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

• Status: Withdrawn
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pennsylvania
• Treatments: Lisdexamfetamine Dimesylate

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.