Lisdexamfetamine Dimesylate in Residual Symptoms and Cognitive Impairment in Major Depressive Disorder.
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      This protocol is designed to test the hypothesis that a cluster of co-occurring residual
      symptoms sometimes found in treated depression will respond as a group to psychostimulant
      therapy. This cluster includes apathy, reduced drive, fatigue, impaired executive function
      and other cognitive measures, and low positive affect. We 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 goal is to gather data about the response of these
      residual symptoms to stimulant therapy. Since each subject will be exposed to active
      treatment and matched placebo, a benefit to individual participants will be to learn if their
      specific symptom burden is ameliorated by stimulant therapy, and what adverse effects may
      emerge for them. We hope to develop an understanding of the specific symptoms in this
      clinical population that are likely to improve with stimulant therapy. We also hope to be
      able to characterize the side effect burden of stimulant therapy in this clinical population.
    

Intervention name(s): Lisdexamfetamine Dimesylate (Vyvanse); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.; Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules.
Other intervention name(s): Vyvanse; Sugar pill
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a double-blind, placebo-controlled, crossover study in which each subject will act as their own control after being randomly assigned to placebo or Lisdexamfetamine Dimesylate (Vyvanse) for the first 4 weeks of study treatment, then receiving the other for the second 4 weeks of treatment. The two 4-week treatment periods are separated by a washout of 2 weeks.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Cognitive Impairment; Partial Response; Residual Symptoms