Clinical trial NCT00729755: Creatine Augmentation Treatment in Major Depressive Disorder Subjects
Official title: Efficacy and Safety of Augmentation of Creatine for the Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Creatine
Augmentation
Major Depressive Disorder
Efficacy
Brain Energy Metabolism
Lead sponsor: Ewha Womans University
Sponsor class: OTHER
First posted: 2008-08-07
Enrollment: 59
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 19-65 year-old male or female
* Major depressive disorder diagnosed by SCID-IV
* Hamilton depression rating scale score \>= 16 at screening
* Written informed consent

Exclusion Criteria:

* Suicidal idea that needs hospitalization
* Any other axis I psychiatric disorder
* Neurologic disease (eg., epilepsy, infarct, multiple sclerosis, brain tumor)
* IQ below 80
* Inflammatory disease including autoimmune disease
* Taking anti-inflammatory medication
* Serious physical disease
* Substance abuse or dependence history in recent 6 months
* Pregnant or having plan to be pregnant

Primary outcomes:
measure: Hamilton depression rating scale
timeFrame: baseline, 1st, 2nd, 4th, 8th week
Secondary outcomes:
measure: Clinical global impression scale
timeFrame: baseline, 1st, 2nd, 4th, 8th week
measure: Side effects assessment: the interview and examination by the investigators
timeFrame: baseline, 1st, 2nd, 4th, 8th week
measure: Serum inflammatory mediators (eg., IL-1, -2, PGE2, interferon gamma) level
timeFrame: baseline, 8th week
measure: Serum creatinine level
timeFrame: baseline, 2nd, 8th week
measure: Brain MRI
timeFrame: baseline, 8th week
measure: Montgomery-Asberg depression scale
timeFrame: baseline, 1st, 2nd, 4th, 8th week
Other outcomes:
Locations:
city: Bucheon City
country: Korea, Republic of
facility: Holy Family Hospital
state: Kyunggi-Do
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: St. Paul's Hospital
Study officials:
affiliation: University of Utah
name: Perry F Renshaw, MD, PhD
role: STUDY_CHAIR
affiliation: Ewha Womans University
name: In Kyoon Lyoo, MD, PhD, MMS
role: STUDY_DIRECTOR
References:
citation: Yoon S, Kim JE, Hwang J, Kim TS, Kang HJ, Namgung E, Ban S, Oh S, Yang J, Renshaw PF, Lyoo IK. Effects of Creatine Monohydrate Augmentation on Brain Metabolic and Network Outcome Measures in Women With Major Depressive Disorder. Biol Psychiatry. 2016 Sep 15;80(6):439-447. doi: 10.1016/j.biopsych.2015.11.027. Epub 2015 Dec 15.
citation: Lyoo IK, Yoon S, Kim TS, Hwang J, Kim JE, Won W, Bae S, Renshaw PF. A randomized, double-blind placebo-controlled trial of oral creatine monohydrate augmentation for enhanced response to a selective serotonin reuptake inhibitor in women with major depressive disorder. Am J Psychiatry. 2012 Sep;169(9):937-945. doi: 10.1176/appi.ajp.2012.12010009.