Relapse prevention in children and adolescents with aggressive, antisocial behaviour treated with risperidone.

• Conditions: Conduct disorder DSM-IV-TR; 312.8x; American Psychiatric Association 2000.; MedDRA version: 16.0Level: PTClassification code 10064478Term: Conduct disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]

• Registration Number: EUCTR2010-021884-34-DE
• Lead Sponsor: Radboud University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-09
• Last Update Posted: 13 May 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Patients are only eligible for inclusion in the Dis-CONCA study if they meet all of the following inclusion criteria:
1. male or female aged 5.0 years to 17.5 years at Visit 1
2. a DSM-IV-TR diagnosis of conduct disorder, as confirmed by Kiddie-SADS, Conduct Disorder Module (Kaufman et al., 1996)
3. an IQ of at least 85, measured using 4 subtests (2 verbal, 2 performance) from the Weschler scales, assessed within 2 years of study entry using age and country-specific adaptations (cf Crawford et al., 2010)
4. a minimum score of 27 on the Nisonger Chid Behaviour Rating Form Typical IQ ODD/CD Disruptive Behaviour Composite (D-Total) at baseline (Visit 1 or 2)
5. a minimum score of 4 (moderately ill or markedly ill) on the Clinical Global Impressions-Severity scale at both baseline visits (1 and 2)
6. a body mass index that lies between the 5th and 95th percentiles of the WHO age and sex specific charts
7. must be able to swallow the study drug
8. must have sufficient venous access to allow blood sampling and be compliant with the blood-draws stated in the protocol
9. for female patients of child-bearing potential, the urine pregnancy test at the time of enrollment must be neagtive, and she must agree to use a reliable form of contraception. Adequate contraception includes oral contraceptives, intrauterine devices, double barrier methods (diaphragm or condom plus spermicide), and Norpant or depot Provera
10. laboratory results, including serum chemistry, haematology, and urinalysis, must show no significant abnormalites (significant would include deviations requiring acute medical intervention or further medical evaluation) and there is no clinical information that would, in the opinion of the investigator, preclude participation
11. all patients must have an ECG at Visit 1 or 2. Results must be available before the drug is dispensed 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. educational level and degree of understanding of the patient and the parents (or legal gaurdians) must be adequate to allow appropraite communication with the investigator and study coordinator
13. subject's parents/legal guardians must provide written informed consent; patients must provide informed consent and sign the assent forms is capable, in accordance with local legal requirements.
14. a reliable person (primary caregiver, parent) must be available to ensure compliance with study procedures throughout the course of the study
15. patients meeting the criteria for comorbid ADHD (according to the clinical judgement of the investigator) will not be excluded from participation.

Are the trial subjects under 18? yes
Number of subjects for this age range: 80
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 any of the following criteria are met:
1. an immediate family member of the patient is professionally affiliated to the investigator site. Immediate family is defined as spouse, parent, child, or sibling, whether biological or adopted
2. has previously participated in or withdrawn from this study or has been identified as a non-responder to- or intolerant of risperidone
3. has been treated within 14 days of 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 in the six months prior to baseline
4. has a current (within 6 months of the start of the study) or a lifetime DSM-IV-TR diagnosis of schizophrenia-related disorder, schizophrenia, bipolar disorder, major depressive disorder, or a current subtance dependence disorder( given the nature of the study population, substance missue or abuse is not exclusionary), pervasive developmental disorder (autism, Asperger's)
5. currently meets (in the opinion of the investigator) the criteria for a primary psychiatric diagnosis, e.g. an anxiety disorder, depression, Tic disorder, Tourette's syndrome
6. starts any psychotropic medication, including health food supplements, that the investigator feels could have central nervous system effects (e.g. St John's Wort, melatonin) during the course of the study, or is taking any other excluded concomitant medication (specified in section 5.7 of the study protocol). An ongoing long-term medication is permitted as long as the compound and the dose remain unchanged throughout the study, e.g. medication for comorbid ADHD
7. has a history of hypersensitivity to neuroleptics, or a history of tardive dyskinesia or malignant neuroleptic syndrome
8. has a known or suspected seizure disorder
9. female patients who are pregnant or nursing
10. patients with a history of severe allergy to more than one class of medications or multiple adverse drug reactions.

Study & Design

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