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Phase 4 N=18 Randomized Double-blind Treatment

LDX and Functional Magnetic Resonance Imaging (fMRI in Menopausal Women

Menopause · Brain Activity · Cognition

Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Percent Change in Blood Oxygen Level Dependent (BOLD) Signal — 0.41; -0.11 percent change

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Lisdexamfetamine (Drug); Placebo (Other)
Age
Adult · 45+ yrs
Sex
Female
Sponsor
University of Pennsylvania
Primary completion
Apr 2014

Outcome Measures

OutcomeResultp-value
PRIMARY
Percent Change in Blood Oxygen Level Dependent (BOLD) Signal
0.41; -0.11
SECONDARY
Change in BADDS Total Score
-23.36; -8.57

Summary

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.

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01977625). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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