Brain Activity, Cognition, Menopause
Conditions
Keywords
Menopause, fMRI, Vyvanse
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.
Interventions
DRUGLisdexamfetamine
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.
OTHERPlacebo
To assess the effects of a placebo pill on brain activation patterns during tasks of sustained attention and working memory in menopausal women.
Sponsors
Shire
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
45 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Blood Oxygen Level Dependent (BOLD) Signal | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in BADDS Total Score | 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. |
Countries
United States
Participant flow
Recruitment details
18 participants were recruited from the parent study NCT01324024 to complete 3 brain imaging scans.
Pre-assignment details
Of the 18 participants who were recruited, they all were deemed eligible based on the criteria for the parent study NCT01324024. In addition, they must have been deemed eligible to undergo a functional brain imaging scan. Of these 18 participants, 14 completed all 3 scans.
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants first received titrated doses of Lisdexamfetamine 20 to 60 mg/d each day for 4 weeks followed by a 2-week washout, then they received Placebo tablets (matching Lisdexamfetamine tablets) each day for 4 weeks. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (4 Weeks) | Withdrawal by Subject | 3 | 0 |
| Second Intervention (4 Weeks) | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age, Continuous | 53.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 15 | 1 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
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.
Time frame: 10 weeks
Population: All participants who completed all phases of the study were included in the outcome analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine | Percent Change in Blood Oxygen Level Dependent (BOLD) Signal | 0.41 percent change | Standard Deviation 0.65 |
| Placebo | Percent Change in Blood Oxygen Level Dependent (BOLD) Signal | -0.11 percent change | Standard Deviation 0.46 |
Secondary
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.
Time frame: 10 weeks
Population: Participants who completed all 3 scans.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lisdexamfetamine | Change in BADDS Total Score | -23.36 change in units | Standard Deviation 11.57 |
| Placebo | Change in BADDS Total Score | -8.57 change in units | Standard Deviation 12.51 |