Bipolar Disorder Clinical Trial
Official title:
Adjunctive Isradipine for the Treatment of Bipolar Depression
This study investigates the medication isradipine, which is currently approved by the FDA to treat high blood pressure, in the treatment of depression in bipolar disorder. Isradipine or placebo (contains no active medication) will be used as an "add-on" to lithium, valproate, and/or atypical antipsychotics for individuals currently experiencing a major depressive episode. Our hypothesis is that isradipine will be superior to placebo in improving depressive symptoms.
Primary Aim: To estimate the antidepressant efficacy of isradipine versus placebo as an
adjunct to lithium, valproate, and/or other atypical antipsychotics among individuals with
bipolar I disorder in a nonpsychotic major depressive episode.
Hypothesis: Isradipine will be superior to placebo in improvement of depressive symptoms
assessed by the Montgomery-Asberg Depression Rating Scale (MADRS).
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