CONCA

• Research type

  Research Study

• Full title

  A randomized double-blind, placebo-controlled study of risperidone in the treatment of DSM-IV-TR conduct disorder in children and adolescents.

• IRAS ID

  105425

• Contact name

  David Coghill

• Sponsor organisation

  Radboud University Medical Centre Nijmegen

• Eudract number

  2011-000567-26

• Research summary

  Risperidone is frequently used off label to treat conduct disorder in children and adolescents. CONCA is a multicentre, randomized, double-blind, parallel, placebo-controlled trial designed to assess the short term efficacy; safety and tolerability of risperidone in children and adolescents with conduct disorder. The primary objective is to investigate whether risperidone given orally in a dose of 0.02-0.06 mg/kg/day for 12 weeks is superior to placebo in reducing symptoms of Conduct Disorder (CD) in the treatment of in- and outpatient children and adolescents with normal IQ. This trial will be part of a series of studies that have been prioritized by the Paediatric Committee of the European Medicines Agency (EMA) in order to obtain a Paediatric Marketing Authorization (PUMA) for the use of risperidone in this group of children and adolescents. The secondary objectives are to investigate the effects of risperidone compared to placebo on; response rate, functional outcomes/quality of life, various behavioural domains, cognitive functioning, comorbid ADHD symptoms, safety and tolerability (adverse effects, vital signs, laboratory measures and suicidality. The study will be conducted in three phases; Study Period I will be a 2 week screening (and washout) period; Study Period II will be a 12-week double-blind, randomized, placebo-controlled period, and Study Period III will be a double-blind 1 week down-titration period. 264 subjects (50% children, 50% adolescents) will be randomized with a 1:1 randomization to Risperidone and placebo into study period II and all patients who complete Study Period II will participate in Study Period III. The study will be conducted at 14 sites across Europe (Netherlands, Germany, UK, France, Spain, Italy, Belgium). The UK will contribute around 60 subjects split evenly across two sites.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  13/ES/0007

• Date of REC Opinion

  6 Feb 2013

• REC opinion

  Further Information Favourable Opinion