Double-Blind, Randomized, Placebo-Controlled, Single- Center, Dose Optimization Study Evaluating Efficacy and Safety of Guanfacine Hydrochloride in Combination With Psychostimulants in Adults Aged 18-65 Years With a Diagnosis of ADHD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- ADHD-RS Change From Baseline to Endpoint
研究概览
简要总结
This is considered an investigator-initiated clinical research trial, which means that your study doctor is researching a particular medication (in this case a medication that is currently FDA- approved) for the treatment of AD/HD in individuals ages 6-17. The medication is guanfacine hydrochloride.
The hypothesis is that this medication could be used in adults with Attention Deficit/Hyperactivity Disorder who have not received satisfactory results with their current stimulant ADHD medication. The study drug is investigational for use in adults. Investigational means it has not been approved by the U.S. Food and Drug Administration (FDA) for use in adults.
详细描述
The purpose of this study is to determine whether guanfacine hydrochloride used as an adjunct therapy (to subjects' current stimulant medication) would bring about a statistically significant improvement in AD/HD symptoms.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and females (non pregnant) ages 18-65
- •Current diagnosis of ADHD and have met the DSM-IV-TR criteria for ADHD
- •Currently taking an adequate dose stimulant to treat their ADHD (with a sub-optimal response). A suboptimal response is determined by a baseline score of 28 or greater on the ADHD-RS or a CGI score of 4 or greater.
- •Subjects must be of normal intelligence
- •English speaking
- •Able to swallow pills.
排除标准
- •Non pregnant or lactating females
- •Severe Axis I and Axis II disorders
- •Tourette's
- •Heart disease or any other serious chronic or acute unstable medical conditions/illnesses that would compromise participation or likely lead to hospitalization during the duration of the study.
- •A known history or presence of cardiovascular, hepatic, renal, respiratory, or hematologic abnormalities, narrow angle glaucoma, or any other unstable medical or psychiatric conditions (as judged by the primary investigator)
- •A current or recent history (within the past 6 months) of suspected substance abuse and/or drug dependence as defined by DSM-IV-TR criteria
- •Healthy weight (not under or over as judged by investigator)
- •No immediate family member of the investigator or research staff No involvement in a research study in the last 30 days.
研究组 & 干预措施
Guanfacine Hydrochloride
- mg Guanfacine Hydrochloride (orally, QD)
- mg Guanfacine Hydrochloride (orally, QD)
- mg Guanfacine Hydrochloride (orally, QD)
- mg Guanfacine Hydrochloride (orally, QD)
- mg Guanfacine Hydrochloride (orally, QD)
- mg Guanfacine Hydrochloride (orally, QD)
干预措施: Guanfacine Hydrochloride (Drug)
Sugar Pill
- mg Placebo
- mg Placebo
- mg Placebo
- mg Placebo
- mg Placebo
- mg Placebo
干预措施: Placebo (Other)
结局指标
主要结局
ADHD-RS Change From Baseline to Endpoint
时间窗: 0 weeks, 8 weeks
The ADHD-RS is an 18-item scale based on DSM-IV criteria for ADHD. Each item is rated using a likert scale from 0 (none) to 3 (severe), with a total score range of 0-54, with higher scores indicating more symptoms/severity. In this study, we compared the mean change in ADHD-RS total score from baseline to endpoint of the study.
次要结局
- The Clinical Global Impression (Severity)(0 weeks, 8 weeks)
- The Clinical Global Impression- Improvement (CGI-I)(8 weeks)