Ziprasidone for Severe Conduct and Other Disruptive Behavior Disorders in Children and Adolescents - a Placebo Controlled, Randomized, Double Blind Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Nisonger Child Behavior Rating Form for typical IQ (NCBRF-TIQ): Combined subscales "Conduct Problem" and "Oppositional Behavior"
研究概览
简要总结
To investigate and compare the efficacy, safety and tolerability of ziprasidone versus placebo in the treatment of conduct disorder (CD), oppositional defiant disorder (ODD) and disruptive behavior disorder not otherwise specified (DBD-NOS) of older children and adolescents in an outpatient setting.
Conduct and other behavior disorders are some of the most common forms of psychopathology in children and adolescents. The main characteristic of these disorders is a repetitive and persistent pattern of antisocial, aggressive or defiant behavior that involves major violations of age-appropriate expectations or norms. According to the guidelines of the German Society for Child & Adolescent Psychiatry & Psychotherapy (Deutsche Gesellschaft für Kinder- und Jugendpsychiatrie und -psychotherapie DGKJPP), the European Society for Child and Adolescent Psychiatry (ESCAP), and the American Academy of Child and Adolescent Psychiatry (AACAP) currently no standard pharmacotherapy is established and recommended for children and adolescents. However Risperidone has been shown to be effective in the treatment of patients with disruptive behavior disorders and below average IQ.
详细描述
Trial Design:
A placebo-controlled, parallel-group, randomized, double-blind, single center design that includes a 3-weekly baseline period for finding the best individual dose, a 6-weeks treatment period and a 2-weeks washout period.
Study Agent / Placebo - Dosage and Route of Administration:
Study medication will first be dispensed at Visit 2 (day 1). Treatment assignments will be made in accordance with the randomization sequence. At each medication visit (Visit 2 to Visit 7), subjects will receive one bottle for the following week (Visit 2 to Visit 4) resp. the following two weeks (Visit 5 to Visit 7). Only qualified personnel may dispense study medication.
The study population will be randomized equally to the verum or placebo group at Visit 2. All patients will receive an initial oral course starting with 5mg/d Ziprasidone Hydrochloride or placebo for patients with a body weight ≤ 50 kg and 10 mg/d Ziprasidone Hydrochloride or placebo for patients with a body weight > 50 kg for the first week in the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •The subject (male or female) must be between 7-17 (inclusive) years of age at screening.
- •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.
- •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.
- •In the investigator's opinion, the subject must be likely to benefit from the therapy.
- •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.
- •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:
- •Are instructed and agree to avoid pregnancy during the study.
- •Have a negative pregnancy test (β-HCG) at screening and Visit
- •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 and / or 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.
- •Subjects must have an IQ > 55 best tested with the HAWIK-III, alternatively with the CFT-20 or K-ABC.
排除标准
- 未提供
研究组 & 干预措施
1
Ziprasidone Hydrochloride oral solution with individual titration from 5 mg to 40 mg per day
干预措施: Ziprasidone Hydrochloride (Drug)
2
Placebo oral solution
干预措施: Placebo (Drug)
结局指标
主要结局
Nisonger Child Behavior Rating Form for typical IQ (NCBRF-TIQ): Combined subscales "Conduct Problem" and "Oppositional Behavior"
时间窗: Visit 2 to Visit 9 (week 0, 1, 2, 3, 5, 7, 9 and 11)
次要结局
- Assessment of the safety and tolerability by adverse event documentation.(Visit 2 to Visit 9 (week 0, 1, 2, 3, 5, 7, 9 and 11))
- Assessment of the efficacy by the Clinical Global Impressions-Severity of Illness scale (CGI-S) and the Global Impressions-Improvement scale (CGI-I).(Visit 2 to Visit 9 (week 0, 1, 2, 3, 5, 7, 9 and 11))
- Correlation between dosage, efficacy and adverse events.(Visit 2 to Visit 9 (week 0, 1, 2, 3, 5, 7, 9 and 11))
- Ziprasidone serum levels(Visit 5 (week 3) and Visit 8 (week 8))
- Correlation between serum level, efficacy and adverse events(Visit 5 (week 3) and Visit 8 (week 8))