Continuation and long-term maintenance treatment with Hypericum extract WS® 5570 after successful acute treatment of mild to moderate depression Ð rationale and study design

S. KASPER,¹ A. DIENEL,² M. KIESER^3
1Department of General Psychiatry, Medical University of Vienna, Austria
²Clinical Trials Group Hypericum, Dr Willmar Schwabe Pharmaceuticals, Karlsruhe, Germany
³Biometry Department, Dr Willmar Schwabe Pharmaceuticals, Karlsruhe, Germany

Abstract
Unipolar major depression is often a chronic disease that may require lifelong prophylaxis. Recovery from an acute episode is followed by 4–6 months of relapse prevention. After that, long-term maintenance treatment is administered to avoid recurrence. We present the rationale and design of an ongoing double-blind, randomized, placebo-controlled trial investigating the efficacy of Hypericum extract WS® 5570 in relapse prevention in recurrent unipolar depression. An estimated sample of 425 adults with recurrent, mild to moderate major depression (ICD-10 and DSM-IV criteria), >3 previous episodes (last 5 years) and a total score >20 points on the 17-item Hamilton Rating Scale for Depression (HAMD) will be included. After a one-week wash out patients receive 3 x 300 mg/day WS® 5570 single-blind for 6 weeks. Responders are randomized to 26 weeks of double-blind continuation treatment with 3 x 300 mg/day WS® 5570 or placebo. Patients completing continuation treatment without relapse enter 52 weeks of doubleblind maintenance treatment, where those treated with WS® 5570 are re-randomized to 3 x 300 mg/day WS® 5570 or placebo. The primary outcome measure is the time to relapse during continuation treatment (HAMD >16, clinical diagnosis of depression, or premature treatment termination for inefficacy). Hypericum extract, with its favourable tolerability profile, could be an interesting option for long-term prophylaxis. The trial was designed according to current consensus and guidance. Notably, it includes long-term prophylactic treatment with the same drug and the same therapeutic dose applied during acute treatment, uses well-defined outcome measures and provides a clear distinction between relapse and recurrence.

Key words: Hypericum extract, chronic unipolar depression, prophylactic treatment, relapse, recurrence

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