Galantamine Versus Placebo in Childhood Autism
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Autism Diagnostic Observation Schedule-Generic (ADOS-G)- Change from Baseline to Final Visit
研究概览
简要总结
Autism is a severe neurodevelopmental disorder that affects up to 16 in 10,000 individuals. It is a pervasive developmental disorder affecting social, communicative, and compulsive/repetitive behaviors characterized by stereotypic complex hand and body movements, craving for sameness, and narrow repetitive interests. Autism severely impacts both the affected individual and family members.
The proposed study is designed to assess the efficacy of treatment with Galantamine vs. placebo in childhood/adolescent autism fulfilling DSM-IV and Autism Diagnostic Interview (ADI) criteria. We therefore hypothesize:
- Galantamine will be superior to placebo in the acute treatment of global autism.
- Galantamine will be superior to placebo in improving functional ability.
- Galantamine will be superior to placebo in improving language function.
- Galantamine will be superior to placebo improving irritable and hyperactive behavior.
- Galantamine will be superior to placebo in improving social deficits.
详细描述
Once enrolled in the study, subjects will receive evaluations and testing to determine if they meet the necessary criteria for admission into study treatment. Subjects will not be responsible for the costs of any evaluations or tests conducted as part of this study.
First, subjects will receive a psychiatric and medical evaluation by the study psychiatrist to see if she/he has any psychiatric or medical illnesses that would interfere with their ability to participate in this study. These evaluations may take up to an hour to complete. In addition, subjects will be asked to participate in a psychiatric interview designed to determine the child's diagnosis and current problem areas. The subject's parent will also be asked to fill out psychiatric questionnaires. The interview and questionnaires may take up to 4 hours to complete.
Second, urine and blood samples will be needed for routine tests two times during this study (before any study related tests are done, and at the end of the study). Two teaspoons of blood will be drawn each time. The urine sample will be analyzed in order to assess kidney function and to screen for the presence of drugs (such as cocaine, marijuana, heroin, etc.). A positive drug screen would result in the inability of the child to participate in this study. Drug screen results will be kept confidential. In addition, an electrocardiogram will be performed to determine heartbeat.
Lastly, a pregnancy test will be conducted on the urine sample if the child is female and has reached puberty. The child should not be in this study if she is pregnant or a nursing mother. A positive urine pregnancy test would cause the child to be removed from the study. If the child is sexually active, she must be using an effective method of birth control during her participation in this study. Acceptable methods of birth control are oral contraceptive medications (the administration of which must be parentally supervised), IUD, depot medication and tubal ligation.
Subjects will be assigned by chance to receive either the active medication (Galantamine) or placebo (sugar pill) for 12 weeks, much like the flip of a coin. Neither the parent/child nor the investigator will know which of the two treatments the child is receiving. The child has a 50% chance of being assigned to receive placebo during the study or the active medication, Galantamine, during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Subjects with any of the following past or present mental disorders: psychotic disorders, mood disorders, including bipolar disorders.
- •Subjects who have displayed significant self-injurious behavior (children who have caused visible harm to themselves).
- •Subjects with active seizure disorder (seizures within the past six months).
- •Subjects with clinically significant or unstable medical illness, including patients with current evidence of clinically significant hematopoietic, or cardiovascular disease.
- •Subjects with present or history of the following:
- •gastrointestinal, liver, kidney, or other known conditions which will presently interfere with the absorption, distribution, metabolism, or excretion of drugs,
- •seizure disorders (active), cerebrovascular disease or brain trauma as etiology of autistic behavior,
- •clinically significant unstable endocrine disorder, such as hypo- or hyperthyroidism or diabetes,
- •recent history or presence of any form of malignancy.
- •Subjects who report significant improvement of autism symptoms and behaviors to current medications or have only global autism ratings on the CGI of absent, minimal or mild severity, or who are more than minimally verbal.
- •Subjects whose global autism ratings are assessed as being absent, minimal or mild.
- •Treatment within the previous 30 days with any drug known to have a well-defined potential for toxicity to a major organ.
- •Subjects with clinically significant abnormalities in laboratory tests or physical exam.
- •Subjects likely to require any other psychotropic medication during the study, with the exception of clonidine for insomnia (started at least one month prior to entrance into the study), as well as anticonvulsants at a constant dose for stable seizure disorder or, unless otherwise permitted.
- •Subjects unable to tolerate taper from psychoactive medication, if specified.
- •Subjects with a history of hypersensitivity or severe side effects associated with the use of galantamine, or other acetylcholinesterase inhibitors.
- •Subjects with a history of prior treatment with galantamine of 4mg/day for 6 weeks.
- •Subjects who have received any of the following interventions within the prescribed period before starting treatment:
- •investigational drugs within the previous 30 days.
- •monoamine oxidase inhibitors within the previous fourteen days.
- •long-acting phenothiazines within the previous six weeks.
- •other psychotropic drugs within the previous seven days, unless otherwise permitted.
- •Subjects with any organic or systemic disease or patients who require a therapeutic intervention, not otherwise specified, which would confound the evaluation of the safety of the study medication.
- •Subjects who reside in a remote geographical area or who do not have regular access to transportation to the clinical facility.
结局指标
主要结局
Autism Diagnostic Observation Schedule-Generic (ADOS-G)- Change from Baseline to Final Visit
Clinical Global Impression Improvement (CGI)- Change from Baseline to Final Visit
Aberrant Behavior Checklist (ABC) (hyperactivity/irritability sections)- Change from Baseline to Final Visit
Vineland Adaptive Behavior Scale- Change from Baseline to Final Visit
MacArthur Communicative Development Inventory (MCDI)- Change from Baseline to Final Visit
Conners' Parent Rating Scale-Revised: Long form (CPRS-R:L)- Change from Baseline to Final Visit
次要结局
未报告次要终点