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IMProving Executive function Study

This study is open to:

Women who are eligible to participate in the study include:

  • women between the ages of 35 and 55
  • have undergone surgery to reduce their risk for breast, ovarian or other gynecologic cancers within the last 15 years and were premenopausal at the time of surgery
  • women with executive function complaints
  • women must be willing to travel to University of Pennsylvania for required in-office visits and imaging. 

 

This study is not open to:

Women who are not eligible:

  • women with current, untreated psychiatric disorder
  • lifetime history of ADHD or psychotic disorder
  • lifetime history of stimulant abuse or dependence
  • claustrophobia
  • presence of metallic implants
  • women who have been diagnosed with ovarian cancer
IMProving Executive function Study

IMPRES - Improving Memory after RRSO

Clinicaltrials.gov identifier:
NCT03187353

Quality of Life:
Breast Cancer Survivor
High Risk But No Cancer

Study Contact Information

The study is being conducted by researchers at the University of Pennsylvania. Contact Emily Lipner, Research Coordinator by phone at (215) 573-8873 or by email.

About the Study

Dr. C. Neill Epperson and her research team at the Penn Center for Women's Behavioral Wellness are seeking women to help study the effects of a stimulant medication called Vyvanse ┬« on memory and attention in women who underwent surgically-induced menopause via risk-reducing salpingo-oophorectomy (RRSO).

Type of Study

This is a 2-arm, double-blind, randomized, placebo controled, cross-over study. 

  • This is a randomized study, meaning that participants will be placed into one of the two treatment groups by chance. Neither patients nor the research doctor will choose the group participants are placed in. 
  • This is a double-blind study, neither the patient in the study nor their doctor will know which group they have been assigned to. 
  • The study has two arms. This means that patients in the study are placed in one of two different groups. One group will received the drug Vyvanse┬« and the other group will receive a placebo. After 6 weeks of treatment, patients will cross over to the other arm of the study. 
  • This is a crossover study. This means that in the second half of the study, patients who began in the placebo arm will be placed on the drug Vyvanse, and patients who began on Vyvanse will be placed on a placebo

What the Study Entails

Participants who meet initial criteria and enroll will follow this schedule:

  • On enrollment they will undergo a 4-hour, in-office screening appointment at University of Pennsylvania. 
  • Pre-treatment brain MRI.
  • Randomized to one of two arms. One group will receive Vyvanse for six weeks and the other group will receive a placebo for six weeks. 
  • After a 6-week course of treatment, participants will undergo another brain MRI
  • After a 2 week period of no medication, participants will cross over to the other arm of the study. Women who received six weeks of placebo will receive Vyvanse. Women who received Vyvanse will switch to receiving a placebo
  •  Upon finishing the second 6-week course of treatment, participants will undergo another brain scan. 

Participants will be compensated for their time participating in the study. Total compensation is up to $650. 

Study Lead Investigator

Neill Epperson, MD: cepp@mail.med.upenn.edu

Susan Domchek, MD.

Study Site

  • Philadelphia, PA: University of Pennsylvania
    • Contact Emily Lipner, Research Coordinator by phone at (215) 573-8873 or by email

 

 

 

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