Ignite Creation Date:
2024-05-06 @ 10:10 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03187353
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2017-06-12
Brief Title:
IMProving Executive Function Study
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Multi-Modal Imaging of Psychostimulant Effects on Executive Function Post-RRSO
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPRES
Brief Summary:
This is a double-blind placebo-controlled crossover study testing whether Vyvanse lisdexamfetamine LDX improves executive functioning EF in 100 postmenopausal women who report onset of EF difficulties after oophorectomy 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
UPDATE We have recently updated this protocol 092020 to offer a remote version of the study that can be completed entirely from the participants home This alternate version of the study eliminates travel the MRI and blood draws
UPDATE We have recently updated this protocol 092020 to offer a remote version of the study that can be completed entirely from the participants home This alternate version of the study eliminates travel the MRI and blood draws
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None