LDX and Functional Magnetic Resonance Imaging (fMRI in Menopausal Women

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Utilizing fMRI to Determine the Effects of Vyvanse® on Memory, Attention, and Brain Activity in Menopausal Women

Conditions
-----------------
Menopause, Brain Activity, Cognition

Intervention / Treatment
-----------------
* Drug: Lisdexamfetamine
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have no previous or present history of a DSM-IV psychiatric or substance dependence disorder within the previous year, according to the Structured Clinical Interview for Diagnosis- DSM-IV (SCID)-Non-Patient Version; Are within 5 years of last menstrual period (LMP); Have a follicular stimulating hormone level (FSH) of 20 IU/ml; Are able to give written informed consent; Must have clear urine toxicology screen upon recruitment; Are fluent in written and spoken English; Are right-handed; Negative urine pregnancy test if still menstruating. Exclusion Criteria: Mini-mental status exam score of less than or equal to 24; Presence of a psychiatric disorder within previous year or a life time history of ADHD or psychotic disorder including bipolar disorder, schizoaffective disorder, and schizophrenia; Lifetime history of drug addiction or abuse, except nicotine; Regular use of other psychotropic medication; Regular use (more than once a week) of alcohol that is less than 3 drinks/day; Presence of a contraindication to treatment with stimulant medication unless the condition is controlled with medication; this would include the presence of uncontrolled hypertension, coronary disease, atrial fibrillation, and arrhythmia; History of seizures; History of cardiac disease including known cardiac defect or conduction abnormality; Abnormal electrocardiogram during screening; Use of estrogen therapy within previous 2 months; Current pregnancy or planning to become pregnant; Metallic implant; Claustrophobia.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lisdexamfetamine<br>Lisdexamfetamine or Vyvanse | Drug: Lisdexamfetamine<br>* 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.<br>* Other names: Vyvanse®;|
| Placebo Comparator: Sugar Pill<br>Placebo pill, capsules | Other: Placebo<br>* To assess the effects of a placebo pill on brain activation patterns during tasks of sustained attention and working memory in menopausal women.<br>* Other names: Sugar pill;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Blood Oxygen Level Dependent (BOLD) Signal | 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. | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in BADDS Total Score | 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. | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fMRI, Menopause, Vyvanse