Pilot Study of the Effect of Aripiprazole Treatment in Autism Spectrum Disorders on Functional Magnetic Resonance Imaging (fMRI) Activation Patterns and Symptoms
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Baseline and Week 8scores on Children's Yale-Brown Obsessive Compulsive Scale - Pervasive Developmental Disorder Version
研究概览
简要总结
This is an 8 week research study of aripiprazole (abilify) which is used to reduce irritable behaviors in autism spectrum disorders. All participants will receive active study medication. Participants will also receive diagnostic and cognitive evaluations at no cost. Participants will be required to undergo two fMRI (functional magnetic resonance imaging scans) where we will take pictures of your brain while performing simple tasks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female of any race or ethnicity
- •ambulatory status (outpatient) at time of consent
- •age 10-55 inclusive at time of consent
- •clinical diagnosis of autism spectrum disorder and meets screening criteria on the Social Communication Questionnaire as well as either the Autism Diagnostic Observation Schedule (ADOS) or the Autism Diagnostic Interview-Revised (ADI-R) administered by raters trained to research reliability.
- •estimated IQ greater than 70 and capable of making an informed decision based on assessment of their understanding and judgment
- •Children's Yale-Brown Obsessive Compulsive Scale: Modified for Pervasive Developmental Disorders (PDD-CYBOCS) > 8 as assessed during telephone screening.
- •Free of psychoactive medication for at least: one month for fluoxetine; two weeks for other SSRIs and neuroleptics; and five days for stimulants prior to MRI scanning [excepting stable doses (greater than three months duration) of anticonvulsant medication for seizure disorder]
- •Currently taking psychoactive medication that is not providing sufficient relief of repetitive behaviors and willing to discontinue all psychoactive medication for the duration of the study.
- •Judged reliable for medication compliance and agreeing to keep follow-up study appointments.
排除标准
- •Age less than 10 years or greater than 55 years at time of consent
- •Estimated IQ less than 70
- •Uncontrolled epilepsy (seizure within 6 months prior to consent)
- •Presence of medical conditions that might interfere with participation, or where participation would be contraindicated.
- •History of neurological injury: head trauma, poorly-controlled seizure disorder (seizure within the preceding six months), stroke, prior neurosurgery, or under the care of a neurologist or neurosurgeon as determined by interview
- •History of claustrophobia
- •Implanted or irremovable metal in the body (including certain tattoos and permanent make-up).
- •Current pregnancy in females
- •Inability to communicate satisfactorily and directly (without a translator) in English
- •Medical contraindications to aripiprazole therapy as determined by history (including induction of neuroleptic malignant syndrome, dystonic reaction, or known drug allergy)
- •Ongoing need for psychoactive medication other than study medication [excepting stable doses (greater than 3 months duration) of anticonvulsant medication for seizure disorder or diphenhydramine for sleep
- •prior history of aripiprazole treatment failure at appropriate doses and duration
- •clinically significant low white blood cell count at baseline
研究组 & 干预措施
Open-Label, Flexible-Dose Aripiprazole
This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.
干预措施: Aripiprazole (Drug)
结局指标
主要结局
Baseline and Week 8scores on Children's Yale-Brown Obsessive Compulsive Scale - Pervasive Developmental Disorder Version
时间窗: Baseline ("Pre-Dose") to 8 Weeks ("Post-Dose")
The Children's Yale-Brown Obsessive Compulsive Scale - Pervasive Developmental Disorder Version (CY-BOCS-PDD) is a clinician-rated interview designed to evaluate repetitive behavior in children with pervasive developmental disorders (PDDs). It is a modification of the Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS), developed to assess typically-developing children with obsessive compulsive behavior. Because of language limitations in children with PDDs the CY-BOCS-PDD only includes the five compulsion items: Time Spent, Interference, Distress, Resistance of repetitive behavior, and Control of repetitive behavior. Each item is rated from 0 (none) through 4 (extreme), and scores can range from 0 to 20, with higher scores reflecting more severe symptoms. Usually a score \> than 8 is considered clinically significant.
次要结局
- Total Repetitive Behavior Scale - Revised (RBS_R)(baseline week 0, 8 weeks)
研究者
Linmarie Sikich, MD
Associate Professor of Psychiatry
University of North Carolina, Chapel Hill