LDX and Functional Magnetic Resonance Imaging (fMRI in Menopausal Women
Condition: Menopause; Brain Activity; Cognition
Intervention: Lisdexamfetamine; Placebo
Intervention description: 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.; To assess the effects of a placebo pill on brain activation patterns during tasks of sustained attention and working memory in menopausal women.
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 18.0
Sex: Female
Minimum age: 45 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Menopause; fMRI; Vyvanse

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. 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;

          2. Are within 5 years of last menstrual period (LMP);

          3. Have a follicular stimulating hormone level (FSH) of 20 IU/ml;

          4. Are able to give written informed consent;

          5. Must have clear urine toxicology screen upon recruitment;

          6. Are fluent in written and spoken English;

          7. Are right-handed;

          8. Negative urine pregnancy test if still menstruating.

        Exclusion Criteria:

          1. Mini-mental status exam score of less than or equal to 24;

          2. 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;

          3. Lifetime history of drug addiction or abuse, except nicotine;

          4. Regular use of other psychotropic medication;

          5. Regular use (more than once a week) of alcohol that is less than 3 drinks/day;

          6. 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;

          7. History of seizures;

          8. History of cardiac disease including known cardiac defect or conduction abnormality;

          9. Abnormal electrocardiogram during screening;

         10. Use of estrogen therapy within previous 2 months;

         11. Current pregnancy or planning to become pregnant;

         12. Metallic implant;

         13. Claustrophobia.