Massachusetts General Hospital and Harvard Medical School, Boston, MA 02114, USA.
Mol Psychiatry. 2013 Mar;18(3):332-9. doi: 10.1038/mp.2011.166. Epub 2011 Dec 13.
Despite decades of intensive research, the development of a diagnostic test for major depressive disorder (MDD) had proven to be a formidable and elusive task, with all individual marker-based approaches yielding insufficient sensitivity and specificity for clinical use. In the present work, we examined the diagnostic performance of a multi-assay, serum-based test in two independent samples of patients with MDD. Serum levels of nine biomarkers (alpha1 antitrypsin, apolipoprotein CIII, brain-derived neurotrophic factor, cortisol, epidermal growth factor, myeloperoxidase, prolactin, resistin and soluble tumor necrosis factor alpha receptor type II) in peripheral blood were measured in two samples of MDD patients, and one of the non-depressed control subjects. Biomarkers measured were agreed upon a priori, and were selected on the basis of previous exploratory analyses in separate patient/control samples. Individual assay values were combined mathematically to yield an MDDScore. A 'positive' test, (consistent with the presence of MDD) was defined as an MDDScore of 50 or greater. For the Pilot Study, 36 MDD patients were recruited along with 43 non-depressed subjects. In this sample, the test demonstrated a sensitivity and specificity of 91.7% and 81.3%, respectively, in differentiating between the two groups. The Replication Study involved 34 MDD subjects, and yielded nearly identical sensitivity and specificity (91.1% and 81%, respectively). The results of the present study suggest that this test can differentiate MDD subjects from non-depressed controls with adequate sensitivity and specificity. Further research is needed to confirm the performance of the test across various age and ethnic groups, and in different clinical settings.
尽管经过几十年的深入研究，开发一种用于重度抑郁症（MDD）的诊断测试已被证明是一项艰巨而难以捉摸的任务，因为所有基于单个标志物的方法在临床应用中都没有足够的敏感性和特异性。在本研究中，我们在两个独立的 MDD 患者样本中检查了基于多分析物的血清测试的诊断性能。在两个 MDD 患者样本和一个非抑郁对照样本中，测量了外周血中 9 种生物标志物（α1 抗胰蛋白酶、载脂蛋白 CIII、脑源性神经营养因子、皮质醇、表皮生长因子、髓过氧化物酶、催乳素、抵抗素和可溶性肿瘤坏死因子-α受体 II）的血清水平。测量的生物标志物是事先达成一致的，并基于在单独的患者/对照样本中的先前探索性分析进行选择。通过数学方法将单个分析物值组合起来以获得 MDD 评分。“阳性”测试（与 MDD 的存在一致）定义为 MDD 评分大于等于 50。在试点研究中，招募了 36 名 MDD 患者和 43 名非抑郁对照者。在该样本中，该测试在区分两组时的敏感性和特异性分别为 91.7%和 81.3%。复制研究涉及 34 名 MDD 患者，得出的敏感性和特异性几乎相同（分别为 91.1%和 81%）。本研究的结果表明，该测试可以将 MDD 患者与非抑郁对照者以足够的敏感性和特异性区分开来。需要进一步的研究来确认该测试在不同年龄、种族群体和不同临床环境中的性能。
