CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 35 enrolled
Drug / intervention
Lisdexamfetamine Dimesylate (Vyvanse) +1 moredrug
Likely dose
Lisdexamfetamine Dimesylate (Vyvanse) 20mgfrom 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/NCT01148979
NCT01148979Phase 4Completed

Double-Blind, Placebo-Controlled, Randomized Trial of Adjunctive Lisdexamfetamine Dimesylate in Residual Symptoms of Major Depressive Disorder Partially Responsive to Selective Serotonin or Norepinephrine Reuptake Inhibitor Monotherapy

Mclean Hospital·interventional·Posted Jun 23, 2010·Updated May 23, 2017

In Brief

A Phase 4 clinical trial evaluating Lisdexamfetamine Dimesylate (Vyvanse) and Placebo for Major Depressive Disorder. Completed, enrolled 35 participants across 1 site.

Detailed Summary

This study aims to test the effect of a newly-approved stimulant medication, lisdexamfetamine dimesylate (Vyvanse), on specific residual symptoms of depression found in some patients who are undergoing treatment with, but have only partially responded to, a selective-serotonin reuptake inhibitor (SSRI) or selective-norepinephrine reuptake inhibitor (SNRI) antidepressant. Specifically, the investigators hypothesize that symptoms potentially related to deficient dopaminergic activity, such as lassitude, apathy, reduced positive affect and impaired executive function, in particular, will improve. This protocol is designed to test the hypothesis that this cluster of co-occurring residual symptoms sometimes found in treated depression will respond as a group to adjunctive psychostimulant therapy. The investigators propose to demonstrate this cluster of residual depressive symptoms and to measure the effect of stimulant therapy on it. The investigators hope to better understand the specific symptoms in this clinical population that are likely to improve with stimulant therapy.

Study Details

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

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 23, 2010
Enrollment StartSep 1, 2010
Primary CompletionSep 1, 2014
Study CompletionOct 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 16.0 years ago

Interventions

Lisdexamfetamine Dimesylate (Vyvanse)drug

Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.

Placebodrug

Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules.