A Controlled Trial of Sertraline in Young Children With Autism Spectrum Disorder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change in Mullen Scales of Early Learning - Expressive Language Raw Score
研究概览
简要总结
This study is a control trial of sertraline (Zoloft) in children aged 2 to 5 years old inclusive with Autism Spectrum Disorder. The trial is six months long, and each participant will receive a series of tests at both the beginning and end of the study. The researchers hope to show improvements in language and social deficits.
详细描述
This is a single center study and the UC Davis MIND Institute for Autism Spectrum Disorder (ASD) patients aged between 2 years and 5 years old inclusive funded by the Health Resources and Services Administration (HRSA). It is a double-blind control trial of sertraline (Zoloft), an anti-depressant typically used in the treatment of depression, obsessive-compulsive disorder, panic disorder, and other conditions. The researchers are investigating the use of this selective serotonin reuptake inhibitor (SSRI) in ASD because a retrospective study has shown significant improvements in language and social deficits. There is also emerging evidence regarding the stimulation of brain-derived neurotrophic factor (BDNF) and the stimulation of neurogenesis when an SSRI is given early on in the development of animal models of Down syndrome. The researchers hope to see improvements in language stimulation, social gaze and social reciprocity, spatial attention, and a decrease in autistic behaviors.
The aim of this study is to carry out a double-blind placebo controlled trial of sertraline in children with ASD who are between the ages of 2 years and 5 years old inclusive. At baseline, the researchers will assess behavioral and cognitive development. Each participant will be involved in this trial for a period of six months. This will include three visits to the UC Davis MIND Institute and eight phone calls. The researchers will also assess the side effects of the sertraline treatment throughout 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 24 Months 至 72 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documentation of Autism Spectrum Disorder with Diagnostic and Statistical Manual for Mental Disorders-Fifth edition, criteria as well as a standardized autism assessment such as the Autism Diagnostic Observation Schedule or the Autism Diagnostic Interview-Revised.
- •Subject between the ages of 24-72 months of age.
- •A reliable parent or caregiver who can report the side effects and communicate effectively with the research team.
- •Stable medications during the two months prior to enrollment.
- •Currently receiving interventions in the community or school for Autism Spectrum Disorder
排除标准
- •Current or past Selective Serotonin Reuptake Inhibitor treatment.
- •Other serious co-morbid medical disorders affecting brain function and behavior, including uncontrolled seizures.
研究组 & 干预措施
Sertraline Liquid Placebo
The placebo will be dosed in an age depended manner. Participants aged 2-3 years of age will be given 2.5 mg of liquid placebo once per day for a period of six months. Participants aged 4 years to 6 years will be given 5 mg of liquid placebo once per day for a period of six months.
干预措施: Sertraline Liquid Placebo (Drug)
Sertraline Active Medication
Liquid sertraline (20 mg/cc) will be dosed in an age depended manner. Participants aged 2-3 years of age will be given 2.5 mg of liquid sertraline once per day for a period of six months. Participants aged 4 years to 6 years will be given 5 mg of liquid sertraline once per day for a period of six months.
干预措施: Sertraline (Drug)
结局指标
主要结局
Change in Mullen Scales of Early Learning - Expressive Language Raw Score
时间窗: From baseline visit to six-month visit
The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the baseline and 6-month follow-up raw scores from the expressive language scale. This scale's raw scores range from 0 to 50. The lower the score on this scale, the weaker the ability; the higher the score, the greater the ability. The MSEL was administered at the baseline visit and at the 6-month follow-up visit.
Change in Mullen Scales of Early Learning - Combined Age Equivalent Score
时间窗: From baseline visit to six-month visit
The Mullen Scales of Early Learning (MSEL) is a cognitive test to measure cognitive ability and language development. The test has five scales: gross motor, visual reception, fine motor, receptive language, and expressive language. Shown here are the baseline and 6-month follow-up combined age equivalent scores, calculated as the sum of the age equivalent scores from each scale. The combined score ranges from 0 to 280. The lower the score on this scale, the weaker the ability; the higher the score, the greater the ability. The MSEL was administered at the baseline visit and at the 6-month follow-up visit.
次要结局
- Preschool Language Scale-Fifth Edition - Total Language Raw Score(At six-month visit)
- Vineland Adaptive Behavior Scales, Second Edition (Vineland-II) Adaptive Behavior Composite Standard Score(At six-month visit)
- Clinical Global Impression Scale-Severity (CGI-S)(At baseline visit)
- Preschool Anxiety Scale-Revised - Total Score(At six-month visit)
- Clinical Global Impression Scale-Improvement (CGI-I)(At six-month visit)
- Sensory Processing Measure-Preschool - Social Participation Raw Score(At six-month visit)
- Visual Analog Scale - Language/Communication Score(At six-month visit)
研究者
Randi J. Hagerman, MD
UC Davis MIND Institute Medical Director
University of California, Davis