LDX and Functional Magnetic Resonance Imaging (fMRI in Menopausal Women
|ClinicalTrials.gov Identifier: NCT01977625|
Recruitment Status : Completed
First Posted : November 6, 2013
Results First Posted : July 11, 2017
Last Update Posted : August 30, 2017
|Condition or disease||Intervention/treatment||Phase|
|Menopause Brain Activity Cognition||Drug: Lisdexamfetamine Other: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Utilizing fMRI to Determine the Effects of Vyvanse® on Memory, Attention, and Brain Activity in Menopausal Women|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
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
To assess the effects of a placebo pill on brain activation patterns during tasks of sustained attention and working memory in menopausal women.
Other Name: Sugar pill
- Percent Change in Blood Oxygen Level Dependent (BOLD) Signal [ Time Frame: 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.
- Change in BADDS Total Score [ Time Frame: 10 weeks ]The total BADDS ranged from 0-120 with higher scores meaning greater problems with memory, attention and focus. Difference in BADDS score from Baseline to End of Treatment for each study Arm was calculated.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01977625
|United States, Pennsylvania|
|University of Pennsylvania, Penn Center for Womens Behavioral Wellness|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Cynthia Neill Epperson, M.D.||University of Pennsylvania|