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In each study following a 4 week single-blind placebo baseline period, patients were randomized, under double blind conditions, to divalproex sodium or placebo for a 12 week treatment phase, comprised of a 4 week dose titration period followed by an 8 week maintenance period.

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The PEARLS intervention consisted of problem-solving treatment, social and physical activation, and potential recommendations to patients' physicians regarding antidepressant medications.

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The high risk of neural tube defects and other major malformations in babies exposed during the first trimester to valproate sodium and the related products, valproic acid and divalproex sodium, is the focus of an FDA notice.

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