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A Double-Blind, Placebo-Controlled, Exploratory Trial of Chromium Picolinate in

Atypical Depression: Effect on Carbohydrate Craving.

Journal of Psychiatric Practice. 11(5):302-314, September 2005.

DOCHERTY, JOHN P. MD; SACK, DAVID A. MD; ROFFMAN, MARK PhD; FINCH, MANLEY;

KOMOROWSKI, JAMES R. MS

Abstract:

Background: 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.

Methods: In this double-blind, multicenter, 8-week replication study, 113 adult

outpatients with atypical depression were randomized 2:1 to receive 600

[mu]g/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).

Results: 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.

Limitations: 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.

Conclusions: 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 [mu]g 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.

© 2005 Lippincott & Wilkins, Inc.

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