IMProving Executive Function Study
关键词
抽象
描述
Following a medically induced menopause, many women report difficulty in remembering things, focusing and concentrating. The purpose of this study is to examine the effects of a stimulant medication called Vyvanse® (lisdexamfetamine; LDX) on executive functioning, such as attention, processing, organization, and memory, in women who are experiencing executive functioning difficulties after having undergone a risk-reducing bilateral salpingo-oophorectomy (RRSO). This study involves magnetic resonance imaging (MRI) to see how LDX affects brain chemistry while undergoing two 6-week trials of the study drug and placebo capsules.
Individuals wishing to participate in this study are medically healthy women between the ages of 35-58 years old who have undergone a risk-reducing bilateral salpingo-oophorectomy (RRSO) within the previous 15 years. Participants must have been premenopausal before undergoing RRSO (meaning they were having regular periods). They also must not have undergone radiation or chemotherapy in the past year.
Furthermore, participants must not suffer from a mental illness, including Attention Deficit Hyperactivity Disorder (ADHD), and must not have a recent history of drug abuse. Additionally, participants must not suffer from a fear of small, enclosed spaces (claustrophobia), and not have any implanted medical devices such as a pacemaker, orthodontic braces, or shrapnel. They must not have a history of seizures, uncontrolled hypertension or known renal impairment.
日期
| 最后验证: | 12/31/2019 |
| 首次提交: | 06/11/2017 |
| 提交的预估入学人数: | 06/11/2017 |
| 首次发布: | 06/13/2017 |
| 上次提交的更新: | 01/07/2020 |
| 最近更新发布: | 01/09/2020 |
| 实际学习开始日期: | 09/21/2017 |
| 预计主要完成日期: | 06/30/2022 |
| 预计完成日期: | 06/30/2022 |
状况或疾病
干预/治疗
Drug: Lisdexamfetamine
Drug: Placebo
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Lisdexamfetamine Participants will have a 50% chance of receiving the active study medication. They will begin at 20 mg/d and will increase up to 60 mg/d after 4 weeks, if well tolerated. Total time on the study drug is up to 6 weeks. | Drug: Lisdexamfetamine Stimulant medications are used to reduce interruptive behavior, fidgeting, and other hyperactive symptoms, as well as help a person finish tasks and improve his or her relationships for adults who have ADHD. Please note that the FDA has not approved the use of Vyvanse® for the treatment of memory and concentration difficulties related to medically induced menopause. |
| Placebo Comparator: Placebo Participants will have a 50% chance of receiving the placebo for this study. They will begin with 1 sugar pill and will increase up to 3 pills after 4 weeks. Maximum time for taking the placebo is 6 weeks. | Drug: Placebo The placebo capsule will be filled with microcellulose. |
资格标准
| 有资格学习的年龄 | 35 Years 至 35 Years |
| 有资格学习的性别 | Female |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Female; - Age 35-58; - Have undergone risk-reducing bilateral salpingo-oophorectomy (RRSO) within the previous 15 years AND were premenopausal at the time of RRSO; - Score of ≥ 20 on the Brown Attention Deficit Disorder Scale (BADDS); - Onset of executive function difficulties occurred post RRSO; - Clean urine drug screen (nicotine and marijuana are permissible); - Are fluent in written and spoken English; - Are able to give written informed consent (obtained at screening visit); - Have a high school diploma or equivalent degree (i.e., GED), as per subject report; - If using aromatase inhibitors or tamoxifen: Must have been on a stable dose for at least 6 months; - If completing visits remotely: Must have access to a telecommunications application (i.e., Skype), email, scanner/fax machine, and a private area that enables the protection of participant confidentiality. Exclusion criteria: - Current, untreated psychiatric disorder; - Substance use disorder within the previous 3 years; - Lifetime history of ADHD or psychotic disorder including bipolar disorder, schizoaffective disorder, and schizophrenia; - Lifetime history of stimulant abuse or dependence; - Regular use of psychotropic medications except selective serotonin reuptake inhibitors (SSRI), serotonin noradrenergic reuptake inhibitors (SNRI), bupropion, zolpidem, gabapentin, or buspirone; - Chemotherapy within the past year; - Previous history of sensitivity or adverse reaction to lisdexamfetamine (LDX); - History of seizures or unstable medical condition; - Known heart disease or clinically significant abnormal electrocardiogram during screening as determined by the study MD; - Uncontrolled hypertension; - Presence of a metallic implant contraindicative to scanning at the 7T level; - Claustrophobia. - Consistent systolic blood pressure of >145mm Hg or diastolic blood pressure >90 mm Hg after three readings at time of screening; - Known renal impairment and End Stage Renal Disease (ESRD). |
结果
主要结果指标
1. Brown Attention Deficit Disorder Scale (BADDS) Score [6 weeks]
次要成果指标
1. Brain activation [6 weeks]
