Adjunctive tianeptine treatment for bipolar disorder: A 24-week randomized, placebo-controlled, maintenance trial. (April 2019)

• Record Type: Journal Article
• Authors: Kauer-Sant'Anna, Márcia; Frey, Benicio N; 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, Flávio
• Is Part Of: Journal of psychopharmacology. Volume 33:Number 4(2019)
• Page Start: 502
• Page End: 510
• Publication Date: 2019-04
• Subjects: Bipolar disorder -- bipolar depression -- randomized controlled trial -- tianeptine -- antidepressant; Psychopharmacology -- Periodicals; 615.78
• DOI: 10.1177/0269881119826602
• Languages: English
• ISSNs: 0269-8811

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.