Utilizing fMRI to Determine the Effects of Vyvanse® on Memory, Attention, and Brain Activity in Menopausal Women
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Percent Change in Blood Oxygen Level Dependent (BOLD) Signal
研究概览
简要总结
This study seeks to assess the effects of lisdexamfetamine (trademark name: Vyvanse; LDX) on executive function and prefrontal cortex activation in menopausal women ages 45-57, who report subjective cognitive difficulties. This protocol will recruit women from Dr. Epperson's ongoing study, Protocol #812470, to examine the impact of LDX on brain activation during performance of cognitive tasks specifically probing prefrontal cortex function.
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
- Double (Participant, Investigator)
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
- •Have no previous or present history of a DSM-IV psychiatric or substance dependence disorder within the previous year, according to the Structured Clinical Interview for Diagnosis- DSM-IV (SCID)-Non-Patient Version;
- •Are within 5 years of last menstrual period (LMP);
- •Have a follicular stimulating hormone level (FSH) of 20 IU/ml;
- •Are able to give written informed consent;
- •Must have clear urine toxicology screen upon recruitment;
- •Are fluent in written and spoken English;
- •Are right-handed;
- •Negative urine pregnancy test if still menstruating.
排除标准
- •Mini-mental status exam score of less than or equal to 24;
- •Presence of a psychiatric disorder within previous year or a life time history of ADHD or psychotic disorder including bipolar disorder, schizoaffective disorder, and schizophrenia;
- •Lifetime history of drug addiction or abuse, except nicotine;
- •Regular use of other psychotropic medication;
- •Regular use (more than once a week) of alcohol that is less than 3 drinks/day;
- •Presence of a contraindication to treatment with stimulant medication unless the condition is controlled with medication; this would include the presence of uncontrolled hypertension, coronary disease, atrial fibrillation, and arrhythmia;
- •History of seizures;
- •History of cardiac disease including known cardiac defect or conduction abnormality;
- •Abnormal electrocardiogram during screening;
- •Use of estrogen therapy within previous 2 months;
- •Current pregnancy or planning to become pregnant;
- •Metallic implant;
- •Claustrophobia.
研究组 & 干预措施
Lisdexamfetamine
Lisdexamfetamine or Vyvanse
干预措施: Lisdexamfetamine (Drug)
Sugar Pill
Placebo pill, capsules
干预措施: Placebo (Other)
结局指标
主要结局
Percent Change in Blood Oxygen Level Dependent (BOLD) Signal
时间窗: 10 weeks
Blood-oxygen-level dependent contrast imaging, or BOLD-contrast imaging, is a method used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time. BOLD signals were compared from baseline, first intervention and second intervention.
次要结局
- Change in BADDS Total Score(10 weeks)