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一项双盲、安慰剂对照的随机临床试验,研究胞磷胆碱治疗双相和单相抑郁以及甲基苯丙胺依赖的效果。

A randomized, double-blind, placebo-controlled trial of citicoline for bipolar and unipolar depression and methamphetamine dependence.

机构信息

Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX 75390-8849, USA.

出版信息

J Affect Disord. 2012 Dec 20;143(1-3):257-60. doi: 10.1016/j.jad.2012.05.006. Epub 2012 Sep 11.

DOI:10.1016/j.jad.2012.05.006
PMID:22974472
Abstract

BACKGROUND

Methamphetamine use disorders are common and severe problems. Persons with mood disorders, particularly bipolar disorder, have high rates of substance use disorders. We previously reported promising findings on drug use, memory and study retention in patients with a history of mania and cocaine dependence given the nutritional supplement citicoline. In the current proof-of-concept study, we examined citicoline in bipolar or unipolar depression and methamphetamine dependence.

METHODS

Sixty adults with bipolar depression or major depressive disorder and methamphetamine dependence were randomized to citicoline (2000mg/day) or placebo for 12 weeks. Mood was assessed using Inventory of Depressive Symptomatology-Clinician Version (IDS-C), and cognition with the Hopkins Auditory Verbal Learning Test (HVLT). Drug use was assessed by urine drug screens.

RESULTS

An ANCOVA of the intent-to-treat sample showed that those receiving citicoline (n=28) had a statistically significantly greater improvement in IDS-C scores than those receiving placebo (n=20). Survival in the study was significantly longer and completion rates significantly greater with citicoline than placebo. No significant differences were observed in memory or methamphetamine use. Citicoline was well tolerated.

LIMITATIONS

Sample heterogeneity and small sample size were limitations.

CONCLUSIONS

To our knowledge this is the first placebo-controlled trial in a dual diagnosis sample with methamphetamine use disorders. Findings suggest that citicoline may have antidepressant properties in this population. Greater treatment retention with citicoline is also noteworthy in a patient population with substance dependence. Larger trials targeting depressive symptoms and treatment retention seem warranted.

摘要

背景

甲基苯丙胺使用障碍是常见且严重的问题。患有心境障碍的人,特别是双相情感障碍患者,物质使用障碍的发生率较高。我们之前报告过在有躁狂症和可卡因依赖病史的患者中使用营养补充剂胞磷胆碱的药物使用、记忆和研究保留方面的有希望的结果。在当前的概念验证研究中,我们研究了胞磷胆碱在双相或单相抑郁和甲基苯丙胺依赖中的作用。

方法

60 名患有双相抑郁或重性抑郁障碍和甲基苯丙胺依赖的成年人被随机分配接受胞磷胆碱(2000mg/天)或安慰剂治疗 12 周。使用抑郁症状清单-临床版(IDS-C)评估情绪,使用霍普金斯听觉言语学习测试(HVLT)评估认知。通过尿液药物筛查评估药物使用情况。

结果

意向治疗样本的协方差分析显示,接受胞磷胆碱(n=28)治疗的患者 IDS-C 评分的改善明显优于接受安慰剂(n=20)治疗的患者。接受胞磷胆碱治疗的患者在研究中的生存时间明显更长,完成率明显更高。在记忆或甲基苯丙胺使用方面没有观察到显著差异。胞磷胆碱耐受性良好。

局限性

样本异质性和样本量小是限制因素。

结论

据我们所知,这是首例针对甲基苯丙胺使用障碍的双诊断样本的安慰剂对照试验。研究结果表明,胞磷胆碱可能对该人群具有抗抑郁作用。胞磷胆碱治疗保留率更高,这在有物质依赖的患者群体中也值得注意。针对抑郁症状和治疗保留率的更大规模试验似乎是合理的。

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