Am J Psychiatry. 2014 Jan;171(1):44-53. doi: 10.1176/appi.ajp.2013.12101353.
Most patients remain symptomatic after an initial intervention with approved treatments for generalized social anxiety disorder. This randomized controlled trial provides systematic, prospectively derived data on the relative benefits of "next-step" pharmacotherapies to improve outcomes for individuals with generalized social anxiety disorder who remain symptomatic after initial treatment.
This three site, 12-week, double-blind randomized controlled trial compared the relative benefits of three strategies for patients remaining symptomatic (Liebowitz Social Anxiety Scale [LSAS] score >50) after a 10-week trial of sertraline alone: the addition of up to 3.0 mg/day of clonazepam (sertraline plus clonazepam), a switch to up to 225 mg/day of venlafaxine, or prolonged sertraline treatment with placebo (sertraline plus placebo).
A total of 397 participants received at least one dose of sertraline; 181 nonresponders (LSAS score >50) at week 10 were randomly assigned to sertraline plus clonazepam, switch to venlafaxine, or sertraline plus placebo. Overall, 21% of patients achieved remission (LSAS score ≤30) at the endpoint, and 27% of patients assigned to sertraline plus clonazepam achieved remission compared with patients assigned to sertraline plus placebo (17%) or venlafaxine (19%), but the differences did not reach significance. Sertraline plus clonazepam was associated with a significantly greater drop in LSAS severity (p=0.020) and disability (p=0.0028) compared with sertraline plus placebo; no significant differences were observed on these parameters between venlafaxine and either sertraline plus placebo or sertraline plus clonazepam. In supplemental analysis, the overall response rate (LSAS score ≤50) was 46%, including a significantly greater proportion of patients in the sertraline plus clonazepam group (56%) compared with the sertraline plus placebo group responding (36%; p=0.027); differences did not reach significance between venlafaxine and sertraline plus placebo or sertraline plus clonazepam.
The findings suggest that the clonazepam augmentation strategy provides relative benefits for sertraline nonresponders in social anxiety disorder.
大多数患者在接受通用社交焦虑障碍的批准治疗进行初始干预后仍有症状。这项随机对照试验提供了系统的、前瞻性的“下一步”药物治疗数据，以改善初始治疗后仍有症状的通用社交焦虑障碍患者的治疗效果。
这项三地点、为期 12 周、双盲随机对照试验比较了三种策略对接受单独舍曲林治疗 10 周后仍有症状（Liebowitz 社交焦虑量表[LSAS]评分>50）的患者的相对益处：加用最高 3.0 毫克/天的氯硝西泮（舍曲林加氯硝西泮）、换用最高 225 毫克/天的文拉法辛，或延长舍曲林治疗同时使用安慰剂（舍曲林加安慰剂）。
共有 397 名参与者至少接受了一剂舍曲林；10 周时 181 名无应答者（LSAS 评分>50）被随机分配至舍曲林加氯硝西泮、换用文拉法辛或舍曲林加安慰剂。总体而言，21%的患者在终点时达到缓解（LSAS 评分≤30），与舍曲林加安慰剂相比，舍曲林加氯硝西泮组（27%）和文拉法辛组（19%）的患者达到缓解的比例更高，但差异无统计学意义。舍曲林加氯硝西泮与舍曲林加安慰剂相比，LSAS 严重程度（p=0.020）和残疾（p=0.0028）显著降低，而文拉法辛与舍曲林加安慰剂或舍曲林加氯硝西泮相比，这些参数无显著差异。在补充分析中，LSAS 评分≤50 的总体反应率为 46%，包括舍曲林加氯硝西泮组（56%）显著高于舍曲林加安慰剂组（36%）（p=0.027）；文拉法辛与舍曲林加安慰剂或舍曲林加氯硝西泮组之间无显著差异。
这些发现表明，氯硝西泮增效策略对社交焦虑障碍中舍曲林无应答者有相对益处。
