Study M330

Study name

Yoon SJ 2016

Title

Effects of creatine monohydrate augmentation on brain metabolic and network outcome measures in women with major depressive disorder

Overall design

In this randomized, double-blind, placebo-controlled trial, 52 women with major depressive disorder (MDD) were assigned to receive either creatine augmentation or placebo augmentation of escitalopram; subjects (depression group, n = 34) participated in multimodal neuroimaging assessments at baseline and week 8. Age-matched healthy women (control group, n = 39) were also assessed twice at the same intervals. After baseline acquisitions of MRI and magnetic resonance spectroscopy (MRS) data, women with MDD were randomly assigned to receive either escitalopram plus creatine or escitalopram plus placebo for 8 weeks. The dosing schedule of creatine administration was 3 g daily for the first week and then 5 g daily for the remaining 7 weeks of treatment. The initial dose of escitalopram was 10 mg daily for the first week, and subsequent doses could be increased up to 20 mg daily for the following 7 weeks according to the clinician's judgment. Of 34 women with MDD who underwent baseline MRI/MRS scanning, 27 patients (escitalopram + creatine group, n = 11, and escitalopram + placebo group, n = 16) completed the trial and follow-up MRI/MRS scanning. Of 39 healthy women who underwent the baseline MRI/MRS scanning, 36 completed follow-up MRI/MRS scanning after 8 weeks. Metabolic and network outcomes were measured for changes in prefrontal N-acetylaspartate and changes in rich club hub connections of the structural brain network using proton magnetic resonance spectroscopy and diffusion tensor imaging, respectively. Metabolite quantification was reported relative to brain water concentration.

Study Type

Type1;

Type2;

Data available

Unavailable

Organism

Human;

Categories of depression

Depressive disorder; Depression; Depression;

Criteria for depression

DSM-IV diagnosed MDD, HAMD-17 >= 16

Sample size

73

Tissue

Central; Brain; Prefrontal cortex;

Platform

MRS; MRS: 1.5 Tesla whole body imaging system (Signa HDx; GE Healthcare, Milwaukee, Wisconsin);

PMID

26822799

DOI

10.1016/j.biopsych.2015.11.027

Citation

Yoon S, Kim JE, Hwang J, et al. Effects of creatine monohydrate augmentation on brain metabolic and network outcome measures in women with major depressive disorder. Biol Psychiatry 2016;80(6):439-47.

Metabolite

N-Acetyl-L-aspartic acid;