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

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: Márcia Kauer-Sant'Anna, Benicio N Frey, Adam Fijtman, Ana C Loredo-Souza, Aroldo A Dargél, Bianca Pfaffenseller, Bianca Wollenhaupt-Aguiar, Fernando K Gazalle, Gabriela D Colpo, Ives C Passos, Joana Bücker, Júlio C Walz, Karen Jansen, Mendes Ceresér, Kelen P Bürke Bridi, Lisiane Dos Santos Sória, Maurício Kunz, Michele Pinho, Natália S Kapczinski, Pedro D Goi, Pedro Vs Magalhães, Ramiro Reckziegel, Renan K Burque, Taiane de Azevedo Cardoso, Flávio Kapczinski
• Journal: Journal of psychopharmacology (Oxford, England) (J Psychopharmacol) Vol. 33 Issue 4 Pg. 502-510 (04 2019) ISSN: 1461-7285 [Electronic] United States
• PMID: 30835152 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antidepressive Agents, Tricyclic
• Brain-Derived Neurotrophic Factor
• Thiazepines
• tianeptine

Topics

• Adult
• Antidepressive Agents, Tricyclic (adverse effects, therapeutic use)
• Bipolar Disorder (blood, drug therapy)
• Brain-Derived Neurotrophic Factor (blood)
• Double-Blind Method
• Drug Therapy, Combination (statistics & numerical data)
• Female
• Humans
• Male
• Memory, Short-Term (drug effects)
• Thiazepines (adverse effects, therapeutic use)
• Treatment Outcome
• Wechsler Scales (statistics & numerical data)
• Young Adult