Treatment of Severe Childhood Aggression (The TOSCA Study)

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michael Aman
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Methylphenidate; Risperidone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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