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首页> 外文期刊>The journal of clinical psychiatry >A double-blind, placebo-controlled study of the efficacy and safety of desvenlafaxine succinate in the treatment of major depressive disorder.
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A double-blind, placebo-controlled study of the efficacy and safety of desvenlafaxine succinate in the treatment of major depressive disorder.

机译：琥珀酸去甲文拉法辛治疗主要抑郁症的功效和安全性的双盲，安慰剂对照研究。

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OBJECTIVE: This study evaluated the efficacy and safety of desvenlafaxine succinate extended-release in major depressive disorder (MDD). METHOD: Adult outpatients with DSM-IV-defined MDD were randomly assigned to desvenlafaxine 100 mg/day (N = 114), 200 mg/day (N = 116), or 400 mg/day (N = 113) or placebo (N = 118) for 8 weeks. Efficacy variables included change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D(17), the primary efficacy measure), Clinical Global Impressions-Improvement scale (CGI-I), Montgomery-Asberg Depression Rating Scale, Clinical Global Impressions-Severity of Illness scale (CGI-S), rates of response (> or = 50% decrease from baseline HAM-D(17) score) and remission (HAM-D(17) score < or =7), and Visual Analog Scale-Pain Intensity overall score. The study was conducted from November 2003 to November 2004. RESULTS: At the final on-therapy evaluation, the mean HAM-D(17) scores for desvenlafaxine 100 mg/day (12.75) and 400 mg/day (12.50) were significantly lowerthan for placebo (15.31; p = .0038 and p .0023, respectively); for desvenlafaxine 200 mg/day, the mean score was 13.31 (p = .0764). CGI-I and Montgomery-Asberg Depression Rating Scale results were significant for all groups; CGI-S results were significant with 100 mg/day and 400 mg/day. Response rates were significantly greater for desven-lafaxine 100 mg/day (51%) and 400 mg/day (48%) versus placebo (35%; p = .017 and p = .046, respectively); the response rate for desvenlafaxine 200 mg/day was 45% (p = .142). Remission rates were significantly greater for desvenlafaxine 400 mg/day (32%) versus placebo (19%; p = .035); remission rates were 30% for desvenlafaxine 100 mg/day (p .093) and 28% for desvenlafaxine 200 mg/day (p Scale-Pain Intensity results were significant for desvenlafaxine 100 mg/day versus placebo (p = .002), but not for the higher doses. The most commonly reported adverse events were nausea, insomnia, somnolence, dry mouth, dizziness, sweating, nervousness, anorexia, constipation, asthenia, and abnormal ejaculation/orgasm. CONCLUSIONS: Desvenlafaxine is effective and well tolerated in the short-term treatment of MDD.
机译：目的：本研究评估了琥珀酸去甲文拉法辛缓释剂在重度抑郁症（MDD）中的疗效和安全性。方法：将患有DSM-IV定义的MDD的成人门诊患者随机分配给去甲文拉法辛100 mg /天（N = 114），200 mg /天（N = 116）或400 mg /天（N = 113）或安慰剂（N = 118），持续8周。疗效变量包括17个项的汉密尔顿抑郁量表（HAM-D（17），主要功效量度），临床总体印象改善量表（CGI-I），蒙哥马利-阿斯伯格抑郁量表，临床值与基线相比的变化。总体印象-疾病严重程度量表（CGI-S），缓解率（相对于基线HAM-D（17）得分降低>或= 50％）和缓解（HAM-D（17）得分<或= 7），以及视觉模拟量表疼痛强度总体得分。该研究于2003年11月至2004年11月进行。结果：在最终的治疗评估中，去甲文拉法辛100 mg / day（12.75）和400 mg / day（12.50）的HAM-D（17）平均得分明显低于对于安慰剂（分别为15.31; p = .0038和p .0023）;去甲文拉法辛200 mg /天的平均评分为13.31（p = .0764）。 CGI-I和蒙哥马利-阿斯伯格抑郁量表的结果对所有组均显着。 CGI-S结果在100 mg /天和400 mg /天时很显着。与安慰剂组相比，去甲-拉法辛100 mg /天（51％）和400 mg / day（48％）的应答率明显更高（分别为35％; p = .017和p = .046）;去甲文拉法辛200 mg /天的缓解率为45％（p = .142）。 Devenlafaxine 400 mg / day（32％）的缓解率明显高于安慰剂（19％; p = .035）;地文拉法辛100 mg /天的缓解率是30％（p .093），地斯文拉法辛200 mg / day的缓解率是28％（p地塞痛强度结果与安慰剂相比100 mg / day是显着的（p = .002），但是结论：去甲文拉法辛是有效的并且耐受性好MDD的短期治疗。

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