Evaluation of Pharmacokinetics and Profile of Clinical Response of Subacute Lisdexamfetamine Dimesylate (Vyvanse) Treatment vs. Clinical Response to Subacute Immediate Release Mixed Amphetamine Salt Therapy in Adult ADHD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Attention Deficit Hyperactivity Disorder- Rating Scale (ADHS-RS)
研究概览
简要总结
The purpose of this study is to examine the effectiveness and length of effect of Vyvanse on lessening Attention-Deficit/Hyperactivity Disorder symptoms in adults. The study will also investigate the safety and tolerability of Vyvanse in adults with ADHD.
详细描述
Protocol Summary:
Effectiveness and Duration of Effect of Open Treatment in Adult ADHD Patients Treated with Lisdexamfetamine Dimesylate- LDX (Vyvanse)
The primary objective of this study is to evaluate the effectiveness and duration of effect of LDX for the treatment of ADHD symptoms in adults. The study will be a 12-week open label extension with 25 adult participants who completed a cross-over study of adherence/efficacy of Adderall Immediate Release (IR) vs. Adderall Extended Release (XR).
The secondary objective is to provide information regarding tolerability, dosing and titration of LDX in the adult population with ADHD.
An additional fifteen participants will be recruited using advertising and previous Mental Health and Addictive Behaviour Research Program (MHADRP) studies will be offered treatment with LDX. All participants will be diagnosed with ADHD using the Adult Clinician Diagnostic Scale (ACDS). We will be collecting demographic information, administering the Scheduled Clinical Interview for DSM Disorders (SCID), collecting medical history, previous drug therapy, and the participant will have a physical with the physician. A coordinator will give an electrocardiogram (ECG), and collect a blood sample for blood chemistry and hematology.
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
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At the time of consent, are between the ages of 18-55, inclusive.
- •Meet DSM-IV criteria for ADHD as assessed by the Adult ADHD Clinician Diagnostic Scale (ACDS) v1.
- •Female participants of childbearing potential must test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control during the study. Females of childbearing potential are defined as women not surgically sterilized and are between menarche and 2 years post-menopause.
- •Must have a satisfactory medical assessment with no clinically significant abnormalities as determined by medical history, physical exam, ECG, and clinical laboratory testing.
- •Must be able to swallow capsules.
- •Must be able to begin the daily dose of study medication in the morning.
- •Must be off all ADHD therapies for one week (psychostimulants) and three weeks (non-stimulants).
- •In the opinion of the investigator, the subject must understand and be able, willing and likely to fully comply with the study procedures and restrictions.
- •Must have given signed and dated informed consent in accordance with Good Clinical Practice (GCP) Guidelines.
排除标准
- •Participants with a positive urine drug result at Screening.
- •Anyone who meets current DSM-IV-TR criteria for alcohol or any non-alcohol substance abuse or dependence disorder (excluding nicotine).
- •Participants with controlled depressive or anxiety disorders may not participate if, in the opinion of the Principal Investigator, their medications will interfere with safety or efficacy assessments.
- •Participants with any concurrent chronic or acute illness or unstable medical condition that could, in the opinion of the study physician, confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol.
- •Participants with hypertension at screening, indicated by a blood pressure reading of 135/90 and heart rate above 120bmp.
- •Female participants of childbearing potential who test positive for pregnancy at the time of enrollment based on a urine pregnancy test, or who do not agree to use a reliable method of birth control during the study. Females of childbearing potential are defined as women not surgically sterilized and are between menarche and 2 years post-menopause.
- •Participants who work the night shift or another schedule that would preclude beginning the daily dose of study medication in the morning.
- •Participants who in the investigator's opinion meet any of the exclusionary criteria specified on the FDA label of Vyvanse.
研究组 & 干预措施
LDX Treatment
Eligible participants received 12 weeks of open-label treatment. Those on treatment prior to baseline underwent a 7-day (for amphetamine or methylphenidate) or 28-day (for atomoxetine or other medications) washout period prior to initiating LDX treatment. The starting dose was 30mg/day, which could be titrated up by 20mg/day during visits 2-6 (for a maximum dose of 70mg/day). At discretion of investigator, the dose could be down-titrated by 20mg/day during visits 4-6. Once the dose was optimized (after visit 6), the dose was maintained for 8 weeks.
干预措施: LDX Treatment (Drug)
结局指标
主要结局
Attention Deficit Hyperactivity Disorder- Rating Scale (ADHS-RS)
时间窗: 12 weeks
The ADHD-RS with adult ADHD prompts is a semi-structured scale that consists of 18 items that directly correspond to the 18 DSM-IV symptoms of ADHD, and is designed to assess current symptomatology19. Each item is scored on a 4-point scale ranging from 0 (none) to 3 (severe).Each item on the 18-item measure is scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms), yielding a possible total score of 0-54. A score of 0-16 means "Unlikely to have ADHD"; a score of 17-23 "Likely to Have ADHD" ; 24 or greater-Highly Likely to have ADHD
次要结局
- Change in Measure of Smoothness of Effect Using Adult ADHD Medications Smoothness of Effect Scale (AMSES)(Visits 0 and 12)
- Correlation Between AMRS (In Clinic) and ADHD-RS(Visits 0 and 12)
- Change in Symptom Rebound Score Using the Adult ADHD Medication Rebound Scale (AMRS).(Week 0 to Week 12)
- Psychometric Validation of AMRS(Weeks 0-12)
- Change in Correlation Between AMRS and TASS(Visits 0 and 12)
- Correlation Between In-Clinic AMRS and ASRS v.1.1 Symptom Checklist(Baseline to Week 12)
- Psychometric Validation of AMSES(Weeks 0-12)