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J Psychopharmacol ; 33(4): 502-510, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30835152

RESUMO

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.


Assuntos
Transtorno Bipolar/tratamento farmacológico , Tiazepinas/uso terapêutico , Adulto , Antidepressivos Tricíclicos/efeitos adversos , Antidepressivos Tricíclicos/uso terapêutico , Transtorno Bipolar/sangue , Fator Neurotrófico Derivado do Encéfalo/sangue , Método Duplo-Cego , Quimioterapia Combinada/estatística & dados numéricos , Feminino , Humanos , Masculino , Memória de Curto Prazo/efeitos dos fármacos , Tiazepinas/efeitos adversos , Resultado do Tratamento , Escalas de Wechsler/estatística & dados numéricos , Adulto Jovem
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