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



Status:Recruiting
Conditions:Cognitive Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:30 - 60
Updated:4/2/2016
Start Date:July 2013
End Date:December 2017
Contact:Claudia J Iannelli, MS
Email:sclaud@mail.med.upenn.edu
Phone:214-417-8839

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LDX in the Treatment of Executive Function Difficulties in Women After Oophorectomy

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.

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.

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.
We found this trial at
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Philadelphia, Pennsylvania 19104
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