LDX and Functional Magnetic Resonance Imaging (fMRI in Menopausal Women
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Utilizing fMRI to Determine the Effects of Vyvanse® on Memory, Attention, and Brain Activity in Menopausal Women|
- Effects of LDX on brain activation during tasks of sustained attention and working memory [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]To assess the effects of LDX on gamma aminobutyric acid (GABA) and glutamate levels as well as brain activation patterns in the prefrontal cortex (PFC) of menopausal aged women during tasks that utilize working memory and sustained attention. Cognitive domains such as attention, concentration, organization, planning, working memory, initiation of appropriate actions and inhibition of inappropriate actions are considered executive functions. This study will assess the extent to which GABA levels and brain activation patterns in menopausal women differ when treated with LDX versus placebo. We will consider these findings in light of the literature regarding stimulant treatment effects on brain activation in adults with attention deficit hyperactivity disorder (ADHD).
- Effects of LDX on performance of cognitive tasks [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]To assess the extent to which the effects of LDX on brain activation patterns are correlated with improvement in cognitive symptoms as reported by Brown Attention Deficit disorder (BADDS) scores and performance on cognitive tests measuring memory and sustained attention.
|Study Start Date:||December 2011|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Lisdexamfetamine
Lisdexamfetamine or Vyvanse
The overall objective of this study is to assess the effects of LDX on brain activation patterns during tasks of sustained attention and working memory in menopausal women.
Other Name: Vyvanse®
Placebo Comparator: Sugar Pill
Placebo pill, capsules
Please refer to this study by its ClinicalTrials.gov identifier: NCT01977625
|United States, Pennsylvania|
|University of Pennsylvania, Penn Center for Womens Behavioral Wellness|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||C. Neill Epperson, M.D.||University of Pennsylvania|