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Lisdexamfetamine Dimesylate in Residual Symptoms and Cognitive Impairment in Major Depressive Disorder.

Major Depressive Disorder Clinical Trial

Official title:
Double-Blind, Placebo-Controlled, Randomized Trial of Adjunctive, Flexibly-Dosed Lisdexamfetamine Dimesylate in Residual Symptoms and Cognitive Impairment In Major Depressive Disorder (MDD) Partially Responsive to Selective Serotonin Reuptake Inhibitor (SSRI) or Selective Norepinephrine Reuptake Inhibitor (SNRI) Monotherapy

Clinical Trial Summary

This study aims to test the effect of a newly-approved stimulant medication, lisdexamfetamine (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 psychostimulant therapy. The investigators propose to measure this cluster of symptoms in a population of residually depressed subjects demonstrating them, and then to measure the effect of stimulant therapy on this cluster, and each constituent symptom, as well as to measure its effect on subjects' overall functional impairment, and to document treatment emergent adverse effects. The investigators hope to better understand the specific symptoms in this clinical population that are likely to improve with stimulant therapy. The investigators also hope to be able to characterize the side effect burden of stimulant therapy in this clinical population.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01148979
Study type Interventional
Source Mclean Hospital
Contact
Status Completed
Phase Phase 4
Start date September 2010
Completion date October 2014
View Details
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