NCT00609531已完成1 期
Functional MRI Evaluation of the Effect of Citalopram in Autism Spectrum Disorders
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Functional Magnetic Resonance Imaging
研究概览
简要总结
The purpose of this proof of concept study is to use functional magnetic resonance imaging and behavioral assessments to investigate the effect of citalopram on restricted repetitive behaviors in people with autism spectrum disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Ambulatory status (outpatient) at time of consent
- •Age 10-55 years
- •Clinical diagnosis of Autism Spectrum Disorder
- •IQ greater than or equal to 70
- •Score greater than 8 on Children's Yale-Brown Obsessive Compulsive Scale
- •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]
排除标准
- •Age less than 10 years or greater than 55 years, at time of consent
- •Estimated IQ < 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 (as verified by testing prior to both initial dose administration of citalopram or placebo and prior to magnetic resonance imaging) due to the risk that may be associated with SSRI treatment and magnetic resonance imaging on fetal health
- •Medical contraindications to SSRI therapy as determined by history (including induction of mania or hypomania during SSRI therapy, or known drug allergy)
- •Concomitant medication that would interfere with study participation
- •Prior history of citalopram treatment failure at appropriate doses and duration
- •Prior history of treatment failure to two previous SSRI trials at appropriate doses and duration
- •Ongoing need for psychoactive medication other than study medication [excepting stable doses (greater than three months duration) of anticonvulsant medication for seizure disorder, or diphenhydramine (Benadryl®)for sleep]
研究组 & 干预措施
Active
Experimental
Individuals with an Autism Spectrum Disorder receiving citalopram
干预措施: Citalopram (Drug)
Placebo
Placebo Comparator
Individuals with an Autistic Spectrum Disorder receiving placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Functional Magnetic Resonance Imaging
时间窗: two 2-hr scans
Clinicians Global Improvement Scale
时间窗: Upon study completion
次要结局
- Childrens Yale-Brown Obsessive Compulsive Scale(Baseline, wks 2, 4, 8, endpoint)
研究者
Gabriel Dichter
Associate Professor of Psychiatry
University of North Carolina, Chapel Hill
研究点 (1)
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