ADJUNCTIVE ACUPUNCTURE TO TREAT BIPOLAR DEPRESSION

精神障碍的补充和替代疗法越来越受欢迎，尽管缺乏关于其安全性、耐受性或有效性的严格科学数据。这项拟议中的研究增加了一小部分评估针灸治疗情绪障碍的文献，但文献越来越多。主要目的是评估单独使用针灸和精神药理学治疗的可行性和有效性。这项研究将复制NIMH资助的先前研究中设计的针灸诊断和治疗方法。将评估受试者的期望在针灸治疗中的作用。根据临床结果，患者将被随机分为针灸+稳定药物组(Acup N=15)或非特异性针灸+稳定药物组(NS Acup N=15)。与针灸医生的临床接触将等同于两组(12个疗程，8周)。患者、评分员和精神病学家将对小组分配视而不见。纳入标准现在要求进入研究的是中度(与轻度)抑郁，以最大限度地减少研究的混乱，如自发改善。加强了维持学习保留的安全措施和程序。针灸患者每周将与RA和精神科医生会面，以完成评分(IDS-C、CGI-BP、YMRS、GAF)，并评估副作用和症状严重程度。我们将纳入一个对照组(TAU)，这些患者符合入选标准，但拒绝接受针灸干预。这些受试者将继续接受药物治疗，回顾图表审计将使我们能够确定在该样本中仅药物治疗预期的变化程度。虽然临床试验已经解决了针灸治疗单相抑郁的疗效，但存在着一个独特的机会，可以将针灸治疗双相情感障碍抑郁症状的研究带来类似的严谨性。这一建议的一个优点是它复制了其他研究人员在MDD针灸研究中开发和使用的方法。如果针灸在治疗双相情感障碍方面显示出有效性，将建议进行进一步的研究，以评估其在维持和预防方面的作用。

Complementary and alternative therapies for psychiatric disorders are increasingly popular despite the lack of rigorous scientific data addressing their safety, tolerability, or efficacy. The proposed study adds to a small but growing body of literature to evaluate acupuncture in the treatment of mood disorders. The primary aims are to evaluate the feasibility and efficacy of acupuncture treatment in conjunction with psychopharmacology alone. The study will replicate methods of acupuncture diagnosis and treatment designed in a previous NIMH- funded study. The role of subjects' expectancies for acupuncture treatment will be evaluated. Patients will be randomized to either acupuncture plus stable medications (ACUP N=15) on clinical outcome or non-specific acupuncture plus stable medications (NS ACUP N=15). Clinical contact with an acupuncturist will be equivalent for both groups (12 sessions, 8 weeks). Patients, raters, and psychiatrists will be blind to group assignment. The criteria for inclusion now require moderate (vs. mild) depression for study entry to minimize study confounds such as spontaneous improvement. Safety measures and procedures to maintain study retention have been strengthened. Acupuncture patients will meet weekly with an RA and psychiatrist to complete ratings (IDS-C, CGI-BP, YMRS, GAF) and to assess side effects and symptom severity. We will include a comparison group (TAU) of patients who met entry criteria but refused the acupuncture intervention. Those subjects will continue to receive pharmacological treatment, and retrospective chart audit will allow us to determine the degree of change expected from medication treatment alone in this sample. While clinical trials have addressed the efficacy of acupuncture treatment for unipolar depression, a unique opportunity exists to bring similar rigor to the study of acupuncture for depressive symptoms in bipolar disorder. A strength of this proposal is its replication of methodology developed and used by other researchers in a study of acupuncture in MDD. Should acupuncture demonstrate efficacy in the treatment of bipolar disorder, further studies will be proposed to evaluate its utility for maintenance and prevention.