LDX and Functional Magnetic Resonance Imaging (fMRI in Menopausal Women

Completed · Phase 4 · Has a placebo group

Conditions studied: Menopause, Brain Activity, Cognition

In brief

This study seeks to assess the effects of lisdexamfetamine (trademark name: Vyvanse; LDX) on executive function and prefrontal cortex activation in menopausal women ages 45-57, who report subjective cognitive difficulties. This protocol will recruit women from Dr. Epperson's ongoing study, Protocol #812470, to examine the impact of LDX on brain activation during performance of cognitive tasks specifically probing prefrontal cortex function.

Key facts

Study ID

NCT01977625

Run by

University of Pennsylvania

People needed

18

Starts

2011-12-01

Expected to finish

2014-04-01

Last updated by the study team

2018-07-27

Who can join

Age: 45 and older, up to 60. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Have no previous or present history of a DSM-IV psychiatric or substance dependence disorder within the previous year, according to the Structured Clinical Interview for Diagnosis- DSM-IV (SCID)-Non-Patient Version;
• Are within 5 years of last menstrual period (LMP);
• Have a follicular stimulating hormone level (FSH) of 20 IU/ml;
• Are able to give written informed consent;
• Must have clear urine toxicology screen upon recruitment;
• Are fluent in written and spoken English;
• Are right-handed;
• Negative urine pregnancy test if still menstruating.

You may not qualify if…

• Mini-mental status exam score of less than or equal to 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;
• Regular use of other psychotropic medication;
• Regular use (more than once a week) of alcohol that is less than 3 drinks/day;
• Presence of a contraindication to treatment with stimulant medication unless the condition is controlled with medication; this would include the presence of 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;
• Use of estrogen therapy within previous 2 months;
• Current pregnancy or planning to become pregnant;
• Metallic implant;
• Claustrophobia.

Where it is running

• University of Pennsylvania, Penn Center for Womens Behavioral Wellness — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.