CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 35 enrolled
Drug / intervention
Lisdexamfetamine +1 moredrug
Likely dose
Lisdexamfetamine 60 mgfrom 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/NCT01324024
NCT01324024Phase 4Completed

Attention & Memory Impairments in Menopausal Women: A Possible Role for Vyvanse?

University of Pennsylvania·interventional·Posted Mar 28, 2011·Updated Jun 28, 2017

In Brief

A Phase 4 clinical trial evaluating Lisdexamfetamine and Placebo for Symptomatic Menopause and Cognitive Impairments. Completed, enrolled 35 participants across 1 site.

Detailed Summary

The purpose of this study is to determine whether a medication called Vyvanse® (lisdexamfetamine; LDX) has an impact on cognitive functioning, specifically measures of sustained attention, verbal encoding and recall and working memory, in menopausal aged women. LDX is a medication used to treat attention deficit hyperactivity disorder (ADHD). The cognitive difficulties that menopausal women report experiencing are typical of adults who are diagnosed with ADHD. The investigators will assess whether or not LDX is effective in alleviating those cognitive disruptions when compared to a placebo.

Study Details

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

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 28, 2011
Enrollment StartMay 1, 2011
Primary CompletionApr 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 15.3 years ago

Interventions

Lisdexamfetaminedrug

In a counterbalanced fashion, participants would receive titrated doses of LDX 20 to 60 mg/d for 4 weeks followed by a 2-week washout and then crossed over to the placebo tablets for another 4 weeks. All women will start with LDX 20 mg/d and then be titrated to 40 mg/d after 1 week and 60 mg/d after 2 weeks (as tolerated).

Placebodrug

In a counterbalanced fashion, participants would receive placebo tablets for 4 weeks followed by a 2 week washout, then will receive titrated doses of LDX 20 to 60 mg/d for 4 weeks.