Major Depressive Disorder Clinical Trial
Official title:
Dopaminergic Effects of Adjunctive Aripiprazole on the Brain in Treatment-Resistant Depression: A Raclopride/F-DOPA Positron Emission Tomography and Functional MRI Study
Aripiprazole has been approved by the FDA for augmenting ineffective/partially effective oral antidepressant therapy in patients suffering from major depression. The mechanism by which this augmentation is achieved is not known. This study has been designed to test the hypothesis that the primary mechanism of action of aripiprazole (ARP) antidepressant augmentation is through the dopaminergic pathway. Two positron emission tomography (PET) scan procedures and a functional magnetic resonance imaging (fMRI) scan will be used to test this hypothesis.
This study is designed to help understand the mechanism of action of ARP in major depressive
disorder (MDD) augmentation. Subjects will undergo exposure to an existing antidepressant
(Lexapro 10-20mg) for 10 weeks; subjects failing to completely respond to the monotherapy
antidepressant treatment will receive augmentation with ARP for six weeks. Two placebo phases
are included in which the subjects will receive one placebo along with the Lexapro for the
first 6 weeks and a second placebo along with Lexapro for the next two weeks. A baseline
brain imaging series (MRI and 2 PET/CT scans) will be obtained at week 10, prior to starting
the aripiprazole, on subjects not responding to Lexapro. A second series of images will be
obtained at the end of the six weeks of ARP augmentation. The neuroimaging will consist of
fMRI, a raclopride PET scan, and a fluoro-dopa PET scan.
Ten normal control subjects will not receive any treatment. They will be age and gender
matched to study subjects and undergo one set of scans (fMRI,raclopride and FOPA PET scans)
to use as comparison group for quality control on a non-depressed population and not for data
analysis.
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