Relapse prevention in children and adolescents with DSM-IV Conduct Disorder treated with Risperidone: a Randomized Double blind, Placebo-Controlled, Discontinuation Study. - CONCA-2
- Conditions
- Conduct Disorder DSM-IV-TR312.8x, APA 2000MedDRA version: 14.1Level: PTClassification code 10064478Term: Conduct disorderSystem Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Psychiatry and Psychology [F] - Behavioral Disciplines and Activities [F04]
- Registration Number
- EUCTR2010-021884-34-NL
- Lead Sponsor
- Radboud University Medical Centre Nijmegen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
Patients are eligible to be included in the study only if they meet all of the inclusion criteria below.
[1]Patients (male or female) must be at least 5 years of age, and not more than 17 years and 5 months of age at Visit 1.
[2] Patients must meet DSM-IV-TR diagnostic criteria for DSM-IV CD (312.xx) as confirmed by the Kiddie-SADS, Conduct Disorder Module (Kaufman et al., 1996).
[3]Patients must have an IQ of > 85, measured by 4 subtests (2 verbal plus 2 performance tests) from the Wechsler IQ Scales, (e.g. WISC; WAIS; assessed within < 2 y. before or at study entry), e.g. vocabulary, similarities, block design, and matrix reasoning (cf. Crawford et al., 2010). Age- and country-specific adaptations may be used (detailed instructions may be provided in a respective extra document)
[4]Patients must score = 27 on the Nisonger CBR Form, ODD/CD Disruptive Behavior Composite (D-Total) at baseline (Visit 1 or 2).
[5]Patients must score = 4 (moderately ill” or markedly ill”) on the CGI-S rating scale at both baseline measures (visit 1 and 2).
[6]Patients must have a body weight comprised between 5th and 95th percentile based on WHO Body Mass Index for age-sex specific charts, at study entry.
[7] Patients must be able to swallow the study drug.
[8]Patients must have venous access sufficient to allow blood sampling and are compliant with blood draws as per protocol.
[9]If the patient is a female with child-bearing potential, she must test negative for pregnancy (based on a urine pregnancy test) at the time of enrollment and agree to use a reliable method of birth control. Adequate contraception includes: oral contraceptives, intraueterine devices; double barrier method (diaphragm or condom plus spermicide, Norplant™ or Depot Provera™).
[10]Laboratory results, including serum chemistries, hematology and urinalysis, show no significant abnormalities (significant would include laboratory deviations requiring acute medical intervention or further medical evaluation) and there is no clinical information that, in the judgment of a physician, should preclude a patient’s participation at study entry.
[11]All patients must have an ECG at Visit 1 or 2. Results must be available prior to dispensing drug 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 so that the patients and parents (or legal representative) can communicate suitably with the investigator and study coordinator.
[13] Subjects’ parents/legal guardians must provide and sign informed consent documents; patients must provide informed consent, and sign consent or assent documents if capable, according to the legal requirements in the very country. A reliable person (primary caregiver, parent) must be available to ensure compliance with study procedures throughout the course of the study.
[14] Patients meeting criteria for comorbid ADHD (as 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: 22
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
A patient will be excluded from the study if he or she meets any exclusion criterion described below.
[1]An immediate family member of the patient is professionally affiliated to the investigator site. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
[2]Has previously completed or withdrawn from this study or has been previously identified as being a non-responder or intolerant of risperidone.
[3]Has been treated within 14 days before 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 within six months prior to baseline (visit 1).
[4]Has a current (within 6 months of the start of the study) or lifetime DSM-IV diagnosis of schizophrenia-related disorders, schizophrenia, bipolar disorder, major depressive disorder or a current substance dependence disorder (given the nature of the study population substance misuse or abuse is not exlusionary), pervasive developmental disorder (autistic disorder or Asperger disorder).
[5] In the clinical judgment of the investigator, currently meets criteria for a primary psychiatric disorder, e.g., Anxiety Disorder, Depressive Disorder, Tic Disorder or Tourette’s Syndrome (comorbid ADHD is permitted, cf. Incl. criteria section).
[6]Starts any psychotropic medication, including health-food supplements that the investigator feels could have central nervous system activity (for example, St. John’s Wort, melatonin), during the course of the study, or is taking any other excluded concomitant medication(s) specified in Section 5.7). (An ongoing long-term medication, e.g., to treat a comorbid disorder such as ADHD, is permitted as long as compound and dose are not changed throughout the course of the study).
[7]Has a history of hypersensitivity to neuroleptics, of tardive dyskinesia, or neuroleptic malignant syndrome.
[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 participation in the study.
[9] Has a known or suspected seizure disorder.
[10]Female patients who are pregnant or breastfeeding.
[11]Patients with a history of severe allergies to more than 1 class of medications or multiple adverse drug reactions.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method