IMProving Executive Function Study (IMPRES)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03187353|
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : July 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cognitive Impairment RRSO||Drug: Lisdexamfetamine Drug: Placebo oral capsule||Phase 4|
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 at any point before or after your RRSO.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Multi-Modal Imaging of Psychostimulant Effects on Executive Function Post-RRSO|
|Actual Study Start Date :||September 22, 2017|
|Estimated Primary Completion Date :||July 1, 2022|
|Estimated Study Completion Date :||July 1, 2022|
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.
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.
Other Name: Vyvanse
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 oral capsule
The placebo capsule will be filled with microcellulose.
Other Name: sugar pill
- Brown Attention Deficit Disorder Scale (BADDS) Score [ Time Frame: 6 weeks ]To subjectively determine whether treatment with LDX improves self-reported executive function (EF) via the BADDS
- Brain activation [ Time Frame: 6 weeks ]To objectively determine the impact of LDX on executive system activation during a working memory task via proton magnetic resonance spectroscopy (1H-MRS) and functional magnetic resonance imaging (fMRI)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03187353
|Contact: Stephanie N Criniti, MSfirstname.lastname@example.org|
|Contact: Claudia J Iannelli, MSemail@example.com|
|United States, Pennsylvania|
|3535 Market Street||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Emily Lipner 215-573-8873 firstname.lastname@example.org|
|Contact: Cynthia Neill Epperson, MD 215-573-8871 email@example.com|
|Principal Investigator:||C. Neill Epperson, MD||University of Pennsylvania|