Phase 4
Completed N=168
Treatment of Severe Childhood Aggression (The TOSCA Study)
Attention Deficit Disorder With Hyperactivity
Source: ClinicalTrials.gov NCT00796302 ↗
Enrolled (actual)
168
Serious AEs
0.0%
Results posted
Apr 2016
Primary outcomePrimary: NCBRF-TIQ D-Total Score — 43.5; 42.1; 24.9; 25.9 units on a scale
◆ Published Evidence
Highly cited
140citations · ~12 / year
What does risperidone add to parent training and stimulant for severe aggression in child attention-deficit/hyperactivity disorder?
Summary
This study will determine the safety and effectiveness of two medications for treating aggression in children with attention deficit hyperactivity disorder (ADHD).
Linked Publications (5)
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What does risperidone add to parent training and stimulant for severe aggression in child attention-deficit/hyperactivity disorder?
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Comorbid symptomatology moderates response to risperidone, stimulant, and parent training in children with severe aggression, disruptive behavior disorder, and attention-deficit/hyperactivity disorder.
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Comorbid anxiety and social avoidance in treatment of severe childhood aggression: response to adding risperidone to stimulant and parent training; mediation of disruptive symptom response.
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Factor Validity of a Proactive and Reactive Aggression Rating Scale.
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Participant satisfaction in a study of stimulant, parent training, and risperidone in children with severe physical aggression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY NCBRF-TIQ D-Total Score |
43.5; 42.1; 24.9; 25.9; 22.4; 17.1 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00796302) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.