1 Laboratory of Molecular Psychiatry, Hospital de Clínicas de Porto Alegre (HCPA), Federal University of Rio Grande do Sul, Porto Alegre, Brazil.
2 Department of Psychiatry, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.
J Psychopharmacol. 2019 Apr;33(4):502-510. doi: 10.1177/0269881119826602. Epub 2019 Mar 5.
The purpose of this study was to assess the efficacy and tolerability of tianeptine as an adjunctive maintenance treatment for bipolar depression.
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.
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.
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.
本研究旨在评估噻奈普汀作为双相抑郁症辅助维持治疗的疗效和耐受性。
这是一项噻奈普汀 37.5mg/天辅助维持的多中心双盲随机安慰剂对照试验。参与者（n=161）在入组时的 Montgomery-Asberg 抑郁评定量表（MADRS）评分 ⩾12。在 8 周的噻奈普汀开放标签治疗后，对噻奈普汀有反应的患者（n=69）被随机分为噻奈普汀辅助治疗组（n=36）或安慰剂组（n=33），同时接受常规治疗。采用 Kaplan-Meier 估计和 Mantel-Cox 对数秩检验评估噻奈普汀组和安慰剂组之间情绪发作干预时间的差异。我们还评估了整体功能、生物节律、生活质量、躁狂转换率和血清脑源性神经营养因子水平。
在 24 周的双盲对照阶段，噻奈普汀辅助治疗或安慰剂组在干预时间或抑郁评分方面没有差异。在终点时，噻奈普汀组在韦氏成人智力量表的字母数字排序子测试中表现更好（p=0.014）。噻奈普汀耐受性良好，与安慰剂相比，躁狂转换的风险没有增加。
噻奈普汀在双相抑郁症的维持治疗中并不优于安慰剂。有初步证据表明，与安慰剂相比，噻奈普汀在工作记忆方面具有认知促进作用。
