Adjunctive tianeptine treatment for bipolar disorder: A 24-week randomized, placebo-controlled, maintenance trial Academic Article uri icon

  •  
  • Overview
  •  
  • Research
  •  
  • Identity
  •  
  • Additional Document Info
  •  
  • View All
  •  

abstract

  • OBJECTIVE: The purpose of this study was to assess the efficacy and tolerability of tianeptine as an adjunctive maintenance treatment for bipolar depression. METHODS: This is a multicenter double-blind randomized placebo-controlled maintenance trial of adjunctive tianeptine 37.5 mg/day. Participants ( n=161) had a Montgomery-Asberg Depression Rating Scale ⩾12 at entry. After eight weeks of open-label tianeptine treatment, those who responded to tianeptine ( n=69) were randomized to adjunctive tianeptine ( n=36) or placebo ( n=33) in addition to usual treatment. Kaplan-Meier estimates and the Mantel-Cox log-rank test were used to evaluate differences in time to intervention for a mood episode between the tianeptine and placebo groups. We also assessed overall functioning, biological rhythms, quality of life, rates of manic switch and serum brain-derived neurotrophic factor levels. RESULTS: There were no differences between adjunctive tianeptine or placebo regarding time to intervention or depression scores in the 24-week double-blind controlled phase. Patients in the tianeptine group showed better performance in the letter-number sequencing subtest from the Wechsler Adult Intelligence Scale at the endpoint ( p=0.014). Tianeptine was well tolerated and not associated with higher risk for manic switch compared to placebo. CONCLUSION: Tianeptine was not more effective than placebo in the maintenance treatment of bipolar depression. There is preliminary evidence suggesting a pro-cognitive effect of tianeptine in working memory compared to placebo.

authors

  • Kauer-Sant’Anna, Márcia
  • Frey, Benicio
  • Fijtman, Adam
  • Loredo-Souza, Ana C
  • Dargél, Aroldo A
  • Pfaffenseller, Bianca
  • Wollenhaupt-Aguiar, Bianca
  • Gazalle, Fernando K
  • Colpo, Gabriela D
  • Passos, Ives C
  • Bücker, Joana
  • Walz, Júlio C
  • Jansen, Karen
  • Mendes Ceresér, Keila M
  • Bürke Bridi, Kelen P
  • dos Santos Sória, Lisiane
  • Kunz, Maurício
  • Pinho, Michele
  • Kapczinski, Natália S
  • Goi, Pedro D
  • Magalhães, Pedro VS
  • Reckziegel, Ramiro
  • Burque, Renan K
  • de Azevedo Cardoso, Taiane
  • Kapczinski, Flavio

publication date

  • April 2019