LDX and Functional Magnetic Resonance Imaging (fMRI in Menopausal Women

Phase 4

Completed

• Conditions: Menopause; Brain Activity; Cognition
• Interventions: Other: Placebo; Drug: Lisdexamfetamine

• Registration Number: NCT01977625
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-10-30
• Study First Posted: 2013-11-06
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Results First Submitted: 2016-09-08
• Results First Submitted QC: 2017-06-08
• Status Verified: 2017-07
• Results First Posted: 2017-07-11
• Last Update Submitted: 2018-07-25
• Last Update Posted: 2018-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sugar Pill	Placebo	Placebo pill, capsules
Lisdexamfetamine	Lisdexamfetamine	Lisdexamfetamine or Vyvanse

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Pennsylvania, Penn Center for Womens Behavioral Wellness; 🇺🇸 Philadelphia, Pennsylvania, United States