NCT00729755

Creatine Augmentation Treatment in Major Depressive Disorder Subjects

Efficacy and Safety of Augmentation of Creatine for the Patients With Major Depressive Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: Ewha Womans University · Academic / Other
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Creatine monohydrate	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.
DIETARY_SUPPLEMENT	Placebo	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.

Timeline

• Start date: 2008-08-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2008-08-07
• Last updated: 2017-07-05

Locations

4 sites across 1 country: South Korea