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LDX for the Treatment of Cognitive Functioning Issues in Women Post-Oophorectomy (LDX)

Primary Purpose

Cognitive Impairments, RRSO

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
lisdexamfetamine
Placebo
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Impairments focused on measuring cognitive complains, RRSO, oophorectomy, memory, cognition, early menopause

Eligibility Criteria

30 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female;
  • Age 30-60;
  • Have undergone surgically-induced menopause by oophorectomy or chemically-induced menopause within the previous 10 years;
  • Have at least moderate executive functioning difficulties as evidenced by a score of 25 on the BADDS;
  • Have no history of a DSM-IV psychiatric disorder within the previous year or substance dependence disorder within the previous 5 years (psychostimulant abuse lifetime history), according to the Structured Clinical Interview for Diagnosis-DSM-IV (SCID)-Non-Patient Version;
  • Subject has history of substance abuse disorders (this includes alcohol, prescription, and illicit substances) 3 years ago but the period of abuse did not last more than 5 years according to the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-NP);
  • Are able to give written informed consent (obtained at screening visit);
  • Must have clear urine toxicology screen upon recruitment;
  • Are fluent in written and spoken English;
  • Are right-handed.

Exclusion Criteria:

  • Mini-mental status exam score of 24;
  • Presence of a psychiatric disorder within previous year or a life time history of ADHD or psychotic disorder including bipolar disorder, schizoaffective disorder and schizophrenia;
  • Lifetime history of drug addiction or abuse, except nicotine; 4. Regular use of psychotropic medication except for a selective serotonin reuptake inhibitor or serotonin/norepinephrine reuptake inhibitor or standard sleep medication at a stable dose for at least one month prior to enrollment;
  • Regular use (more than once a week) of alcohol that is 3 drinks/day;
  • Presence of a contraindication to treatment with stimulant medication; this would include the presence of controlled or uncontrolled hypertension, coronary disease, atrial fibrillation, and arrhythmia;
  • History of seizures;
  • History of cardiac disease including known cardiac defect or conduction abnormality;
  • Abnormal electrocardiogram during screening;
  • Presence of a metallic implant;
  • Claustrophobia.

Sites / Locations

  • Penn Center for Women's Behavioral Wellness

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 10 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 8-10 weeks.

Outcomes

Primary Outcome Measures

BADDS Score
To determine whether treatment with LDX improves self-reported executive function (EF) as measured with the BADDS

Secondary Outcome Measures

Brain Activation
To determine the impact of LDX on brain activation in the brain during a working memory task.

Full Information

First Posted
October 30, 2013
Last Updated
September 15, 2017
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT01986777
Brief Title
LDX for the Treatment of Cognitive Functioning Issues in Women Post-Oophorectomy
Acronym
LDX
Official Title
LDX in the Treatment of Executive Function Difficulties in Women After Oophorectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Funding not obtained
Study Start Date
July 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a double-blind, placebo-controlled, study testing whether LDX improves cognitive function and EF in 20 postmenopausal women who report onset of cognitive difficulties after oophorectomy (with or without subsequent chemo/adjunctive therapy). Brain imaging is included at critical time points to obtain objective data regarding effects of LDX as well as potential predictors of resilience in the face of oophorectomy.
Detailed Description
Participants will be asked to undergo three brain-imaging scans throughout the course of the study. Once they are deemed eligible for participation based on two assessment visits, they will be scheduled for their baseline test day. On this they, they will be asked to under a series of cognitive tests following by a brain-imaging scan. They will then take the first dose of either the LDX or placebo, wait for 3 hours and then undergo another brain-imaging scan to assess acute changes to memory/cognition due to the study drug. They will then come in for three 30-minute check-in visits during weeks 2, 4 and 6 on the study drug. They will be asked to undergo a final scan and series of cognitive tasks during weeks 8-10 on the study drug. They will then be discharged from active study participation. All participants, regardless of randomization, will be offered a consultation with the study MD and optional prescription for 4-weeks of treatment with LDX.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairments, RRSO
Keywords
cognitive complains, RRSO, oophorectomy, memory, cognition, early menopause

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lisdexamfetamine
Arm Type
Active Comparator
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 10 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 8-10 weeks.
Intervention Type
Drug
Intervention Name(s)
lisdexamfetamine
Other Intervention Name(s)
Vyvanse
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The placebo capsules will be filled with lactose.
Primary Outcome Measure Information:
Title
BADDS Score
Description
To determine whether treatment with LDX improves self-reported executive function (EF) as measured with the BADDS
Time Frame
8-10 weeks
Secondary Outcome Measure Information:
Title
Brain Activation
Description
To determine the impact of LDX on brain activation in the brain during a working memory task.
Time Frame
8-10 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Female; Age 30-60; Have undergone surgically-induced menopause by oophorectomy or chemically-induced menopause within the previous 10 years; Have at least moderate executive functioning difficulties as evidenced by a score of 25 on the BADDS; Have no history of a DSM-IV psychiatric disorder within the previous year or substance dependence disorder within the previous 5 years (psychostimulant abuse lifetime history), according to the Structured Clinical Interview for Diagnosis-DSM-IV (SCID)-Non-Patient Version; Subject has history of substance abuse disorders (this includes alcohol, prescription, and illicit substances) 3 years ago but the period of abuse did not last more than 5 years according to the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-NP); Are able to give written informed consent (obtained at screening visit); Must have clear urine toxicology screen upon recruitment; Are fluent in written and spoken English; Are right-handed. Exclusion Criteria: Mini-mental status exam score of 24; Presence of a psychiatric disorder within previous year or a life time history of ADHD or psychotic disorder including bipolar disorder, schizoaffective disorder and schizophrenia; Lifetime history of drug addiction or abuse, except nicotine; 4. Regular use of psychotropic medication except for a selective serotonin reuptake inhibitor or serotonin/norepinephrine reuptake inhibitor or standard sleep medication at a stable dose for at least one month prior to enrollment; Regular use (more than once a week) of alcohol that is 3 drinks/day; Presence of a contraindication to treatment with stimulant medication; this would include the presence of controlled or uncontrolled hypertension, coronary disease, atrial fibrillation, and arrhythmia; History of seizures; History of cardiac disease including known cardiac defect or conduction abnormality; Abnormal electrocardiogram during screening; Presence of a metallic implant; Claustrophobia.
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
Penn Center for Women's Behavioral Wellness
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Study has been withdrawn

Learn more about this trial

LDX for the Treatment of Cognitive Functioning Issues in Women Post-Oophorectomy

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