LDX and Functional Magnetic Resonance Imaging (fMRI in Menopausal Women
Status: | Completed |
---|---|
Conditions: | Cognitive Studies, Cognitive Studies, Women's Studies |
Therapuetic Areas: | Psychiatry / Psychology, Reproductive |
Healthy: | No |
Age Range: | 45 - 60 |
Updated: | 7/29/2018 |
Start Date: | December 2011 |
End Date: | April 2014 |
Utilizing fMRI to Determine the Effects of Vyvanse® on Memory, Attention, and Brain Activity 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.
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.
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.
We found this trial at
1
site
Philadelphia, Pennsylvania 19104
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