title: Adjunctive agomelatine therapy in the treatment of acute bipolar II depression: a preliminary open label study.
abstract: OBJECTIVE
  The circadian rhythm hypothesis of bipolar disorder (BD) suggests a role for melatonin in regulating mood, thus extending the interest toward the melatonergic antidepressant agomelatine as well as type I (acute) or II cases of bipolar depression.
  
  
  METHODS
  Twenty-eight depressed BD-II patients received open label agomelatine (25 mg/bedtime) for 6 consecutive weeks as an adjunct to treatment with lithium or valproate, followed by an optional treatment extension of 30 weeks. Measures included the Hamilton depression scale, Pittsburgh Sleep Quality Index, the Clinical Global Impression Scale-Bipolar Version, Young Mania Rating Scale, and body mass index.
  
  
  RESULTS
  Intent to treat analysis results demonstrated that 18 of the 28 subjects (64%) showed medication response after 6 weeks (primary study endpoint), while 24 of the 28 subjects (86%) responded by 36 weeks. When examining primary mood stabilizer treatment, 12 of the 17 (70.6%) valproate and six of the 11 (54.5%) lithium patients responded by the first endpoint. At 36 weeks, 14 valproate treated (82.4%) and 10 lithium treated (90.9%) subjects responded. At 36 weeks, there was a slight yet statistically significant (P = 0.001) reduction in body mass index and Pittsburgh Sleep Quality Index scores compared to respective baseline values, regardless of mood stabilizer/outcome. Treatment related drop-out cases included four patients (14.28%) at week 6 two valproate-treated subjects with pseudo-vertigo and drug-induced hypomania, respectively, and two lithium-treated subjects with insomnia and mania, respectively. Week 36 drop outs were two hypomanic cases, one per group.
  
  
  CONCLUSIONS
  Agomelatine 25 mg/day was an effective and well-tolerated adjunct to valproate/lithium for acute depression in BD-II, suggesting the need for confirmation by future double blind, controlled clinical trials.
authors: Department of Formative Sciences, University of Catania, Catania, Italy.
authors: Michele
authors: M
authors: Fornaro
authors: Michael J
authors: MJ
authors: McCarthy
authors: Domenico
authors: D
authors: De Berardis
authors: Concetta
authors: C
authors: De Pasquale
authors: Massimo
authors: M
authors: Tabaton
authors: Matteo
authors: M
authors: Martino
authors: Salvatore
authors: S
authors: Colicchio
authors: Carlo Ignazio
authors: CI
authors: Cattaneo
authors: Emanuela
authors: E
authors: D'Angelo
authors: Pantaleo
authors: P
authors: Fornaro
keywords: acute bipolar depression; adjunctive treatment; agomelatine; bipolar disorder type-II