At a glance
ClinicalIndex Comparison Record- ✓Clinical diagnosis of unipolar major depression
- ✕Substance abuse
- ✕Psychotic disorder
- ✕History of severe head trauma
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Factors of Treatment Response in Major Depressive Disorder
In Brief
A Phase 4 clinical trial evaluating Venlafaxine (Effexor), Duloxetine (Cymbalta), Escitalopram (Lexapro), Placebo, and 1 other intervention for Depression. Completed, enrolled 88 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.