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IMProving Executive Function Study (IMPRES)

This study is currently recruiting participants.
Verified September 2017 by University of Pennsylvania
Sponsor:
ClinicalTrials.gov Identifier:
NCT03187353
First Posted: June 14, 2017
Last Update Posted: September 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Pennsylvania
June 12, 2017
June 14, 2017
September 26, 2017
September 22, 2017
July 1, 2022   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT03187353 on ClinicalTrials.gov Archive Site
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)
Same as current
Not Provided
Not Provided
 
IMProving Executive Function Study
Multi-Modal Imaging of Psychostimulant Effects on Executive Function Post-RRSO
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.

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 35-55 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 at any point before or after your RRSO.

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 also be right-handed, 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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Cognitive Impairment
  • RRSO
  • 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
  • Drug: Placebo oral capsule
    The placebo capsule will be filled with microcellulose.
    Other Name: sugar pill
  • 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.
    Intervention: Drug: Lisdexamfetamine
  • 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.
    Intervention: Drug: Placebo oral capsule

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
July 1, 2022
July 1, 2022   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female;
  • Age 35-55;
  • 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;
  • Right-handed;
  • Are fluent in written and spoken English;
  • Are able to give written informed consent (obtained at screening visit);
  • Have an Intelligence Quotient of at least 90 as per the Wechsler Abbreviated Scale of Intelligence (WASI) assessment.

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 or gabapentin;
  • Current use of aromatase inhibitors or chemotherapies (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; 10. Uncontrolled hypertension; 11. Presence of a metallic implant contraindicative to scanning at the 7T level; 11. Claustrophobia. 12. Consistent systolic blood pressure of >145mm Hg or diastolic blood pressure >90 mm Hg after three readings at time of screening; 13. Known renal impairment and End Stage Renal Disease (ESRD).
Sexes Eligible for Study: Female
35 Years to 55 Years   (Adult)
Yes
Contact: Emily A Lipner, BA 215-573-8873 lipnere@mail.med.upenn.edu
Contact: Claudia J Iannelli, MS 215-417-8839 sclaud@mail.med.upenn.edu
United States
 
 
NCT03187353
826981
Yes
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
Plan to Share IPD: Undecided
University of Pennsylvania
University of Pennsylvania
Not Provided
Principal Investigator: C. Neill Epperson, MD University of Pennsylvania
University of Pennsylvania
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP