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IMProving Executive Function Study (IMPRES)

Primary Purpose

Cognitive Impairment, RRSO

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Lisdexamfetamine

Placebo oral capsule

About this trial

This is an interventional treatment trial for Cognitive Impairment focused on measuring Cognitive complaints, RRSO, Oophorectomy, Memory, Cognition, Early menopause

Eligibility Criteria

35 Years - 58 Years (Adult)FemaleAccepts Healthy Volunteers

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).

Sites / Locations

3535 Market Street

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lisdexamfetamine

Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Brown Attention Deficit Disorder Scale (BADDS) Score

To subjectively determine whether treatment with LDX improves self-reported executive function (EF) via the BADDS

Secondary Outcome Measures

Brain activation

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)

Full Information

NCT ID

NCT03187353

First Posted

June 12, 2017

Last Updated

April 28, 2023

Sponsor

University of Pennsylvania

1. Study Identification

Unique Protocol Identification Number

NCT03187353

Brief Title

IMProving Executive Function Study

Acronym

IMPRES

Official Title

Multi-Modal Imaging of Psychostimulant Effects on Executive Function Post-RRSO

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

September 22, 2017 (Actual)

Primary Completion Date

April 30, 2022 (Actual)

Study Completion Date

April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Pennsylvania

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cognitive Impairment, RRSO

Keywords

Cognitive complaints, RRSO, Oophorectomy, Memory, Cognition, Early menopause

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

133 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lisdexamfetamine

Arm Type

Active Comparator

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Lisdexamfetamine

Other Intervention Name(s)

Vyvanse

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.

Intervention Type

Drug

Intervention Name(s)

Placebo oral capsule

Other Intervention Name(s)

sugar pill

Intervention Description

The placebo capsule will be filled with microcellulose.

Primary Outcome Measure Information:

Title

Brown Attention Deficit Disorder Scale (BADDS) Score

Description

To subjectively determine whether treatment with LDX improves self-reported executive function (EF) via the BADDS

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Brain activation

Description

Time Frame

6 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

58 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

C. Neill Epperson, MD

Organizational Affiliation

University of Pennsylvania

Official's Role

Principal Investigator

Facility Information:

Facility Name

3535 Market Street

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

27550732

Citation

Shanmugan S, Loughead J, Nanga RP, Elliott M, Hariharan H, Appleby D, Kim D, Ruparel K, Reddy R, Brown TE, Epperson CN. Lisdexamfetamine Effects on Executive Activation and Neurochemistry in Menopausal Women with Executive Function Difficulties. Neuropsychopharmacology. 2017 Jan;42(2):437-445. doi: 10.1038/npp.2016.162. Epub 2016 Aug 23.

Results Reference

background

PubMed Identifier

26063677

Citation

Epperson CN, Shanmugan S, Kim DR, Mathews S, Czarkowski KA, Bradley J, Appleby DH, Iannelli C, Sammel MD, Brown TE. New onset executive function difficulties at menopause: a possible role for lisdexamfetamine. Psychopharmacology (Berl). 2015 Aug;232(16):3091-100. doi: 10.1007/s00213-015-3953-7. Epub 2015 Jun 11.

Results Reference

background

Links:

URL

http://www.med.upenn.edu/womenswellness/studies.html

Description

Research at the Penn Center for Women's Behavioral Wellness

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IMProving Executive Function Study

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