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

Withdrawn before enrolling · Not applicable · Has a placebo group

Conditions studied: Cognitive Impairments, RRSO

In brief

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.

Key facts

Study ID

NCT01986777

Run by

University of Pennsylvania

People needed

0

Starts

2013-07-01

Expected to finish

2013-12-01

Last updated by the study team

2017-09-18

Who can join

Age: 30 and older, up to 60. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Penn Center for Women's Behavioral Wellness — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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