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J Clin Psychiatry. 2016 May;77(5):654-60. doi: 10.4088/JCP.15m10181.
To evaluate remission and recovery, safety, and tolerability for up to 12 months of open-label adjunctive L-methylfolate calcium 15 mg.
Subjects in this analysis were adult outpatients (18-65 years) enrolled from 2 acute, double-blind, placebo-controlled trials comparing adjunctive L-methylfolate and placebo for DSM-IV major depressive disorder (MDD) with an inadequate response to monotherapy selective serotonin reuptake inhibitor (SSRI). Subjects who completed the acute trial were offered to enroll in a 12-month, open-label treatment phase with L-methylfolate and continued SSRI treatment, with scheduled visits for efficacy, safety, and tolerability every 12 weeks. Subjects were enrolled between September 2006 and February 2010. Efficacy outcomes included predefined criteria for response, remission, recovery, relapse, and recurrence. Subjects treated with adjunctive L-methylfolate 15 mg were included in the efficacy analysis.
Of 68 subjects who met criteria for the 12-month open-label phase, 38% (n = 26) achieved full recovery, and none experienced a recurrence of MDD. For subjects entering the open-label phase in remission (n = 11), 91% (n = 10) achieved full recovery with L-methylfolate 15 mg, and none experienced a relapse or recurrence. Among 57 subjects who entered the open-label phase as nonremitted, 61% (n = 35) achieved remission. Of subjects who entered the open-label phase with a response without remission (n = 4), 50% (n = 2) had full recovery, and of subjects entering the open-label phase with no response (n = 53), 26% (n = 14) met recovery criteria.
Adjunctive L-methylfolate 15 mg/d may be an early option in patients who fail to adequately respond to antidepressant monotherapy, with preliminary evidence demonstrating sustained remission and sustained recovery.
ClinicalTrials.gov identifier: NCT00321152.
评估为期 12 个月的开放性辅助左亚叶酸钙 15mg 的缓解和恢复情况、安全性和耐受性。
本分析中的受试者为参加 2 项急性、双盲、安慰剂对照试验的成年门诊患者（18-65 岁），这些试验比较了左亚叶酸钙辅助治疗和安慰剂对单相治疗选择性 5-羟色胺再摄取抑制剂（SSRI）应答不足的 DSM-IV 重性抑郁障碍（MDD）。完成急性试验的受试者可选择参加为期 12 个月的开放性辅助左亚叶酸钙治疗阶段，并继续 SSRI 治疗，每 12 周进行一次疗效、安全性和耐受性的预定访视。受试者于 2006 年 9 月至 2010 年 2 月入组。疗效结局包括应答、缓解、恢复、复发和再发的预先设定标准。纳入了接受辅助左亚叶酸钙 15mg 治疗的受试者进行疗效分析。
在符合 12 个月开放性试验条件的 68 名受试者中，38%（n=26）达到完全恢复，且无人出现 MDD 复发。对于进入开放性辅助治疗阶段缓解的受试者（n=11），91%（n=10）用左亚叶酸钙 15mg 达到完全恢复，且无人出现复发或再发。在进入开放性辅助治疗阶段未缓解的 57 名受试者中，61%（n=35）达到缓解。在进入开放性辅助治疗阶段应答但未缓解的受试者（n=4）中，50%（n=2）达到完全恢复，在进入开放性辅助治疗阶段无应答的受试者（n=53）中，26%（n=14）达到恢复标准。
左亚叶酸钙 15mg/d 可能是对抗抑郁药单药治疗应答不足的患者的早期选择，初步证据表明持续缓解和持续恢复。
ClinicalTrials.gov 标识符：NCT00321152。
