CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 69 enrolled
Drug / intervention
Lisdexamfetamine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03187353
NCT03187353Phase 4Completed

Multi-Modal Imaging of Psychostimulant Effects on Executive Function Post-RRSO

University of Pennsylvania·interventional·Posted Jun 14, 2017·Updated Nov 18, 2023

In Brief

A Phase 4 clinical trial evaluating Lisdexamfetamine and Placebo oral capsule for Cognitive Impairment and RRSO. Completed, enrolled 69 participants across 1 site.

Detailed Summary

This is a double-blind, placebo-controlled, crossover study testing whether Vyvanse (lisdexamfetamine; LDX) improves executive functioning (EF) in 100 postmenopausal women who report onset of EF difficulties after oophorectomy. This study involves magnetic resonance imaging (MRI) to see how LDX affects brain chemistry while undergoing two 6-week trials of the study drug and placebo capsules. UPDATE: We have recently updated this protocol (09/2020) to offer a remote version of the study that can be completed entirely from the participant's home. This alternate version of the study eliminates travel, the MRI, and blood draws.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedJun 14, 2017
Enrollment StartSep 22, 2017
Primary CompletionApr 30, 2022
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 9.0 years ago

Interventions

Lisdexamfetaminedrug

Stimulant medications are used to reduce interruptive behavior, fidgeting, and other hyperactive symptoms, as well as help a person finish tasks and improve his or her relationships for adults who have ADHD. Please note that the FDA has not approved the use of Vyvanse® for the treatment of memory and concentration difficulties related to medically induced menopause.

Placebo oral capsuledrug

The placebo capsule will be filled with microcellulose.