drugset / Trial / NCT01665950

Simvastatin Augmentation of Lithium Treatment in Bipolar Depression

NCT01665950

Phase 2 Terminated 4 enrolled Massachusetts General Hospital
RandomizedParallel-groupDouble-blindTreatment

Summary

Primary Aim: To estimate the antidepressant efficacy of simvastatin versus placebo as an adjunct to lithium, valproate, and/or other atypical antipsychotic therapy among individuals with bipolar I disorder in a nonpsychotic major depressive episode. Hypothesis: Simvastatin will be superior to placebo in improvement of depressive symptoms assessed by the Montgomery-Asberg Depression Rating Scale (MADRS).

Timeline

Start
2012-08
Primary completion
2014-10
Completion
2014-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Simvastatin Small molecule 20 mg

Indications