Major Depressive Disorder Clinical Trial
Official title:
Augmentation of the Antidepressant Action of Sertraline With Triiodothyronine (T3)and Reboxetine: Clinical Efficacy, Adverse Effects and Predictors of Response.
In this project we aim to further refine indications for the use of the thyroid hormone - T3 for patients suffering from depression. We aim to identify a sub-group of patients who are more likely to respond to T3 and establish the time in the treatment course when T3 should be added. The results of this project could have significant, direct clinical implications.
The lifetime risk for major depressive disorder (MDD) is 15% in the general population.
Current treatment approaches emphasize the achievement of remission. Remission implies
virtual absence of depressive symptoms and is associated with better function and a better
overall prognosis than response, which is usually defined as a 50% reduction in symptom
severity. Sixty percent or more of patients treated optimally with antidepressants remain
un-remitted and will need additional treatment. A potentially effective but under-exploited
strategy to augment antidepressant effects is concurrent administration of the thyroid
hormone, triiodothyronine (T3). We previously demonstrated the clinical efficacy and safety
of T3 administered concurrently with the SSRI, sertraline, in the context of a randomized,
double-blind placebo-controlled trial. Although all the patients were euthyroid, remission
rates were significantly higher in the sertraline plus T3 group and were associated with
significantly lower baseline T3 values and a significant decrease in serum thyroid
stimulating hormone (TSH) values during the course of treatment.
The study aims to:
- Delineate a sub-population of depressed patients treated with sertraline, who are more
likely to respond to T3 augmentation on the basis of thyroid function and genetic
variation in thyroid pathway genes.
- Investigate the appropriate timing for the addition of T3.
- Assess the efficacy of reboxetine, a specific noradrenaline reuptake inhibitor, as a
further supplement to the treatment of un-remitted patients. The results of this study
could have a significant, direct clinical impact on the pharmacological treatment of
MDD.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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