antipsychotics and fluoxetine.
Exclusion
- Full-scale IQ below 71
- Pregnancy or a history of seizure disorder or other neurological or medical disorders for which medication may present a considerable risk
- Abnormal liver function
- Pervasive developmental disorder, schizophrenia or other psychotic disorders, or eating disorders
- Currently taking other psychotropic medications from which discontinuation would present a significant risk. Participants may not discontinue a satisfactory medication to participate.
- Presence or history of major depressive disorder
- Diagnosis of bipolar disorder
- A hypomanic/biphasic score of 36 or greater as rated by child's parent on the General Behavior Inventory and confirmed by clinician as indication of mood disorder
- Active substance abuse disorder or lack of control of substance use that does not allow for safe medication administration
- Evidence of current child abuse or neglect
- History of suicide attempt in the past year or current suicidal ideation with plan and/or intent
- Family history of type II diabetes in two or more first degree relatives, defined as biological parents and/or full biological siblings
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT00796302
Start Date
August 1 2008
End Date
November 1 2012
Last Update
July 26 2017
Active Locations (4)
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1
State University of New York Stony Brook
Stony Brook, New York, United States, 11794
2
Case Western Reserve University
Cleveland, Ohio, United States, 44106
3
Ohio State University Nisonger Center
Columbus, Ohio, United States, 43210
4
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213