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E2 and LDX for the Treatment of Cognitive Complaints After Oophorectomy (E2LDX)

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ClinicalTrials.gov Identifier: NCT01986764
Recruitment Status : Withdrawn (Funding was not obtained for this study and no participants were enrolled.)
First Posted : November 18, 2013
Last Update Posted : March 24, 2017
Sponsor:
Information provided by (Responsible Party):
C. Neill Epperson, University of Pennsylvania

Brief Summary:
This project seeks to address cognitive disturbance, which is a frequent adverse sequelae of riskreducing bilateral salpingo-oophorectomy (RRSO) with or without post-procedure chemotherapy and adjunctive treatments. RRSO after completion of childbearing is recommended for prevention of ovarian and breast cancer in women with BRCA1/BRCA2 mutations and standard of care for women with some forms of hormone-responsive cancer. Knowledge regarding the impact of this procedure, with or without chemotherapy, and subsequent hypogonadism on brain health is less than adequate. Premenopausal women who undergo an acute surgical menopause are at greater risk for verbal memory decline and executive function (EF) complaints, but as of yet, we cannot predict who is going to experience these adverse sequelae, nor do we have targeted prevention or treatment strategies other than hormone therapy, which is not an option in many cases and not always effective. An idealized sample as women who are planning for a RRSO will undergo brain imaging and behavioral assessments pre- and post-surgery as well as pre-/post-treatment with E2 or the psychostimulant, lisdexamphetamine (LDX; Vyvanse®).

Condition or disease Intervention/treatment Phase
Planned RRSO Drug: Lisdexamfetamine Drug: Estradiol Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Predictors of Healthy Mood and Memory After Oophorectomy
Actual Study Start Date : July 1, 2013
Actual Primary Completion Date : July 1, 2013
Actual Study Completion Date : July 1, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Active Comparator: lisdexamfetamine
lisdexamfetamine 20 mg/d to 60 mg/d for 12 weeks
Drug: Lisdexamfetamine
Other Name: Vyvanse

Active Comparator: Estradiol
Estradiol 1 mg/d to 3 mg/d for 12 weeks
Drug: Estradiol
Other Name: Estrogen

Placebo Comparator: Placebo Drug: Placebo
Placebo capsules will be filled with lactose powder.




Primary Outcome Measures :
  1. BADDS Score [ Time Frame: 12 weeks ]
    This study uses a double-blind, placebo-controlled, design. The primary subjective outcome variable is the BADDS score measured at the initial screening visit, and one week after oophorectomy and 12 weeks after randomization to E2, LDX or placebo post-oophorectomy. The primary, out-of-scan objective outcome will be performance on the HVLT, while the primary, in-scanner outcomes will be behavioral and brain activation measures during performance of the N-back task.


Secondary Outcome Measures :
  1. Cognitive Functioning [ Time Frame: 12 weeks ]
    The secondary outcome variable studies changes in memory assessed using a battery of cognitive tasks.



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Ages Eligible for Study:   30 Years to 48 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Women ages 30 to 48 will be eligible for this study if they:

  1. Have no previous or present 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;
  2. Planning to undergo an oophorectomy or full hysterectomy;
  3. Are premenopaual (have a baseline follicle stimulating hormone level (FSH) of <20 IU/ml);
  4. Smoke < 10 cigarettes per day
  5. Are right-handed;
  6. Can provide proof of having had a gynecological exam and PAP test done within the previous 3 years at the time of screening;
  7. Can provide proof of having had a mammogram within the previous 12 months at the time of screening;
  8. Are able to give written informed consent;
  9. Must have clear urine toxicology screen upon recruitment;
  10. Are fluent in written and spoken English;
  11. Negative urine pregnancy test.

Exclusion Criteria:

  1. Mini-mental status exam score of less than or equal to 24;
  2. 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;
  3. Lifetime history of drug addiction or abuse, excepting nicotine;
  4. Regular use of other psychotropic medication;
  5. Regular use (more than once a week) of alcohol that is greater than 3 drinks per day;
  6. Presence of a contraindication to treatment with stimulant medication; this would include the presence of hypertension (controlled or uncontrolled), coronary disease, atrial fibrillation, and arrhythmia;
  7. History of seizures;
  8. Presence of a contraindication to treatment with estrogen; this would include the presence of a history of blood clots, and estrogen-receptor positive breast cancer;
  9. Claustrophobia;
  10. History of cardiac disease including known cardiac defect or conduction abnormality;
  11. Abnormal electrocardiogram during screening;
  12. Current pregnancy or planning to become pregnant;
  13. Presence of a metallic implant

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): NCT01986764


Locations
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United States, Pennsylvania
Penn Center for Women's Behavioral Wellness
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: C. Neill Epperson, MD University of Pennsylvania

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Responsible Party: C. Neill Epperson, Associate Professor of Psychiatry, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01986764     History of Changes
Other Study ID Numbers: 817642
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: March 24, 2017
Last Verified: March 2017
Keywords provided by C. Neill Epperson, University of Pennsylvania:
oophorectomy
RRSO
menopause
early menopause
cognition
memory
brain-imaging
Additional relevant MeSH terms:
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Lisdexamfetamine Dimesylate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Central Nervous System Stimulants
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents