NCT01986777

LDX for the Treatment of Cognitive Functioning Issues in Women Post-Oophorectomy

LDX in the Treatment of Executive Function Difficulties in Women After Oophorectomy

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Female
• Age: 30 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a double-blind, placebo-controlled, study testing whether LDX improves cognitive function and EF in 20 postmenopausal women who report onset of cognitive difficulties after oophorectomy (with or without subsequent chemo/adjunctive therapy). Brain imaging is included at critical time points to obtain objective data regarding effects of LDX as well as potential predictors of resilience in the face of oophorectomy.

Detailed description

Participants will be asked to undergo three brain-imaging scans throughout the course of the study. Once they are deemed eligible for participation based on two assessment visits, they will be scheduled for their baseline test day. On this they, they will be asked to under a series of cognitive tests following by a brain-imaging scan. They will then take the first dose of either the LDX or placebo, wait for 3 hours and then undergo another brain-imaging scan to assess acute changes to memory/cognition due to the study drug. They will then come in for three 30-minute check-in visits during weeks 2, 4 and 6 on the study drug. They will be asked to undergo a final scan and series of cognitive tasks during weeks 8-10 on the study drug. They will then be discharged from active study participation. All participants, regardless of randomization, will be offered a consultation with the study MD and optional prescription for 4-weeks of treatment with LDX.

Conditions

• Cognitive Impairments
• RRSO

Interventions

Type	Name	Description
DRUG	lisdexamfetamine
DRUG	Placebo	The placebo capsules will be filled with lactose.

Timeline

• Start date: 2013-07-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-11-18
• Last updated: 2017-09-18

Locations

1 site across 1 country: United States