A Placebo Controlled Double-Blind, Parallel Group, Individualizing Dosing Study Optimizing Treatment of Adults With Attention Deficit Hyperactivity Disorder to an Effective Response With OROS Methylphenidate
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 357
- 主要终点
- Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Score (AISRS) Over Time Using the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Fourth Edition for Diagnosis
研究概览
简要总结
The purpose of this study is to compare the ADHD symptom response of adults with ADHD treated with OROS MPH to those treated with placebo.
详细描述
The hypothesis is that Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCL (OROS MPH) is safe and effective in improving Attention Deficit Hyperactivity Disorder (ADHD) symptoms in adults with ADHD when compared to placebo as demonstrated using specific study measures. This is a double-blind (neither participant nor investigator knows the name of the assigned study drug), randomized (study drug assigned by chance), placebo-controlled study to evaluate the efficacy and safety of OROS MPH using the optimal dose for each adult patient in the study with ADHD. The primary efficacy variable in this study is the change from baseline to final evaluation using the Adult ADHD Investigator Symptom Rating Scale (AISRS) to measure patient ADHD symptoms. Participants will also be assessed for adverse events throughout the study. Patients will initiate treatment with oral OROS MPH 18 mg or matching placebo at baseline and continue morning dosing with increases every week until an optimal dose is achieved, up to the maximum of 72 mg/day of OROS MPH or matching placebo. Eligible patients will remain in the study for a maximum of 6 weeks.
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
- •ADHD diagnosis (any type: Combined, Predominantly Inattentive, or Predominantly Hyperactive-Impulsive)
- •Patients with an Adult ADHD Investigator Symptom Rating Scale (AISRS) score greater than 24 at screening/baseline
- •Ability to read and understand English
排除标准
- •Any significant history of cardiovascular disease or cardiovascular disease detectable via ECG
- •History of diagnosis of substance or alcohol dependence or admission/hospitalization for rehabilitation for dependence
- •Current neurologic or psychiatric diagnosis that would make patient inappropriate for participation
- •Anxiety assessments of moderate or severe
- •Depression assessments of moderate or severe
- •History or current suicidal thoughts or attempts
- •Known allergies, hypersensitivity, or intolerance to OROS MPH
研究组 & 干预措施
001
OROS MPH Optimal Patient Dose (18 mg-72 mg) once daily by mouth for 6 weeks
干预措施: OROS MPH (Drug)
001
OROS MPH Optimal Patient Dose (18 mg-72 mg) once daily by mouth for 6 weeks
干预措施: OROS MPH Tablets (Drug)
002
Placebo Optimal Patient Dose (placebo to match 18 mg - 72 mg) once daily by mouth for 6 weeks
干预措施: Placebo (Drug)
002
Placebo Optimal Patient Dose (placebo to match 18 mg - 72 mg) once daily by mouth for 6 weeks
干预措施: Placebo Tablets (Drug)
结局指标
主要结局
Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Score (AISRS) Over Time Using the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) Fourth Edition for Diagnosis
时间窗: Baseline, endpoint (42 days or early discontinuation)
The Adult ADHD Investigator Symptom Rating Score (AISRS) assesses 18 core ADHD symptoms corresponding to the DSM-IV diagnostic symptoms for adult subjects based on the investigator's rating for each of the symptoms using a four point scale (0=None, 1=Mild, 2=Moderate, and 3=Severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The AISRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms).
次要结局
- Reaction Time Domain of the Stroop Test (Cognitive and Executive Function)(Baseline, 4 hour timepoint for extended days or last non-missing value for non-extended days on day 42 or early discontinuation (endpoint))
- Vigilance Domain (Complex Attention) of the Stroop Test/Shifting Attention Test (SAT)/Continuous Performance Test (CPT) (Cognitive and Executive Function)(Baseline, endpoint (42 days or early discontinuation))
- Cognitive Flexibility Domain of the Stroop/SAT Tests (Cognitive and Executive Function)(Baseline, 4 hour timepoint for extended days or last non-missing value for non-extended days on day 42 or early discontinuation (endpoint))
- Processing Speed Domain of the Symbol Digit Modalities Test (SDTM) (Cognitive and Executive Function)(Baseline, endpoint (42 days or early discontinuation))
- Global Executive Composite (GEC) Score of the Brief Rating Inventory of Executive Function for Adults (BRIEF-A)(Baseline, endpoint (42 days or early discontinuation))
- Performance and Daily Functioning Scale of the Adult ADHD Impact Module (AIM-A)(Baseline, endpoint (42 days or early discontinuation))
- Subject's Rating of Endicott Work Productivity Scale (EWPS)(Baseline, endpoint (42 days or early discontinuation))
- Subject's Rating of Dyadic Satisfaction Subscale (DSS)(Baseline, endpoint (42 days or early discontinuation))
- Subject's Rating of Satisfaction With Treatment Questionnaire - Overall, How Satisfied or Dissatisfied Are You With the Medication You Are Taking for ADHD?(Endpoint (42 days or early discontinuation))
- Responder Rate Using AISRS(Endpoint (42 days or early discontinuation))
- Clinical Global Impression - Severity of Illness Subscale (CGI-S)(Baseline, endpoint (42 days or early discontinuation))
- Significant Other's (a Spouse, Significant Other or Other Adult in the Household, Described in This Study as the Designated Observer) Rating of Adult ADHD Rating Scale IV(Baseline, endpoint (42 days or early discontinuation))
- Designated Observer's (DO) Global Executive Composite (GEC) Score of the Brief Rating Inventory of Executive Function for Adults (BRIEF-A)(Baseline, endpoint (42 days or early discontinuation))
- Designated Observer's (DO) Rating of Dyadic Satisfaction Subscale(Baseline, endpoint (42 days or early discontinuation))
- Designated Observer's (DO) Rating of Satisfaction With Treatment Questionnaire - Overall, How Satisfied or Dissatisfied Are You With the Medication for ADHD Your Partner is Taking?(Endpoint (42 days or early discontinuation))
- Adult ADHD Self-Report Scale (ASRS) Over Time(Baseline, endpoint (42 days or early discontinuation))
- Pittsburgh Sleep Quality Index (PSQI) Total Score(Baseline, endpoint (42 days or early discontinuation))
- Epworth Sleepiness Scale (ESS)(Baseline, endpoint (42 days or early discontinuation))