VA Palo Alto Health Care System, 3801 Miranda Ave (151T), Palo Alto, CA 94304
J Clin Psychiatry. 2014 Jan;75(1):77-84. doi: 10.4088/JCP.12m08297.
Bipolar disorder often co-occurs with anxiety disorders. Evidence suggests that second-generation antipsychotics (SGAs) may be useful in treating both conditions. This study examined the efficacy of ziprasidone in the treatment of these disorders.
This 3-site, randomized, double-blind, placebo-controlled, parallel group, 8-week trial of ziprasidone monotherapy examined 49 subjects with bipolar disorder and lifetime panic disorder (with or without agoraphobia) or generalized anxiety disorder (GAD) experiencing moderately severe anxiety symptoms at entrance into the study. Both bipolar disorder and anxiety diagnoses were based on DSM-IV-TR criteria. Patients were screened and randomized from June 25, 2010, through August 23, 2011. Primary outcome measures were the Clinical Global Impressions-21 Anxiety Scale (CGI-21 Anxiety) and the Sheehan Disability Scale (SDS), with secondary measures monitoring anxiety and mood symptoms.
Last-observation-carried-forward analyses demonstrated that patients in the ziprasidone group did not improve significantly more than those in the placebo group on the CGI-21 Anxiety (F1 = 0.34; P = .564) or SDS (F1 = 0.26; P = .611). Secondary analysis using hierarchical linear modeling found similar results (CGI-21 Anxiety: F1 = 1.82; P = .178; and SDS: F1 = 0.70; P = .408). Regardless of group, time in the study was associated with significant decrease in anxiety (F1 = 11.08; P = .001) and total disability (F1 = 26.16; P < .001). Patients in the ziprasidone group showed a greater increase in abnormal involuntary movement, and 81.8% (n = 9) of the subjects who withdrew from the study due to adverse events, serious adverse events, or side effects were in the ziprasidone group.
Results suggest that ziprasidone monotherapy was not associated with a clinically significant improvement in anxiety symptoms or improved function for patients with bipolar disorder, lifetime panic disorder or GAD, and concurrent moderately severe anxiety symptoms, and it was associated with a more negative side-effect profile relative to placebo.
ClinicalTrials.gov identifier: NCT01172652.
双相情感障碍常与焦虑障碍共病。有证据表明，第二代抗精神病药物（SGAs）可能对这两种疾病都有治疗作用。本研究考察了齐拉西酮治疗这些疾病的疗效。
这是一项为期 8 周的、在 3 个地点进行的、随机、双盲、安慰剂对照、平行分组的齐拉西酮单药治疗试验，共纳入 49 例双相情感障碍且有终生惊恐障碍（伴或不伴广场恐怖症）或广泛性焦虑障碍（GAD）的患者，这些患者在进入研究时伴有中度严重的焦虑症状。双相情感障碍和焦虑症的诊断均基于 DSM-IV-TR 标准。患者于 2010 年 6 月 25 日至 2011 年 8 月 23 日期间进行筛查和随机分组。主要疗效指标为临床总体印象-21 焦虑量表（CGI-21 焦虑）和 Sheehan 残疾量表（SDS），次要指标监测焦虑和情绪症状。
末次观测结转分析显示，与安慰剂组相比，齐拉西酮组患者在 CGI-21 焦虑（F1 = 0.34；P =.564）或 SDS（F1 = 0.26；P =.611）上的改善程度无显著差异。采用层次线性模型的二次分析得出了类似的结果（CGI-21 焦虑：F1 = 1.82；P =.178；SDS：F1 = 0.70；P =.408）。无论分组如何，研究时间与焦虑（F1 = 11.08；P =.001）和总残疾（F1 = 26.16；P <.001）的显著下降均相关。齐拉西酮组患者出现更多的异常不自主运动，因不良事件、严重不良事件或副作用而退出研究的 81.8%（n = 9）的受试者均在齐拉西酮组。
结果表明，齐拉西酮单药治疗与双相情感障碍、终生惊恐障碍或 GAD 伴中度严重焦虑症状患者的焦虑症状改善或功能改善无关，与安慰剂相比，齐拉西酮治疗组的不良反应谱更为负面。
ClinicalTrials.gov 标识符：NCT01172652。
