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Prevention of Relapse and Recurrence of Bipolar Type I Depression: A Study Protocol for a Multi-site Randomized, Double-blind, Placebo-substitution Trial

Jay D Amsterdam, John Zajecka, Irene Soeller, Michael Topel, Corey Goldstein and Robert J DeRubeis

Background: Bipolar (BP) I disorder affects 1.6% of the US adult population and results in estimated healthcare costs of $40 billion annually. It is characterized by a predominance of major depressive episodes interspersed with manic and hypomanic episodes. Most current practice guidelines are based upon expert consensus and generally recommend using mood stabilizer monotherapy for initial treatment of BP I depression, while avoiding antidepressants and using only mood stabilizer monotherapy for prevention of relapse and recurrence of depression. We hypothesize that long-term mood stabilizer plus antidepressant therapy will result in fewer depressive relapses and recurrences
versus mood stabilizer monotherapy.
Methods/design: 200 patients with BP I depression will receive initial lithium plus fluoxetine therapy for 12 weeks. Responders will be randomized to double-blind maintenance therapy with either: (i) lithium plus fluoxetine, or (ii) lithium monotherapy (following fluoxetine taper and discontinuation) for an additional 50 weeks. The primary outcome is the proportion of subjects in each condition who have a depressive relapse or recurrence during maintenance therapy. Depressive relapse or recurrence is defined as a return of moderate depressive symptoms.
Discussion: We believe that evidence-based medicine will eventually support the use of concurrent antidepressant therapy for prevention of depressive relapse and recurrence in patients with BP I disorder. The paucity of modern controlled clinical trials studying the best method for preventing depressive relapse and recurrence of BP I disorder has led to contradictory practice guidelines and confusion as to the best treatment for BP I disorder. This study seeks to determine whether subjects who respond to initial mood stabilizer plus antidepressant therapy will have a superior longterm
efficacy and fewer depressive relapses and recurrences if they continue therapy with maintenance mood stabilizer plus antidepressant therapy versus mood stabilizer therapy alone.
Trial registration: ClinicalTrials.gov Trials Register - NCT00961961.