HomeAbout PERSConduct DisorderThe PERS studyPatients and relativesResources
Members
The PERS study Work packages WP03

WP03: Long term efficacy study in children and adolescents with CD and a maintained response: a double-blind discontinuation trial

Leader: UNICA / A Zuddas, C Arango

Primary objective

To test the hypothesis that risperidone given orally in a dose of 0.02-0.06 mg/kd/d risperidone is superior to placebo in preventing relapses of disruptive behaviours associated with CD of in- and outpatient children and adolescents not developmentally delayed/mentally retarded, who showed a positive response to risperidone in the short-term double blind trial (12 weeks) followed by 16 weeks open label adminitration.

Secondary objectives

To investigate the effects of long-term effects (40 weeks) of risperidone on

  1. reduction of CD symptoms.
  2. functional outcomes/quality of life.
  3. various behavioural domains.
  4. cognitive functioning.
  5. comorbid ADHD symptoms.
  6. safety and tolerability (AEs, EPS, vital signs, labs, suicidality).

Tertiary objectives

To examine the effect of moderating and mediating factors of the response to risperidone in reducing symptoms of CD.

Top