Souza Livia Hartmann, Salum Giovanni Abrahão, Mosqueiro Bruno Paz, Caldieraro Marco Antonio, Guerra Tadeu Assis, Fleck Marcelo P
Mood Disorders Outpatient Program, PROTHUM, Federal University of Rio Grande do Sul, UFRGS/Hospital de Clínicas de Porto Alegre, HCPA, Porto Alegre, Brazil; Post Graduate Program in Medical Sciences: Psychiatry, Federal University of Rio Grande do Sul, UFRGS, Porto Alegre, Brazil.
Post Graduate Program in Medical Sciences: Psychiatry, Federal University of Rio Grande do Sul, UFRGS, Porto Alegre, Brazil; Anxiety Disorders Outpatient Program for Children and Adolescents, PROTAIA, Federal University of Rio Grande do Sul, UFRGS/Hospital de Clínicas de Porto Alegre, HCPA, Porto Alegre, Brazil; National Institute of Developmental Psychiatry for Children and Adolescents (INPD/ CNPq), Brazil.
J Affect Disord. 2016 Mar 15;193:373-80. doi: 10.1016/j.jad.2016.01.004. Epub 2016 Jan 8.
Treatment-resistant depression (TRD) is an extremely prevalent clinical condition. Although Interpersonal Psychotherapy (IPT) is an established treatment for uncomplicated depression, its effectiveness has never before been studied in patients with TRD in real-world settings. We investigate IPT as an adjunct strategy to treatment as usual (TAU) for TRD patients in a pragmatic, randomized, controlled trial.
A total of 40 adult patients with TRD (satisfying the criteria for major depressive disorder despite adequate antidepressant treatment) were recruited from a tertiary care facility for this pragmatic trial and blinded to the evaluator. Patients were randomized to one of two treatment conditions: (1) TAU - pharmacotherapy freely chosen by the clinician (n=23) and (2) TAU+IPT (n=17). Assessments were performed at weeks 8, 12, 19 and 24. Changes in the estimated means of the Hamilton Depression Rating Scale score were the primary outcome measure. Secondary outcomes included patient-rated scales and quality of life scales. We used a linear mixed model to compare changes over time between the two groups.
Both treatments lead to improvements in depressive symptoms from baseline to week 24 with no significant between group differences in either primary: TAU (mean difference: 4.57; CI95%: 0.59-8.55; d=0.73) vs. IPT+TAU (mean difference: 5.86, CI95%: 1.50-10.22; d=0.93) or secondary outcomes.
Our relatively small sample limits our ability to detect differences between treatments.
Both treatments lead to equal improvements in depressive symptoms. We found no evidence to support adding IPT to pharmacotherapy in patients with TRD.
ClinicalTrials.gov-NCT01896349.
难治性抑郁症（TRD）是一种极为常见的临床病症。尽管人际心理治疗（IPT）是治疗单纯性抑郁症的既定疗法，但此前从未在现实环境中的TRD患者身上研究过其有效性。我们在一项实用、随机、对照试验中，将IPT作为常规治疗（TAU）的辅助策略用于TRD患者。
从一家三级医疗保健机构招募了40名成年TRD患者（尽管接受了充分的抗抑郁治疗仍符合重度抑郁症标准）参与这项实用试验，并对评估者进行了盲法处理。患者被随机分为两种治疗组之一：（1）TAU - 临床医生自由选择的药物治疗（n = 23）和（2）TAU + IPT（n = 17）。在第8、12、19和24周进行评估。汉密尔顿抑郁量表评分估计均值的变化是主要结局指标。次要结局包括患者自评量表和生活质量量表。我们使用线性混合模型比较两组随时间的变化。
两种治疗方法均使抑郁症状从基线到第24周有所改善，主要结局（TAU：平均差异：4.57；95%置信区间：0.59 -
8.55；d = 0.73）与IPT + TAU（平均差异：5.86，95%置信区间：1.50 - 10.22；d = 0.93）或次要结局方面两组间均无显著差异。
我们相对较小的样本限制了我们检测治疗方法之间差异的能力。
两种治疗方法在改善抑郁症状方面效果相当。我们没有发现证据支持在TRD患者的药物治疗中添加IPT。
ClinicalTrials.gov - NCT01896349。
