Phase 4
N=18
LDX and Functional Magnetic Resonance Imaging (fMRI in Menopausal Women
Menopause · Brain Activity · Cognition
Bottom Line
View on ClinicalTrials.gov: NCT01977625 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Percent Change in Blood Oxygen Level Dependent (BOLD) Signal — 0.41; -0.11 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lisdexamfetamine (Drug); Placebo (Other)
- Age
- Adult · 45+ yrs
- Sex
- Female
- Sponsor
- University of Pennsylvania
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Blood Oxygen Level Dependent (BOLD) Signal |
0.41; -0.11 | — |
| SECONDARY Change in BADDS Total Score |
-23.36; -8.57 | — |
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
- 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.
Data sourced from ClinicalTrials.gov (NCT01977625). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.