Treating Insulin Resistance With Metformin as a Strategy to Improve Clinical Outcomes in Treatment-Resistant Bipolar Depression (the TRIO-BD Study): A Randomized, Quadruple-Masked, Placebo-Controlled Clinical Trial

As hypothesized, successful reversal of IR by metformin resulted in a statistically significant and clinically meaningful reduction in depression rating scale scores in patients suffering from TRBD. Fifty percent of insulin-resistant TRBD patients treated with metformin converted to insulin-sensitive , and improvements in depression ratings that were first noted at 6 weeks were sustained up to 26 weeks.

No serious adverse events occurred over the course of this trial. Adverse events that did occur were primarily gastrointestinal symptoms commonly associated with metformin and were equally prevalent in the placebo group.found that BD patients with IR have equally poor outcomes as those with more advanced metabolic dysregulation .

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