IMProving Executive Function Study
Condition: Cognitive Impairment; RRSO
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a double-blind, placebo-controlled, crossover study testing whether Vyvanse
      (lisdexamfetamine; LDX) improves executive functioning (EF) in 100 postmenopausal women who
      report onset of EF difficulties after oophorectomy. This study involves magnetic resonance
      imaging (MRI) to see how LDX affects brain chemistry while undergoing two 6-week trials of
      the study drug and placebo capsules.

      UPDATE: We have recently updated this protocol (09/2020) to offer a remote version of the
      study that can be completed entirely from the participant's home. This alternate version of
      the study eliminates travel, the MRI, and blood draws.
    

Detailed description: 
      Following a medically induced menopause, many women report difficulty in remembering things,
      focusing and concentrating. The purpose of this study is to examine the effects of a
      stimulant medication called Vyvanse® (lisdexamfetamine; LDX) on executive functioning, such
      as attention, processing, organization, and memory, in women who are experiencing executive
      functioning difficulties after having undergone a risk-reducing bilateral
      salpingo-oophorectomy (RRSO). This study involves magnetic resonance imaging (MRI) to see how
      LDX affects brain chemistry while undergoing two 6-week trials of the study drug and placebo
      capsules.

      Individuals wishing to participate in this study are medically healthy women between the ages
      of 35-58 years old who have undergone a risk-reducing bilateral salpingo-oophorectomy (RRSO)
      within the previous 15 years. Participants must have been premenopausal before undergoing
      RRSO (meaning they were having regular periods). They also must not have undergone radiation
      or chemotherapy in the past year.

      Furthermore, participants must not suffer from a mental illness, including Attention Deficit
      Hyperactivity Disorder (ADHD), and must not have a recent history of drug abuse.
      Additionally, participants must not suffer from a fear of small, enclosed spaces
      (claustrophobia), and not have any implanted medical devices such as a pacemaker, orthodontic
      braces, or shrapnel. They must not have a history of seizures, uncontrolled hypertension or
      known renal impairment.
    

Intervention name(s): Lisdexamfetamine; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Stimulant medications are used to reduce interruptive behavior, fidgeting, and other hyperactive symptoms, as well as help a person finish tasks and improve his or her relationships for adults who have ADHD. Please note that the FDA has not approved the use of Vyvanse® for the treatment of memory and concentration difficulties related to medically induced menopause.; The placebo capsule will be filled with microcellulose.
Other intervention name(s): Vyvanse; sugar pill
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cognitive complaints; RRSO; Oophorectomy; Memory; Cognition; Early menopause