Attention & Memory Impairments in Menopausal Women: A Possible Role for Vyvanse?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Brown Attention Deficit Disorder Scale (BADDS)
研究概览
简要总结
The purpose of this study is to determine whether a medication called Vyvanse® (lisdexamfetamine; LDX) has an impact on cognitive functioning, specifically measures of sustained attention, verbal encoding and recall and working memory, in menopausal aged women. LDX is a medication used to treat attention deficit hyperactivity disorder (ADHD). The cognitive difficulties that menopausal women report experiencing are typical of adults who are diagnosed with ADHD. The investigators will assess whether or not LDX is effective in alleviating those cognitive disruptions when compared to a placebo.
详细描述
Midlife decline in cognitive function, particularly attention and working memory, is a frequent complaint for which menopausal women seek clinical intervention. Many of the cognitive complaints detected in menopausal women including, short-term memory, organization of tasks, sustaining focus and concentration, and regulating emotions, overlap with symptoms frequently reported by adults with ADHD. These impairments are reported by many women who have no previous history of ADHD, and appear to be linked to reduced estrogen levels occurring in menopause.
This is a double-blind, placebo-controlled, cross-over study testing whether LDX, a stimulant medication, would be effective in alleviating midlife onset impairments of attention and working memory among menopausal women. There will be 3 days in which subjects will undergo a brief cognitive testing assessment; the first testing period will occur at baseline prior to beginning LDX or placebo treatment (PT) in trial A; the second testing period will occur following 4 weeks of double blind LDX or PT; and the final testing period will take place after another 4 weeks of double blind LDX or PT in Trial B. Each cognitive test period will involve 2 separate cognitive testing batteries that will take approximately 120 minutes total to complete.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women ages 45 to 60 will be eligible for this study if they:
- •Are within 5 years of their last menstrual period;
- •Are able to give written informed consent;
- •Must have clear urine toxicology screen upon recruitment;
- •Are fluent in written and spoken English;
- •Must have negative urine pregnancy test if still menstruating.
排除标准
- •History of seizures;
- •History of cardiac disease including known cardiac defect or conduction abnormality;
- •Abnormal electrocardiogram during screening;
- •Use of estrogen therapy within previous 6 months;
- •Current pregnancy or planning to become pregnant.
- •Presence of a contraindication to treatment with stimulant medication; this would include the presence of hypertension, coronary disease, atrial fibrillation, and arrhythmia.
研究组 & 干预措施
Lisdexamfetamine, then placebo
Participants first received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks followed by a 2-week washout, then they received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.
干预措施: Lisdexamfetamine (Drug)
Lisdexamfetamine, then placebo
Participants first received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks followed by a 2-week washout, then they received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks.
干预措施: Placebo (Drug)
Placebo, then Lisdexamfetamine
Participants first received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks followed by a 2-week washout, then they received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks.
干预措施: Lisdexamfetamine (Drug)
Placebo, then Lisdexamfetamine
Participants first received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks followed by a 2-week washout, then they received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Brown Attention Deficit Disorder Scale (BADDS)
时间窗: Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks)
The BADDS questionnaire is a clinician administered questionnaire that assesses the frequency and severity of five clusters of symptoms reflective of executive dysfunction reported by individuals with ADHD. Participants are asked to rate the frequency and severity of a symptom on a scale from 0 to 3, with 0 meaning that the problem described does not relate to them and 3 indicating that the problem is very true for them and occurs almost daily. The range of severity for the total BADDS score is 0 to 120, with scores of 55 and above being consistent with full-syndrome ADHD.
次要结局
- Penn Continuous Performance Test(Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks))
- NYU Paragraph Recall Task(Baseline, end of first Intervention (4 weeks) and end of second Intervention (4 weeks))