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IMProving Executive Function Study (IMPRES)

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ClinicalTrials.gov Identifier: NCT03187353
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : December 12, 2018
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief 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.

Condition or disease Intervention/treatment Phase
Cognitive Impairment RRSO Drug: Lisdexamfetamine Drug: Placebo oral capsule Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multi-Modal Imaging of Psychostimulant Effects on Executive Function Post-RRSO
Actual Study Start Date : September 22, 2017
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Lisdexamfetamine
Participants will have a 50% chance of receiving the active study medication. They will begin at 20 mg/d and will increase up to 60 mg/d after 4 weeks, if well tolerated. Total time on the study drug is up to 6 weeks.
Drug: Lisdexamfetamine
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.
Other Name: Vyvanse

Placebo Comparator: Placebo
Participants will have a 50% chance of receiving the placebo for this study. They will begin with 1 sugar pill and will increase up to 3 pills after 4 weeks. Maximum time for taking the placebo is 6 weeks.
Drug: Placebo oral capsule
The placebo capsule will be filled with microcellulose.
Other Name: sugar pill




Primary Outcome Measures :
  1. Brown Attention Deficit Disorder Scale (BADDS) Score [ Time Frame: 6 weeks ]
    To subjectively determine whether treatment with LDX improves self-reported executive function (EF) via the BADDS


Secondary Outcome Measures :
  1. Brain activation [ Time Frame: 6 weeks ]
    To objectively determine the impact of LDX on executive system activation during a working memory task via proton magnetic resonance spectroscopy (1H-MRS) and functional magnetic resonance imaging (fMRI)



Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 58 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03187353


Contacts
Contact: Stephanie N Criniti, MS 215-573-9695 scriniti@pennmedicine.upenn.edu

Locations
United States, Pennsylvania
3535 Market Street Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Stephanie Criniti, MS    215-573-9695    scriniti@pennmedicine.upenn.edunn.edu   
Contact: Cynthia Neill Epperson, MD    215-573-8871    cepp@mail.med.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: C. Neill Epperson, MD University of Pennsylvania

Additional Information:
Publications:
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03187353     History of Changes
Other Study ID Numbers: 826981
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: December 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by University of Pennsylvania:
Cognitive complaints
RRSO
Oophorectomy
Memory
Cognition
Early menopause

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Lisdexamfetamine Dimesylate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents