LDX and Functional Magnetic Resonance Imaging (fMRI in Menopausal Women

University of Pennsylvania

Status and phase: Completed; Phase 4

Conditions: Menopause; Brain Activity; Cognition

Treatments: Drug: Lisdexamfetamine; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01977625

814735

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: Female

Ages: 45 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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18 participants in 2 patient groups, including a placebo group

Lisdexamfetamine

Active Comparator group

Description:

Lisdexamfetamine or Vyvanse

Treatment:

Drug: Lisdexamfetamine

Sugar Pill

Placebo Comparator group

Description:

Placebo pill, capsules

Treatment:

Other: Placebo