Docherty John P, Sack David A, Roffman Mark, Finch Manley, Komorowski James R
Comprehensive NeuroScience, Inc., White Plains, NY, USA.
J Psychiatr Pract. 2005 Sep;11(5):302-14. doi: 10.1097/00131746-200509000-00004.
: In a small pilot trial, patients with atypical depression demonstrated significant positive therapeutic response to chromium picolinate. This finding is of interest because of the demonstrated link between depression, decreased insulin sensitivity, and subsequent diabetes and chromium picolinate's insulin enhancing effect.
: In this double-blind, multicenter, 8-week replication study, 113 adult outpatients with atypical depression were randomized 2:1 to receive 600 mug/day of elemental chromium, as provided by chromium picolinate (CrPic), or placebo. Primary efficacy measures were the 29-item Hamilton Depression Rating Scale (HAM-D-29) and the Clinical Global Impressions Improvement Scale (CGI-I).
: Of the 113 randomized patients, 110 (70 CrPic, 40 placebo) constituted the intent-to-treat (ITT) population (i.e., received at least one dose of study medication and completed at least one efficacy evaluation) and 75 (50 CrPic, 25 placebo) were evaluable (i.e., took at least 80% of study drug with no significant protocol deviations). In the evaluable population, mean age was 46 years, 69% were female, 81% were Caucasian, and mean body mass index (BMI) was 29.7. There was no significant difference between the CrPic and placebo groups in both the ITT and evaluable populations on the primary efficacy measures, with both groups showing significant improvement from baseline on total HAM-D-29 scores during the course of treatment (p < 0.0001). However, in the evaluable population, the CrPic group showed significant improvements from baseline compared with the placebo group on 4 HAM-D-29 items: appetite increase, increased eating, carbohydrate craving, and diurnal variation of feelings. A supplemental analysis of data from the subset of 41 patients in the ITT population with high carbohydrate craving (26 CrPic, 15 placebo; mean BMI = 31.1) showed that the CrPic patients had significantly greater response on total HAM-D-29 scores than the placebo group (65% vs. 33%; p < 0.05) as well as significantly greater improvements on the following HAM-D-29 items: appetite increase, increased eating, carbohydrate craving, and genital symptoms (e.g., level of libido). Chromium treatment was well-tolerated.
: The study did not include a placebo run-in period, did not require minimum duration or severity of depression, and enrolled patients with major depression, dysthymia, or depression NOS.
: In a population of adults with atypical depression, most of whom were overweight or obese, CrPic produced improvement on the following HAM-D-29 items: appetite increase, increased eating, carbohydrate craving, and diurnal variation of feelings. In a subpopulation of patients with high carbohydrate craving, overall HAM-D-29 scores improved significantly in patients treated with CrPic compared with placebo. The results of this study suggest that the main effect of chromium was on carbohydrate craving and appetite regulation in depressed patients and that 600 mug of elemental chromium may be beneficial for patients with atypical depression who also have severe carbohydrate craving. Further studies are needed to evaluate chromium in depressed patients specifically selected for symptoms of increased appetite and carbohydrate craving as well as to determine whether a higher dose of chromium would have an effect on mood.
在一项小型试点试验中，非典型抑郁症患者对吡啶甲酸铬表现出显著的积极治疗反应。这一发现备受关注，因为抑郁症、胰岛素敏感性降低以及后续糖尿病之间已证实存在关联，且吡啶甲酸铬具有增强胰岛素的作用。
在这项双盲、多中心、为期8周的重复研究中，113名成年非典型抑郁症门诊患者按2:1随机分组，分别接受由吡啶甲酸铬（CrPic）提供的每日600微克元素铬或安慰剂。主要疗效指标为29项汉密尔顿抑郁评定量表（HAM-D-29）和临床总体印象改善量表（CGI-I）。
113名随机分组患者中，110名（70名CrPic组，40名安慰剂组）构成意向性治疗（ITT）人群（即接受至少一剂研究药物并完成至少一次疗效评估），75名（50名CrPic组，25名安慰剂组）可进行评估（即服用至少80%的研究药物且无明显方案偏离）。在可评估人群中，平均年龄为46岁，69%为女性，81%为白种人，平均体重指数（BMI）为29.7。在ITT人群和可评估人群中，CrPic组与安慰剂组在主要疗效指标上均无显著差异，两组在治疗过程中HAM-D-29总分均较基线有显著改善（p < 0.0001）。然而，在可评估人群中，CrPic组在HAM-D-29的4个项目上较基线相比与安慰剂组有显著改善：食欲增加、进食增多、渴望碳水化合物以及情绪的昼夜变化。对ITT人群中41名有强烈碳水化合物渴望的患者亚组（26名CrPic组，15名安慰剂组；平均BMI = 31.1）的数据进行补充分析显示，CrPic组患者在HAM-D-29总分上的反应显著大于安慰剂组（65%对33%；p < 0.
