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A randomized controlled trial of antidepressant continuation for major depression following traumatic brain injury.

机译:颅脑外伤后重度抑郁的抗抑郁药继续使用抗抑郁药的随机对照试验。

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OBJECTIVE: This study examines whether continuation therapy with citalopram can prevent a relapse following remission of major depression due to traumatic brain injury. METHOD: After 65 subjects with DSM-IV-diagnosed major depression following traumatic brain injury were treated with open-label citalopram (20 mg to 50 mg/d), 25 subjects (38.5%) met criteria for remission. Of those, 21 (84.0%) were randomly assigned to either same-dose citalopram or placebo and followed monthly over 40 weeks. Remission was defined as a Hamilton Depression Rating Scale (HDRS) score of /= 16. Data were collected from February 16, 2005, to May 5, 2008. RESULTS: Ten subjects were randomly assigned to citalopram and 11 to placebo. There were 3 dropouts, including 1 for adverse drug effects (diarrhea). Relapse occurred in 11 subjects (52.4%), with a mean +/- SD time to relapse of 23.52 +/- 16.6 weeks. The groups did not differ in relapse rates (drug: 50.0% [5/10] vs placebo: 54.5% [6/11], Fisher exact test, P = .835) or time to relapse (log rank test chi(2) = 0.148, P = .700). CONCLUSIONS: The present study suggests important limitations of continuation pharmacotherapy in the prevention of relapse of major depression following traumatic brain injury. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00162916.
机译:目的:本研究研究了西酞普兰持续治疗是否可以预防因颅脑外伤而导致的严重抑郁症缓解后的复发。方法:对65例DSM-IV诊断为脑外伤后重度抑郁的受试者进行了开放标签西酞普兰(20 mg至50 mg / d)的治疗,然后有25例受试者(38.5%)达到了缓解标准。在这些患者中,有21名(84.0%)被随机分配至相同剂量的西酞普兰或安慰剂,并每月随访40周。缓解定义为汉密尔顿抑郁量表(HDRS)得分 / =16。数据收集自2005年2月16日至2008年5月5日。 :将10名受试者随机分配给西酞普兰,将11名受试者分配给安慰剂。有3例辍学,包括1例药物不良反应(腹泻)。 11名受试者(52.4%)发生了复发,平均+/- SD复发时间为23.52 +/- 16.6周。两组的复发率(药物:50.0%[5/10]与安慰剂:54.5%[6/11],Fisher精确检验,P = .835)或复发时间(对数秩检验chi(2))没有差异。 = 0.148,P = .700)。结论:本研究提示继续药物治疗在预防脑外伤后重度抑郁症复发方面的重要局限性。试验注册:clinicaltrials.gov标识符:NCT00162916。

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