Conduct Disorder DSM-IV-TR
Conditions
Interventions
Trade Name: Risperidone
Product Name: Risperidone
Product Code: 6000803
Pharmaceutical Form: Tablet
INN or Proposed INN: Risperidone
CAS Number: 106266-06-2
Current Sponsor code: CHMP/384877/2008
Othe
Sponsors
Radboud University Medical Centre Nijmegen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients are eligible to be included in the study only if they meet all of the inclusion criteria below. [1] Patients (male or female) must be at least 5 years of age, and not more than 17 years and 5 months of age at Visit 1. [2] Patients must meet DSM-IV-TR diagnostic criteria for DSM-IV CD (312.xx) as confirmed by the Kiddie-SADS, Conduct Disorder Module (Kaufman et al., 1996). [3] Patients must have an IQ of > 85, measured by 4 subtests (2 verbal plus 2 performance tests) from the Wechsler IQ Scales, (e.g. WISC; WAIS; assessed within =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A patient will be excluded from the study if he or she meets any exclusion criterion described below. [1] An immediate family member of the patient is professionally affiliated to the investigator site. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. [2] Has previously completed or withdrawn from this study or has been previously identified as being a non-responder or intolerant of risperidone. [3] Has been treated within 14 days before Visit 1 with a drug that has not received regulatory approval for any indication at the time of study entry, or has participated in any investigational drug trial within six months prior to baseline (visit 1). [4] Has a current (within 6 months of the start of the study) or lifetime DSM-IV diagnosis of schizophrenia-related disorders, schizophrenia, bipolar disorder, major depressive disorder or a current substance dependence disorder (given the nature of the study population substance misuse or abuse is not exlusionary), pervasive developmental disorder (autistic disorder or Asperger disorder). [5] In the clinical judgment of the investigator, currently meets criteria for a primary psychiatric disorder, e.g., Anxiety Disorder, Depressive Disorder, Tic Disorder or Tourette’s Syndrome (comorbid ADHD is permitted, cf. Incl. criteria section). [6] 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) specified in Section 5.7). (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). [7] Has a history of hypersensitivity to neuroleptics, of tardive dyskinesia, or neuroleptic malignant syndrome. [8] 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. [9] Has a known or suspected seizure disorder. [10] Female patients who are pregnant or breastfeeding. [11] Patients with a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Within four years after start of inclusion first patient;Main Objective: The primary objective is to test the hypothesis that, after at least 16 weeks of daily administration (4 for titration, 12 of relatively stable dose, 4 of which at fixed doses, (Study Period 1), risperidone given orally in a dose of 0.25 – 3.0 mg/d depending on body weight (eq. to approximately 0.01 – 0.04 mg/kg/d) is superior to placebo in preventing relapse of symptoms of CD, as assessed through a 12 week, double-blind discontinuation trial (Study Period 2) of children and adolescents not developmentally delayed/mentally retarded, and measured by comparison with mean change from the double-blind baseline to endpoint on the Nisonger Child Behavior Rating Form (CBRF) - Typical IQ Version-ODD/CD disruptive behavior (DBD) Composite Total score (Aman et al., 2008) using investigator-ratings based on all available information. ;Secondary Objective: To establish the long-term efficacy of treatment with risperidone, measuring mean change from the double-blind baseline to endpoint on the pivotal (Nisonger) scale between risperidone and placebo. To test the effect of risperidone compared to placebo on various behavioural domains following seven months of daily administration of risperidone assessed in a 12-week, double-blind discontinuation trial. To compare changes (impairment) in neurocognitive function following risperidone, assessed in both the 16 weeks open label and the 12-week, double-blind discontinuation trial. To assess the effect of risperidone compared to placebo on comorbid ADHD symptoms following seven months of daily administration of risperidone assessed in a 12-week, double-blind discontinuation trial. To compare safety and tolerability results for risperidone and placebo in children and adolescents with CD over 12 weeks of double-blind treatment. ;Primary end point(s): Clinical response is defined as > 25 % reduction from baseline sc | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary outcome measures focus on assessment of changes with active treatment vs. placebo. - CGI-I and CGI-S (Guy, 1976; NIMH, 1985) - C-GAS (Kaufman, 1996) - ADHD-DSM IV-RS (DuPaul et al., 1998) - OAS-M (Coccaro et al., 1991) - CHIP-CE (Riley et al.2004) - Child Behavior Checklist (CBCL), parent-reported (Achenbach, 1991a) - PAERS (March et al., 2007) - ANT (De Sonneville, 1999) - C-SSRS (Posner et al., 2007b) ;Timepoint(s) of evaluation of this end point: Within four years after start of inclusion first patient | — |
Countries
Germany, Netherlands, Spain
Contacts
Public ContactClinical Trial Information
Radboud University Medical Centre Nijmegen
Outcome results
None listed