IMProving Executive Function Study
Condition: Cognitive Impairment; RRSO
MeSH terms: Cognitive Dysfunction
Intervention: Lisdexamfetamine; Placebo oral capsule
Intervention description: 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.
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 69.0
Sex: Female
Minimum age: 35 Years
Maximum age: 58 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Cognitive complaints; RRSO; Oophorectomy; Memory; Cognition; Early menopause

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female;

          -  Age 35-58;

          -  Have undergone risk-reducing bilateral salpingo-oophorectomy (RRSO) within the
             previous 15 years AND were premenopausal at the time of RRSO;

          -  Score of ≥ 20 on the Brown Attention Deficit Disorder Scale (BADDS);

          -  Onset of executive function difficulties occurred post RRSO;

          -  Clean urine drug screen (nicotine and marijuana are permissible);

          -  Are fluent in written and spoken English;

          -  Are able to give written informed consent (obtained at screening visit);

          -  Have a high school diploma or equivalent degree (i.e., GED), as per subject report;

          -  If using aromatase inhibitors or tamoxifen: Must have been on a stable dose for at
             least 6 months;

          -  If completing visits remotely: Must have access to a telecommunications application
             (i.e., Skype), email, scanner/fax machine, and a private area that enables the
             protection of participant confidentiality.

        Exclusion criteria:

          -  Current, untreated psychiatric disorder;

          -  Substance use disorder within the previous 3 years;

          -  Lifetime history of ADHD or psychotic disorder including bipolar disorder,
             schizoaffective disorder, and schizophrenia;

          -  Lifetime history of stimulant abuse or dependence;

          -  Regular use of psychotropic medications except selective serotonin reuptake inhibitors
             (SSRI), serotonin noradrenergic reuptake inhibitors (SNRI), bupropion, zolpidem,
             gabapentin, or buspirone;

          -  Chemotherapy within the past year;

          -  Previous history of sensitivity or adverse reaction to lisdexamfetamine (LDX);

          -  History of seizures or unstable medical condition;

          -  Known heart disease or clinically significant abnormal electrocardiogram during
             screening as determined by the study MD;

          -  Uncontrolled hypertension;

          -  Presence of a metallic implant contraindicative to scanning at the 7T level;

          -  Claustrophobia.

          -  Consistent systolic blood pressure of >145mm Hg or diastolic blood pressure >90 mm Hg
             after three readings at time of screening;

          -  Known renal impairment and End Stage Renal Disease (ESRD).