A randomized double-blind, placebo-controlled study of risperidone in the treatment of DSM-IV-TR conduct disorder in children and adolescents.
- Conditions
- anti social behavior disorderaggressive behavior among chilren and adolescents with externalizing behavior problems.10037173
- Registration Number
- NL-OMON38186
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 38
Patients are eligible to be included in the study only if they meet all of the inclusion criteria below. ;- Male or female patients aged 5.0 - <17 years and 9 months at Visit 1.;- Patients must have an IQ of > 85
- Patients must meet DSM-IV-TR diagnostic criteria for DSM-IV-TR Conduct Disorder(s) as confirmed by the Kiddie-SADS, Conduct Disorder Module: 312.8x. (Kaufman et al., 1996)
- Patients must score >= 27 on the Nisonger CBR Form, ODD/CD Disruptive Behavior Composite (D-Total)
- Patients must score >=4 (*moderately ill* (or >5, *markedly ill*) on the CGI-S rating scale
- If a female of child-bearing potential, patients must test negative for pregnancy at the time of enrollment based on a serum pregnancy test and agree to use a reliable method of birth control.
- Patients must have a body weight of at least 25 kg at study entry.
- Patients must be able to swallow study drug.
- Patients must have venous access sufficient to allow blood sampling and are compliant with blood draws as per protocol
- Patients meeting criteria for comorbid ADHD (as to the clinical judgment of the investigator) will not be excluded from study participation.
A patient will be excluded from the study if he or she meets any exclusion criteria described below, according to the assessment of the investigator.;- Has been treated with a drug within 14 days before Visit 1 that has not received regulatory approval for any indication at the time of study entry.
- Has participated in any investigational drug trial within six months prior to baseline (visit 3).
- Has previously completed or withdrawn from this study or any other study investigating risperidone or has previously been identified as being a nonresponder or intolerant of risperidone.
- Has a current (within 6 months of the start of the study) or lifetime DSM-IV-TR diagnosis of schizophrenia-related disorders, schizophrenia, bipolar disorder, major depressive disorder, pervasive developmental disorder (autistic disorder or Asperger disorder).
- In the clinical judgment of the investigator, meets criteria for a primary psychiatric disorder, e.g., Anxiety Disorder, Depressive Disorder, Tic Disorder or Tourette*s Syndrome
- Starts any psychotropic medication, including health-food supplements that the investigator feels could have central nervous system activity (for example, St. John*s Wort, melatonin), during the course of the study, or is taking any other excluded concomitant medication(s) at/beyond Visit 2. (An ongoing long-term medication, e.g., to treat a comorbid disorder such as ADHD, is permitted as long as compound and dose are not changed throughout the course of the study.)
- Has any acute or unstable medical condition, physiological condition, clinically significant laboratory, or ECG results that, in the opinion of the investigator, would compromise participation in the study.
- Has a known or suspected seizure disorder.
- Has a history of neuroleptic malignant syndrome (NMS) or of tardive dyskinesia.
- Has a history of hypersensitivity to neuroleptics, of tardive dyskinesia, or neuroleptic malignant syndrome.
- Is pregnant or nursing.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy measurement for the study is the LOCF mean change from<br /><br>baseline to endpoint of the double-blind phase on the Nisonger Child Behavior<br /><br>Rating Form for Typical IQ children-ODD/CD disruptive behavior (DBD) Total<br /><br>Composite score (Lecavalier at al., 2004, Aman et al., 2008) using<br /><br>investigator-ratings based on all available information.<br /><br></p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary efficacy measures will be collected at the visits shown in the Study<br /><br>Schedule of Events (SOE). The measures of efficacy, functional outcome, and<br /><br>cognition that will be administered in this study are briefly described below:<br /><br><br /><br>1) ODD and CD subscores, various<br /><br>- Both ODD and CD scores from Nisonger CBRF -TIQ, separately<br /><br>- Modified Overt Aggression Scale (M-OAS) and subscores<br /><br>2) Clinical Global Impression-Severity (CGI-S)<br /><br>3) Clinical Global Impressions-Improvement (CGI-I)<br /><br>4) Children*s Global Assessment (C-GAS)<br /><br>5) ADHD- DSM-IV Rating Scale (ADHD-RS IV)<br /><br>6) Cognition - computer tasks<br /><br>7) The Child Behavior Checklist (CBCL)<br /><br>8) The Child Health and Illness Profile (CHIP-CE) Parent Report Form<br /><br><br /><br>Physical status<br /><br>Weight<br /><br>Heigth<br /><br>Physical examination<br /><br>Cardiac examination<br /><br>Blood and urine examination</p><br>