Treatment of Severe Childhood Aggression (The TOSCA Study) (NCT00796302) | Clinical Trial Compass
CompletedPhase 4
Treatment of Severe Childhood Aggression (The TOSCA Study)
United States168 participantsStarted 2008-08
Plain-language summary
This study will determine the safety and effectiveness of two medications for treating aggression in children with attention deficit hyperactivity disorder (ADHD).
Who can participate
Age range6 Years – 12 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
NCBRF-TIQ D-Total Score
Timeframe: Measured at baseline and Weeks 3, 4, 5, 6, 7, 8, 9