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The PERS study Work packages WP02

WP02: Short–term efficacy and safety/tolerability of risperidone in children and adolescents with conduct disorder and normal IQ

Leader: CIMH / R Dittmann

Primary objective

To test the hypothesis that risperidone given orally in a dose of 0.02-0.06 mg/kd/d for 12 weeks is superior to placebo in reducing symptoms of DSM-IV Conduct Disorder (CD) in the treatment of in- and outpatient children and adolescents with normal IQ

Secondary objectives

To investigate the effects of risperidone compared to placebo on

  1. Response rate.
  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.

This trial will be part of a series of studies in order to obtain a Paediatric Marketing Authorization (PUMA) for the use of risperidone in children and adolescents from EMEA.

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