University of Texas Southwestern Medical School, Dallas, Texas 75235, United States.
J Affect Disord. 2010 Nov;126(3):420-9. doi: 10.1016/j.jad.2010.04.011. Epub 2010 May 26.
Psychosocial outcomes from the Prevention of Recurrent Episodes of Depression with Venlafaxine ER for Two Years (PREVENT) study were evaluated.
Adult outpatients with recurrent major depressive disorder (MDD) and response or remission following 6-month continuation treatment with venlafaxine extended release (ER) were randomized to receive venlafaxine ER or placebo for 1 year. Patients without recurrence on venlafaxine ER during year 1 were randomized to venlafaxine ER or placebo for year 2. Psychosocial functioning was assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q), Life Enjoyment Scale-Short Version (LES-S), Social Adjustment Scale-Self-Report (SAS-SR) total and individual factors, Short Form Health Survey (SF-36) (vitality, social functioning, and role function-emotional items), and Longitudinal Interval Follow-up Evaluation (LIFE).
At year 1 end, better overall psychosocial functioning was seen among patients randomly assigned to venlafaxine ER (n=129) vs placebo (n=129), with significant differences at end point on SF-36 role function-emotional, Q-LES-Q, and SAS-SR total, and work, house work, social/leisure, and extended-family factor scores (p≤0.05). At year 2 end, significant differences favored venlafaxine ER (n=43) vs placebo (n=40) on SF-36 vitality and role function-emotional, Q-LES-Q, LES-S, LIFE, and SAS-SR total, social/leisure, and extended-family factor scores (p≤0.05).
Patients with chronic MDD or treatment resistance were excluded and long-term specialist care was a financial incentive for treatment compliance. Discontinuation-related adverse events may have compromised the integrity of the treatment blind.
For patients with recurrent MDD, 2 years' maintenance therapy with venlafaxine ER may improve psychosocial functioning vs placebo.
评估了文拉法辛 ER 预防复发性抑郁发作 2 年（PREVENT）研究的心理社会结局。
接受文拉法辛 ER 6 个月维持治疗后有反应或缓解的复发性重性抑郁障碍（MDD）成年门诊患者，被随机分配接受文拉法辛 ER 或安慰剂治疗 1 年。在第 1 年接受文拉法辛 ER 治疗且未复发的患者，被随机分配接受文拉法辛 ER 或安慰剂治疗第 2 年。使用生活质量享受和满意度问卷-短表（Q-LES-Q）、生活享受量表-短表（LES-S）、社会调整量表-自我报告（SAS-SR）总分和个体因子、健康调查简表（SF-36）（活力、社会功能和角色功能-情感项目）和纵向间隔随访评估（LIFE）评估心理社会功能。
在第 1 年末，随机分配到文拉法辛 ER（n=129）的患者的整体心理社会功能更好，与终点时 SF-36 角色功能-情感、Q-LES-Q 和 SAS-SR 总分以及工作、家务、社会/休闲和大家庭因子评分有显著差异（p≤0.05）。在第 2 年末，与安慰剂（n=40）相比，文拉法辛 ER（n=43）在 SF-36 活力和角色功能-情感、Q-LES-Q、LES-S、LIFE 和 SAS-SR 总分、社会/休闲和大家庭因子评分上有显著差异（p≤0.05）。
排除了慢性 MDD 或治疗抵抗的患者，并且长期专科护理是治疗依从性的经济激励。与停药相关的不良事件可能会影响治疗的盲法完整性。
对于复发性 MDD 患者，文拉法辛 ER 维持治疗 2 年可能比安慰剂改善心理社会功能。
