Treatment of Severe Childhood Aggression (The TOSCA Study)

Completed · Phase 4 · Has a placebo group

Conditions studied: Attention Deficit Disorder With Hyperactivity

In brief

This study will determine the safety and effectiveness of two medications for treating aggression in children with attention deficit hyperactivity disorder (ADHD).

Key facts

Study ID

NCT00796302

Run by

Michael Aman

People needed

168

Starts

2008-08-01

Expected to finish

2012-11-01

Last updated by the study team

2017-07-26

Who can join

Age: 6 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• State University of New York Stony Brook — Stony Brook, New York, United States
• Case Western Reserve University — Cleveland, Ohio, United States
• Ohio State University Nisonger Center — Columbus, Ohio, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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