LDX and Functional Magnetic Resonance Imaging (fMRI in Menopausal Women

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.

Study Overview

• Status: Completed
• Conditions: Menopause; Cognition; Brain Activity
• Intervention / Treatment: Drug: Lisdexamfetamine; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania, Penn Center for Womens Behavioral Wellness

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lisdexamfetamine; Lisdexamfetamine or Vyvanse	Drug: Lisdexamfetamine; 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.; Other Names: Vyvanse®
Placebo Comparator: Sugar Pill; Placebo pill, capsules	Other: Placebo; To assess the effects of a placebo pill on brain activation patterns during tasks of sustained attention and working memory in menopausal women.; Other Names: Sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 weeks

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Shire
• Investigators: Principal Investigator: Cynthia Neill Epperson, M.D., University of Pennsylvania

Publications and helpful links

General Publications

• Epperson CN, Pittman B, Czarkowski KA, Bradley J, Quinlan DM, Brown TE. Impact of atomoxetine on subjective attention and memory difficulties in perimenopausal and postmenopausal women. Menopause. 2011 May;18(5):542-8. doi: 10.1097/gme.0b013e3181fcafd6.
• Epperson CN, Shanmugan S, Kim DR, Mathews S, Czarkowski KA, Bradley J, Appleby DH, Iannelli C, Sammel MD, Brown TE. New onset executive function difficulties at menopause: a possible role for lisdexamfetamine. Psychopharmacology (Berl). 2015 Aug;232(16):3091-100. doi: 10.1007/s00213-015-3953-7. Epub 2015 Jun 11.
• Shanmugan S, Loughead J, Nanga RP, Elliott M, Hariharan H, Appleby D, Kim D, Ruparel K, Reddy R, Brown TE, Epperson CN. Lisdexamfetamine Effects on Executive Activation and Neurochemistry in Menopausal Women with Executive Function Difficulties. Neuropsychopharmacology. 2017 Jan;42(2):437-445. doi: 10.1038/npp.2016.162. Epub 2016 Aug 23.

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: October 30, 2013
• First Submitted That Met QC Criteria: October 30, 2013
• First Posted (Estimate): November 6, 2013

Study Record Updates

• Last Update Posted (Actual): July 27, 2018
• Last Update Submitted That Met QC Criteria: July 25, 2018
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Menopause; fMRI; Vyvanse
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Lisdexamfetamine Dimesylate
• Other Study ID Numbers: 814735

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO