CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
Lisdexamfetamine +1 moredrug
Likely dose
Lisdexamfetamine 30mgfrom 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/NCT02635035
NCT02635035Phase 2Completed

Efficacy of Lisdexamfetamine in Adults With Attention Deficit Hyperactivity Disorder (ADHD) and Sluggish Cognitive Tempo (SCT)

NYU Langone Health·interventional·Posted Dec 18, 2015·Updated Nov 16, 2021

In Brief

A Phase 2 clinical trial evaluating Lisdexamfetamine and Placebo for Attention Deficit Disorder and Attention Deficit Hyperactivity Disorder. Completed, enrolled 38 participants across 2 sites.

Detailed Summary

The primary purpose of this study is to test the efficacy of Lisdexamfetamine in Adults With Attention Deficit Hyperactivity Disorder (ADHD) and Sluggish Cognitive Tempo (SCT). This is a placebo controlled, cross-over clinical trial of oral Lisdexamfetamine Dimesylate 30-70mg/day in adults with attention-deficit hyper-activity disorder and Sluggish Cognitive Tempo (ACT). Patients will be assigned either LDX/Placebo for 10 weeks with a two week placebo washout period.

Study Details

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

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 18, 2015
Enrollment StartNov 1, 2015
Primary CompletionJan 9, 2019
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 10.5 years ago

Interventions

Lisdexamfetaminedrug

Vyvanse (Lisdexamfetamine Dimesylate) manufactured by Shire, is a Drug Enforcement Administration (DEA) class two,sympathomimetic amine, used for the treatment of attention-deficit hyperactivity disorder. The initial adult dosage is 30mg with allowed adjustments in increments of 10mg or 20mg at weekly intervals. Subjects are initiated on these doses and then they were titrated up by 20mg with a maximum dose of 70mg.

Placebodrug

Placebo looks just like Vyvanse but has no active ingredients, like a sugar pill.