Given 1) the established safety with short-term or long-term supplementation of Cr, 2) its potential usefulness in improving brain energy metabolism, 3) the reported abnormality in brain energy metabolism in MDD subjects, and 4) plausible association between depression and inflammatory mediators, we hypothesize that oral Cr augmentation will help reduce symptoms in MDD patients as well as normalize a deficit in brain energy metabolism and that improvement of MDD and brain energy metabolism will be correlated with inflammatory mediators changes. In this study, we plan to conduct an randomized, double-blind, placebo-controlled augmentation study with creatine in addition to escitalopram. We will assess the efficacy and safety of the Cr augmentation and evaluate changes relevant to brain energy metabolism and inflammatory mediators.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
59
In addition to 10-20mg escitalopram, the subjects will be given total 3 gram of creatine (500mg/capsule) a day in first week and then, 5 gram a day in the rest of the weeks.
In addition to 10-20mg escitalopram, the subjects will be given total 6 capsules of placebo (equal quantities to those of creatine group) a day in first week and then, 10 capsules a day in the rest of the weeks.
Holy Family Hospital
Bucheon-si, Gyeonggi-do, South Korea
Seoul St. Mary's Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
St. Paul's Hospital
Seoul, South Korea
Hamilton depression rating scale
Time frame: baseline, 1st, 2nd, 4th, 8th week
Clinical global impression scale
Time frame: baseline, 1st, 2nd, 4th, 8th week
Side effects assessment: the interview and examination by the investigators
Time frame: baseline, 1st, 2nd, 4th, 8th week
Serum inflammatory mediators (eg., IL-1, -2, PGE2, interferon gamma) level
Time frame: baseline, 8th week
Serum creatinine level
Time frame: baseline, 2nd, 8th week
Brain MRI
Time frame: baseline, 8th week
Montgomery-Asberg depression scale
Time frame: baseline, 1st, 2nd, 4th, 8th week
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