LDX and Functional Magnetic Resonance Imaging (fMRI in Menopausal Women

NCT01977625 | Completed Phase 4 Results

• 1 other identifier: 814735
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Menopause; Brain Activity; Cognition

Keywords

Menopause; fMRI; Vyvanse

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in BADDS Total Score

  10 weeks

Study Arms (2)

Lisdexamfetamine

ACTIVE COMPARATOR

Lisdexamfetamine or Vyvanse

Drug: Lisdexamfetamine

Sugar Pill

PLACEBO COMPARATOR

Placebo pill, capsules

Other: Placebo

Interventions

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.

Also known as: Vyvanse®

Lisdexamfetamine

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.

Also known as: Sugar pill

Sugar Pill

Eligibility Criteria

• Age: 45 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• University of Pennsylvania: lead
• Shire: collaborator

Study Sites (1)

University of Pennsylvania, Penn Center for Womens Behavioral Wellness

Philadelphia, Pennsylvania, 19104, United States

Location

Related 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.

  PMID: 21293309 BACKGROUND

• 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):3091-100. doi: 10.1007/s00213-015-3953-7. Epub 2015 Jun 11.

  PMID: 26063677 RESULT

• 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. Neuropsychopharmacology. 2017 Jan;42(2):437-445. doi: 10.1038/npp.2016.162. Epub 2016 Aug 23.

  PMID: 27550732 RESULT

MeSH Terms

Interventions

Lisdexamfetamine Dimesylate; Sugars

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Carbohydrates

Results Point of Contact

• Title: C. Neill Epperson, M.D
• Organization: University of Pennsylvania

cepp@mail.med.upenn.edu

215-573-8871

Study Officials

• Cynthia Neill Epperson, M.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2013
• First Posted: November 6, 2013
• Study Start: December 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: July 27, 2018
• Results First Posted: July 11, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)