Relapse prevention in children and adolescents with DSM-IV Conduct Disorder treated with Risperidone: a Randomized Double blind, Placebo-Controlled, Discontinuation Study.

Phase 4

Not yet recruiting

Conditions: Antisocial behavior disorder
aggressive behavior among children and adolescents with externalizing behavior problems
10037173

Registration Number: NL-OMON38142

Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 22

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
[3] Patients must have an IQ of > 85
[4] Patients must score >= 27 on the Nisonger CBR Form, ODD/CD Disruptive Behavior Composite (D-Total) at baseline
[5] Patients must score >= 4 (*moderately ill* or *markedly ill*) on the CGI-S rating scale at both baseline measures
[6] Patients must have a body weight comprised between 5th and 95th percentile based on WHO Body Mass Index for age-sex specific charts, at study entry.
[7] Patients must be able to swallow the study drug.
[8] Patients must have venous access sufficient to allow blood sampling and are compliant with blood draws as per protocol.
[9] If the patient is a female with child-bearing potential, she must test negative for pregnancy (based on a urine pregnancy test) at the time of enrollment and agree to use a reliable method of birth control.
[10] Laboratory results, including serum chemistries, hematology and urinalysis, show no significant abnormalities (significant would include laboratory deviations requiring acute medical intervention or further medical evaluation) and there is no clinical information that, in the judgment of a physician, should preclude a patient*s participation at study entry.
[11] All patients must have an ECG at Visit 1 or 2. Results must be available prior to dispensing drug at Visit 3. If an ECG shows any severe abnormality, the patient must be excluded from the study. Patients with other abnormalities may be included at the discretion of the investigator.
[12] Patients meeting criteria for comorbid ADHD (as to the clinical judgement of the investigator) will not be excluded from study participation.

Exclusion Criteria

A patient will be excluded from the study if he or she meets any exclusion criterion described below.;- Has previously completed or withdrawn from this study or has been previously identified as being a non-responder or intolerant of risperidone.
- 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).
- 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, pervasive developmental disorder (autistic disorder or Asperger disorder).
- 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).
- 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 protocol. (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 a history of hypersensitivity to neuroleptics, of tardive dyskinesia, or neuroleptic malignant syndrome.
- 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.
- Female patients who are pregnant or breastfeeding.
- Patients with a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Clinical response is defined as > 25 % reduction from baseline score on the<br /><br>Nisonger CBRF-TIQ D-Total subscale at endpoint (based on a personal<br /><br>communication of the scale author, Dr. Michael Aman, June 2010) and a score of<br /><br>1 or 2 (much or very much* improved) on the CGI-Improvement scale. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Relapse rate, with relapse defined a CGI-S rating > 2 points, compared to the<br /><br>prediscontinuation baseline, and a 25% increase in the score on the pivotal<br /><br>Nisonger CBRF-TIQ D-Total scale for at least two consecutive visits, 12-16 days<br /><br>apart (Reyes et al., 2006).</p><br>