Major Depressive Disorder Clinical Trial
Official title:
Biochemical Brain Changes Correlated With The Antidepressant Effect Of Thyroid Hormones
We propose to investigate structural and biochemical brain abnormalities in depressed
subjects, and the relationship between the presence of such abnormalities and treatment
outcome. We will recruit N=20 subjects with major depression disorder and N=20 matched
normal controls. The depressed subjects would have previously not responded to an adequate
trial with a selective serotonin reuptake inhibitor (SSRI). These depressed subjects will be
treated for 4 weeks with the same SSRI antidepressant and with adjuvant triiodothyronine
(T3). Structural magnetic resonance images (MRI) and then Phosphorus-31 magnetic resonance
spectroscopic imaging (31P-MRSI) data will be obtained two times for each patient (at the
beginning and at the end of the study) and one time for the normal controls. We will measure
for each depressed subject the number of white matter hyperintensities (WMH); we will also
measure the degree of change from baseline in several compounds characteristic for the
cellular high-energy phosphate metabolism: the phosphocreatine/inorganic phosphate ratio and
the beta-nucleoside triphosphate. We will compare the severity of WMH and the high-energy
phosphate metabolism in two groups of depressed subjects (those responding and those not
responding to thyroid hormone augmentation) and the normal controls.
We hypothesize that:
1. All depressed subjects, when compared with normal controls, will present lower baseline
levels of compounds characteristic for the high-energy phosphate metabolism.
2. Depressed subjects responding to T3 augmentation, when compared with subjects not
responding to T3 augmentation, will present a larger increase of the high-energy
phosphate metabolism.
n/a
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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