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

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ClinicalTrials.gov Identifier: NCT01986777
Recruitment Status : Withdrawn (Funding not obtained)
First Posted : November 18, 2013
Last Update Posted : September 18, 2017
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Cognitive Impairments RRSO Drug: lisdexamfetamine Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: LDX in the Treatment of Executive Function Difficulties in Women After Oophorectomy
Study Start Date : July 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

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 10 weeks.
Drug: lisdexamfetamine
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 8-10 weeks.
Drug: Placebo
The placebo capsules will be filled with lactose.




Primary Outcome Measures :
  1. BADDS Score [ Time Frame: 8-10 weeks ]
    To determine whether treatment with LDX improves self-reported executive function (EF) as measured with the BADDS


Secondary Outcome Measures :
  1. Brain Activation [ Time Frame: 8-10 weeks ]
    To determine the impact of LDX on brain activation in the brain during a working memory task.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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): NCT01986777


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: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01986777     History of Changes
Other Study ID Numbers: 817628
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study has been withdrawn
Keywords provided by University of Pennsylvania:
cognitive complains
RRSO
oophorectomy
memory
cognition
early menopause
Additional relevant MeSH terms:
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Lisdexamfetamine Dimesylate
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
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