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IMPRES - Improving Memory after RRSO

IMPRES - Improving Memory after RRSO

Clinicaltrials.gov identifier:
NCT03187353

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

Study Contact Information:

The study is being conducted by researchers at the University of Pennsylvania. Contact Brianna Soreth, Research Coordinator by phone at (215) 573-9695 or by email.


IMProving Executive function Study

About the Study

Dr. C. Neill Epperson and her research team at the Penn Center for Women's Behavioral Wellness are studying the effects of a stimulant medication called Vyvanse® on memory and attention in women who had surgery to remove their ovaries to lower their risk for ovarian cancer (risk-reducing salpingo-oophorectomy or RRSO).

Read our blog that includes an interview with a study participant. 

NOTE: This study has been changed to a completely remote clinical trial, so travel is no longer required for this study. These changes went into effect in September of 2020.

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

  • Screening visit in-office at the University of Pennsylvania or remotely (via video chat).
  • Baseline (pre-treatment), includes cognitive testing and questionnaires remotely
  • 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 cognitive testing and questionnaires. 
  • After a 2 week period of no study 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 a last round of cognitive testing and questionnaires.  

Participants will be compensated for their time participating in the study. Total compensation is up to $500. 

All visits can be completed remotely.

If you are interested in participating in this study, you can take our pre-screening survey online here: https://is.gd/impresstudy

Study Lead Investigator

Neill Epperson, MD: neill.epperson@ucdenver.edu

Susan Domchek, MD.

Study Site

  • Philadelphia, PA: University of Pennsylvania
    • Contact Brianna Soreth, Research Coordinator by phone at (215) 573-9695 or by email.
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 surgically-induced menopause 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

 

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
  • those treated with chemotherapy/radiation within the past year