Overview

LDX and Functional Magnetic Resonance Imaging (fMRI in Menopausal Women

Status:
Completed

Trial end date:
2014-04-01

Target enrollment:
0

Participant gender:
Female

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

University of Pennsylvania

Collaborator:

Shire

Treatments:

Lisdexamfetamine Dimesylate

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.