Evaluation of Depression Symptoms and Brain Activity Associated With Response to Treatment of Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will use measurements of depression symptoms and brain activity to determine what
      factors may influence an individual's response to treatment for depression.
    

Detailed description: 
      We are using depression symptom measurements and measurements of brain electrical activity
      (EEG) to determine what factors may influence whether a patient is likely to show a response
      to antidepressant medication, placebo, or only clinical visits (without the use of pills)
      during a treatment trial for depression.
    

Intervention name(s): Venlafaxine (Effexor), Duloxetine (Cymbalta), Escitalopram (Lexapro); Placebo; Interpersonal Clinical Interaction (ICI)
Intervention type(s): Drug; Other; Behavioral
Intervention description(s): Subjects assigned to the placebo (PBO) or medication (MED) condition will enter double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They will undergo the same schedule, structure, and intensity of visits as in the ICI condition, but also will be randomized to receive treatment with a pill. Subjects randomized to medication will be started on one tablet each morning of either venlafaxine XR 75 mg., duloxetine 30 mg., or escitalopram 10 mg. Dosages will be increased in a double-blinded manner by increasing the number of pills administered by one pill every three to five days until the final dose is achieved (225 mg., 90 mg., and 30 mg. respectively for venlafaxine XR, duloxetine, and escitalopram). In order to maintain blinding during dosage increase, the number of tablets of placebo will be increased every three to five days as well.; Subjects assigned to the placebo (PBO) or medication (MED) condition will enter double-blind treatment with either venlafaxine XR, duloxetine, escitalopram, or placebo after lead-in. They will undergo the same schedule, structure, and intensity of visits as in the ICI condition, but also will be randomized to receive treatment with a pill. Subjects randomized to medication will be started on one tablet each morning of either venlafaxine XR 75 mg., duloxetine 30 mg., or escitalopram 10 mg. Dosages will be increased in a double-blinded manner by increasing the number of pills administered by one pill every three to five days until the final dose is achieved (225 mg., 90 mg., and 30 mg. respectively for venlafaxine XR, duloxetine, and escitalopram). In order to maintain blinding during dosage increase, the number of tablets of placebo will be increased every three to five days as well.; Interaction with and assessment by clinical research personnel on a fixed schedule, with the pharmacotherapeutic alliance assessed both by research personnel and subjects.
Intervention MeSH terms: Duloxetine Hydrochloride; Venlafaxine Hydrochloride; Escitalopram
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Major depressive disorder; MDD; Antidepressant