A study to assess the safety and effectiveness of the antipsychotic medication risperidone in the treatment of children and adolescents with the psychiatric diagnosis conduct disorder - which is characterised by persistent aggressive and antisocial behaviour - by comparing it to treatment with a non-active substance. Patients will be randomly allocated to treatment with the active- or the non-active substance.

• Conditions: Conduct Disorder (DSM-IV-TR; 312.8x; American Psychiatric Association); MedDRA version: 16.0Level: PTClassification code 10064478Term: Conduct disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2011-000567-26-DE
• Lead Sponsor: Radboud University Medical Centre Nijmegen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-17
• Last Update Posted: 13 May 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

Patient will only be eligible for inclusion in the acute CONCA study if they fulfil all of the following inclusion criteria:-
1. male or female aged 5.0-17.9 years at Visit 1
2. intelligence quotient of >85 (based on 4 subtests of the Weschler intelligence scales- vocabulary, matrix reasoning, block design, and similarities; compare with Crawford et al., 2010)
3. a DSM-IV-TR diagnosis of conduct disorder, as confirmed by the Kiddies-SADS Conduct Disorder Module: 312.8x (Kaufman et al., 1996), at Visit 2 and Visit 3
4. a minimum score of 27 on the Nisonger CBRF ODD/CD disruptive Behaviour Composite (D-Total) at either Visit 2 or Visit 3
5. a minimum score of 4 (moderately ill; or >5 markedly ill) on the Clinical Global Impression- Severity scale at Visit 2 and Visit 3
6. in female patients of child-bearing potential, the serum pregnancy test at the time of enrollment must be negative; and these patients must agree to use a reliable method of contraception (i.e. oral contraceptives; intrauterine devices; double-barrier methods - diaphragm or condom with spermicide; Norplant or depot Provera)
7. a body weight of at least 20kg at study entry
8. patients must be able to swallow the study tablets
9. patients must have sufficient venous access to allow blood sampling and be compliant with blood sampling as stated in the protocol
10. the subject's parents/legal guardians must provide written informed consent; patients must provide informed consent and sign the consent/assent documents if capable, in accordance with the legal requirements of the respective country
11. a reliable person (primary caregiver, parent) must be available throughout the course of the study to ensure compliance with the study procedures
12. patients meeting the criteria for comorbid ADHD (according to the clinical judgement of the investigator) will not be excluded from study participation.
Are the trial subjects under 18? yes
Number of subjects for this age range: 88
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A patient will be excluded from the study if he/she meets any of the following exclusion criteria:-
1. is a member of the immediate family of any investigator site personnel directly affiliated with the study. Immediate family is defined as spouse, parent, child, or sibling, whether biological or adopted
2. has been treated within the 14 day period prior to Visit 1 with a drug that has not received regulatory approval for any indication at the time of study entry
3. has participated in any investigational drug trial within the six month period prior to baseline (Visit 3)
4. has previously completed or withdrawn from this study, or has previously been identified as a non-responder to or intolerant of risperidone
5. has a current (i.e. within 6 months of the start of the study) or lifetime DSM-IV-TR diagnosis of a schizophrenia-related disorder; schizophrenia; bipolar disorder; major depression; current substance dependence disorder (given the nature of the study population, substance missue or -abuse is not exclusionary); or pervasive developmental disorder (autistic disorder or Asperger disorder)
6. in the clinical judgement of the investigator, the patient meets the criteria for a primary psychiatric disorder, e.g. an anxiety disorder, depressive disorder, Tic disorder, or Tourette Syndrome (comorbid ADHD is permitted, see inclusion criteria)
7. the patient starts any psychotropic medication during the course of the study, including health-food supplements, that may, in the opinion of the investigator, affect central nervous system activity, or is taking any other excluded medication at or beyond Visit 2 (specified in Section 5.7 of the study protocol). A long-term medication - e.g. to treat a comorbid disorder such as ADHD - is permitted as long as the compound and the dose remain unchanged throughout the course of the study
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 study participation
9. has a known or suspected seizure disorder
10. has a history of neuroleptic malignant syndrome or tardive dyskinesia
11. has a history of hypersensitivity to neuroleptics
12. is pregnant or nursing.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified