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Completed

NCT Number: NCT01977625

LDX and Functional Magnetic Resonance Imaging (fMRI in Menopausal Women

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.

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Key information

Age range

45 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

University of Pennsylvania, Penn Center for Womens Behavioral Wellness

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Lisdexamfetamine

Drug

The overall objective of this study is to assess the effects of LDX on brain activation patterns during tasks of sustained attention and working memory in menopausal women.

Other names: Vyvanse®

Placebo

Other

To assess the effects of a placebo pill on brain activation patterns during tasks of sustained attention and working memory in menopausal women.

Other names: Sugar pill

Primary outcomes

  1. Percent Change in Blood Oxygen Level Dependent (BOLD) Signal

    Time frame: 10 weeks

    Blood-oxygen-level dependent contrast imaging, or BOLD-contrast imaging, is a method used in functional magnetic resonance imaging (fMRI) to observe different areas of the brain or other organs, which are found to be active at any given time. BOLD signals were compared from baseline, first intervention and second intervention.

Secondary outcomes

  1. Change in BADDS Total Score

    Time frame: 10 weeks

    The total BADDS ranged from 0-120 with higher scores meaning greater problems with memory, attention and focus. Difference in BADDS score from Baseline to End of Treatment for each study Arm was calculated.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Shire

Registry information

Official study title

Utilizing fMRI to Determine the Effects of Vyvanse® on Memory, Attention, and Brain Activity in Menopausal Women

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 6, 2013
Registry last updated
Jul 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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