LDX and Functional Magnetic Resonance Imaging (fMRI in Menopausal Women

Menopause Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01977625
• Other study ID #: 814735
• Status: Completed
• Phase: Phase 4
• Start date: December 2011
• Est. completion date: April 2014

Study information

• Verified date: July 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Activity
• Cognition
• Menopause

Intervention

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

Locations

Country	Name	City	State
United States	University of Pennsylvania, Penn Center for Womens Behavioral Wellness	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Shire

Country where clinical trial is conducted

United States, 

References & Publications (3)

Epperson CN, Pittman B, Czarkowski KA, Bradley J, Quinlan DM, Brown TE. Impact of atomoxetine on subjective attention and memory difficulties in perimenopausal and postmenopausal women. Menopause. 2011 May;18(5):542-8. doi: 10.1097/gme.0b013e3181fcafd6. — View Citation

Epperson CN, Shanmugan S, Kim DR, Mathews S, Czarkowski KA, Bradley J, Appleby DH, Iannelli C, Sammel MD, Brown TE. New onset executive function difficulties at menopause: a possible role for lisdexamfetamine. Psychopharmacology (Berl). 2015 Aug;232(16):3 — View Citation

Shanmugan S, Loughead J, Nanga RP, Elliott M, Hariharan H, Appleby D, Kim D, Ruparel K, Reddy R, Brown TE, Epperson CN. Lisdexamfetamine Effects on Executive Activation and Neurochemistry in Menopausal Women with Executive Function Difficulties. Neuropsyc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Blood Oxygen Level Dependent (BOLD) Signal	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.	10 weeks
Secondary	Change in BADDS Total Score	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.	10 weeks