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LDX and Functional Magnetic Resonance Imaging (fMRI in Menopausal Women

This study has been completed.
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01977625
First received: October 30, 2013
Last updated: July 31, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention Phase
Menopause Brain Activity Cognition Drug: Lisdexamfetamine Other: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Utilizing fMRI to Determine the Effects of Vyvanse® on Memory, Attention, and Brain Activity in Menopausal Women

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Enrollment: 18
Study Start Date: December 2011
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lisdexamfetamine
Lisdexamfetamine or Vyvanse
Drug: Lisdexamfetamine
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 Name: Vyvanse®
Placebo Comparator: Sugar Pill
Placebo pill, capsules
Other: Placebo
To assess the effects of a placebo pill on brain activation patterns during tasks of sustained attention and working memory in menopausal women.
Other Name: Sugar pill

  Eligibility

Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. 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;
  2. Are within 5 years of last menstrual period (LMP);
  3. Have a follicular stimulating hormone level (FSH) of 20 IU/ml;
  4. Are able to give written informed consent;
  5. Must have clear urine toxicology screen upon recruitment;
  6. Are fluent in written and spoken English;
  7. Are right-handed;
  8. Negative urine pregnancy test if still menstruating.

Exclusion Criteria:

  1. Mini-mental status exam score of less than or equal to 24;
  2. 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;
  3. Lifetime history of drug addiction or abuse, except nicotine;
  4. Regular use of other psychotropic medication;
  5. Regular use (more than once a week) of alcohol that is less than 3 drinks/day;
  6. 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;
  7. History of seizures;
  8. History of cardiac disease including known cardiac defect or conduction abnormality;
  9. Abnormal electrocardiogram during screening;
  10. Use of estrogen therapy within previous 2 months;
  11. Current pregnancy or planning to become pregnant;
  12. Metallic implant;
  13. Claustrophobia.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01977625

Locations
United States, Pennsylvania
University of Pennsylvania, Penn Center for Womens Behavioral Wellness
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Shire
Investigators
Principal Investigator: Cynthia Neill Epperson, M.D. University of Pennsylvania
  More Information

Publications:
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01977625     History of Changes
Other Study ID Numbers: 814735
Study First Received: October 30, 2013
Results First Received: September 8, 2016
Last Updated: July 31, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Pennsylvania:
Menopause
fMRI
Vyvanse

Additional relevant MeSH terms:
Lisdexamfetamine Dimesylate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on September 21, 2017