A Randomized Controlled Trial of Buspirone for Anxiety in Autistic Youth
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Mean 16-Week Change in Pediatric Anxiety Rating Scale (PARS) 5-Item Total Score
研究概览
简要总结
The purpose of the study is to do a preliminary trial to determine if buspirone is effective, safe, and tolerable in autistic youth with anxiety.
详细描述
After being informed about the study and potential risks, all patients or their legal guardians giving written informed consent will be screened for study eligibility. Patients who meet the eligibility requirements will participate in a 16-week, flexibly-dosed, randomized controlled trial of buspirone versus placebo. The dose of buspirone will be adjusted over the first 12 weeks of the study and a stable dose will be maintained for the final four weeks of the trial. Adverse effects will be reviewed at each visit and standardized measures of anxiety will be conducted at weeks 4, 8, 12, and 16.
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
- •Age 7-17 years
- •Diagnosis of Autism Spectrum Disorder (ASD) confirmed by the study clinician using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria and Social Communication Questionnaire (SCQ)
- •Diagnosis of social phobia, separation anxiety disorder, or generalized anxiety disorder of at least moderate severity based on the Anxiety and Related Disorders Interview Schedule (ADIS), 5-item Pediatric Anxiety Rating Scale (PARS) score ≥10, and Clinical Global Impression Severity subscale (CGI-S) ≥4
- •IQ ≥50 based on Stanford Binet, 5th Edition Abbreviated IQ test or the Kaufman Brief Intelligence Test, 2nd Edition (KBIT-2)
- •Stable medications for ≥30 days
- •English speaking
- •Ability to swallow buspirone capsules or liquid suspension
排除标准
- •Known diagnosis of a genetic syndrome associated with ASD (e.g. Fragile X syndrome, Angelman syndrome) based on parent report
- •Known cardiac arrythmia based on parent report
- •Current primary diagnosis of bipolar disorder, psychosis, substance use disorder, posttraumatic stress disorder, eating disorder, or major depressive disorder in the opinion of the PI
- •Any past or present conditions that would make treatment with buspirone unsafe
- •Current use of any of the following psychotropic medications: SSRIs, SNRIs, mirtazapine, benzodiazepines, tricyclic antidepressants, monoamine oxidase inhibitors, mood stabilizers, or antipsychotics
- •Previous adequate trial of buspirone (≥20 mg/day for at least 4 weeks) or significant adverse effects
- •Aberrant Behavior Checklist Irritability subscale score (ABC-I) ≥18
- •Pregnancy or sexual activity without the use of an acceptable form of birth control in females of childbearing age
- •Acutely unstable medical/psychiatric condition (e.g. self-injury, suicidality) that would preclude study participation in the opinion of the PI
- •Inability to tolerate Bittium Faros device in the opinion of the parent or a known allergy to adhesives
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Buspirone
干预措施: buspirone (Drug)
结局指标
主要结局
Mean 16-Week Change in Pediatric Anxiety Rating Scale (PARS) 5-Item Total Score
时间窗: Baseline, Week 4, Week 8, Week 2, Week 16; Change from Baseline to Week 16 reported
The PARS, a clinician-administered measure of child anxiety symptom severity based on both patient and parent-report will be the primary outcome measure. It has demonstrated inter-rater and test-retest reliability, and has previously been used by our group as the primary outcome measure in a RCT of mirtazapine for anxiety in youth with ASD, demonstrating sensitivity to change. The 5-item PARS score will be the primary outcome measure for this trial. Scaled score ranges from 0-25 with higher scores indicating more severe anxiety symptoms.
次要结局
- Proportion of Participants who Responded to Treatment at 16 Weeks According to the Improvement Item of the Clinical Global Impression-Improvement (CGI-I) (Response Defined as CGI-I = 1 or 2)(Week 4, Week 8, Week 12, Week 16. Week 16 score reported.)
- Mean 16-Week Change in Clinical Global Impression Severity Subscale (CGI-S)(Baseline, Week 4, Week 8, Week 12, Week 16. Change from Baseline to Week 16 reported.)
- Mean 16-Week Change in Parent-Rated Anxiety Scale for Autism Spectrum Disorder (PRAS-ASD) Score(Baseline, Week 8, Week 16. Change from Baseline to Week 16 reported.)
研究者
Robyn P. Thom, M.D.
Principal Investigator
Massachusetts General Hospital