conduct disorder (CD), oppositional defiant disorder (ODD) and disruptive behavior disorder not otherwise specified (DBD-NOS)
Conditions
Interventions
Product Name: Zeldox
Pharmaceutical Form: Oral solution
INN or Proposed INN: Ziprasidone
Other descriptive name: (5-[2-[4-(1,2-Benzisothiazol-3-yl)-1- piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H- indol
Sponsors
Dept. Child & Adolescent Psychiatry Univ. Freiburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients enrolled in this study are to meet the following inclusion criteria: 1. The subject and the authorized legal representative must understand the nature of the study and be able to comply with protocol requirements. The representative must sign an Informed Consent Document and the subject must provide Written Assent. 2. The subject (male or female) must be between 7-17 (inclusive) years of age at screening. 3. The subject must have a primary diagnosis of Conduct Disorder [CD] (312.8), Oppositional Defiant Disorder [ODD] (313.81) or Disruptive Behavior Disorder not otherwise specified [DBD-NOS] (312.9) as defined by DSM-IV criteria and confirmed by the Kiddie-SADS-PL. 4. At the screening visit (Visit 1), subjects must have a score of 21 or more on the sum of the scales for conduct problems and for oppositional behaviour in the NCBRF-TIQ. 5. In the investigator's opinion, the subject must be likely to benefit from the therapy. 6. The subject is willing and able to discontinue any medications that are prohibited in this study (see Concomitant Medications table, Section 3.5.1). Any such medications must be discontinued at least 5 half-lives prior to the administration of double-blinded study medication. Patients who are receiving prohibited medications are to be considered for the protocol only If discontinuation of the medication does not compromise the welfare of the patient and/or alternative medication that is allowed by the protocol is available and appropriate for the patient. Psychotropic medications should be tapered down per accepted medical practice and the specific package insert instead of being abruptly discontinued. 7. Females of childbearing potential may be included provided that they are not pregnant, not nursing, and are practicing effective contraception and meet all of the following criteria: a. Are instructed and agree to avoid pregnancy during the study. b. Have a negative pregnancy test (ß-HCG) at screening and Visit 2. c. Use one of the following birth control methods: • an oral contraceptive agent, an intrauterine device (ILTD), an implantable contraceptive (e.g. Norplant), transdermal hormonal contraceptive (e.g. Ortho-Evra), or an injectable contraceptive (e.g. Depo-Provera) for at least one month prior to entering the study and will continue its use throughout the study; or • a barrier method of contraception, e.g., condom andlor diaphragm with spermicide while participating in the study. • abstinence for at least 3 months before the start of the study and intention to abstain from sexual activity during the study period. 8. Subjects must have an IQ > 55 best tested with the HAWIK-III, alternatively with the CFT-20 or K-ABC. Are the trial subjects under 18? yes Number of subjects for this age range: 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
Exclusion criteria: 1. Subjects who are clinically stable on treatment regimens that are being well tolerated and effective. 2. Subjects with any psychotic disorder. 3. Subjects with DSM-IV defined psychoactive substance or alcohol abuse/dependence (does not apply to nicotine or caffeine) within the preceding 1 month. 4. Subjects who are judged by the investigator as being at imminent risk of suicide. 5. Subjects who are judged by the investigator as being at imminent risk of homicide 6. Subjects with autism or other pervasive developmental disorder. General Medical 7. Subjects with any serious, unstable illness including hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrinologic (including controlled or uncontrolled Type I diabetes), immunologic, hematologic, dermatological, oncological, or neurological disease (including any history of seizure or epilepsy). Subjects with a history of febrile seizures are eligible if no seizures have occurred during the last 3 years. 8. Subjects with a history of syncopal episodes (sudden loss of consciousness with loss of postural tone and not preceded by a pre-syncopal phase) or unexplained loss of consciousness. Subjects with a history of occasional syncopes ofp robable vasovagal origin (onset not sudden but preceded by a pre-syncopal phase, presence of predisposing factors such as blood sampling procedure, standing, hot shower, hair curling, etc) are eligible. 9. Subjects with any medical condition or dietary habit that has a significant potential to alter the absorption of the study drug; or subjects taking any medication that may alter drug absorption. (e.g. anorexia nervosa, bulimia, chronic use of laxatives). 10. Subjects with uncorrected hypothyroidism or hyperthyroidism or whose thyroid function and medication regimen have been stable less than 1 month. 11. Subjects with any screening laboratory value that deviates significantly from the upper or lower limits of the normal reference range. SGOT and SGPT must be within 2 X and total bilirubin must be within 1.5 X times of the upper limits of the reference range. Subjects with an isolated increase of unconjugated bilirubin (Gilbert's syndrome) are eligible. 12. Subjects with screening K+, Mg++ or Ca++ below the normal range. 13. Subjects with a history of chronic hepatitis, known serologic evidence of acute hepatitis or chronic hepatitis (positive HbsAg), or subjects with known hepatitis C antibodies and elevated LFTs. 14. Subjects known to be HIV positive. Cardiovascular 15. Subjects with a history of significant cardiovascular disease, including conditions that have previously required treatment or acute evaluation, or significant concurrent cardiovascular disease, including uncontrolled hypertension (sitting diastolic pressure >90 mm Hg and/or sitting systolic pressure > 140 mm Hg with or without treatment), congestive heart failure, or congenital heart disease. Non-clinically significant sinus bradycardia or sinus tachycardia will not be considered significant medical illnesses and would not exclude a subject from the study. Isolated atrial septal defect (ASD), ventricular septal defect (VSD, or patent ductus arteriosus (PDA) will not be considered significant medical illnesses if they are surgically corrected. 16. Subjects with a history of cardiac arrhythmias, conduction abnormalities or known personal history of QT prolongation (including congenital long QT syndrome). 17. Subjects with a known genetic risk for prolonged QT syndrome 18.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of the treatment with ziprasidone of conduct problems and aggressive behavior by rating, reflecting and assessing subject’s condition with the Nisonger Child Behavior Rating Form for typical IQ (NCBRF-TIQ). Primary outcome measures are the subscales “Conduct Problem” (such as cruelty to animals, misbehaving, fighting) and “Oppositional Behavior” (such as arguing, disobedience, stubborn). Symptom rating will be done by the subject’s primary caregiver.;Secondary Objective: To assess the safety and tolerability of the treatment with ziprasidone in children and adolescents. To assess the efficacy by rating, reflecting and assessing the subject’s condition on the Clinical Global Impressions-Severity of Illness scale (CGI-S) and the Global Impressions-Improvement scale (CGI-I) by the psychiatrist. To assess the correlation between serum levels and dosage, efficacy and side effects. ;Primary end point(s): The primary endpoint is change from baseline in the NCBRF-TIQ conduct and oppositional behavior sub-score. The primary time point is Week 9. | — |
Countries
Germany
Outcome results
None listed