Creatine Augmentation Treatment in Major Depressive Disorder Subjects - Full Text View

Sponsors and Collaborators:	Seoul National University Hospital Precision Human BioLaboratory Hallym University Medical Center Bucheon Holy Family Hospital Chung-Ang University
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00729755

Purpose

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 current study, we plan to conduct an randomized, double-blind, placebo-controlled augmentation study with creatine in addition to escitalopram for treating 50 MDD subjects. We will assess the efficacy and safety of the Cr augmentation and evaluate changes relevant to brain energy metabolism and inflammatory mediators.

Condition	Intervention
Depression	Dietary Supplement: Creatine monohydrate Dietary Supplement: Placebo

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Efficacy and Safety of Augmentation of Creatine for the Patients With Major Depressive Disorder

Resource links provided by NLM:

MedlinePlus related topics: Depression Dietary Supplements Diets

Drug Information available for: Creatine Creatine monohydrate

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:

Hamilton Depression Rating Scale [ Time Frame: baseline, 1st, 2nd, 4th, 8th week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Clinical Global Impression Scale [ Time Frame: Baseline, 1st, 2nd, 4th, 8th week ] [ Designated as safety issue: No ]
UKU side effect rating scale [ Time Frame: Baseline, 1st, 2nd, 4th, 8th week ] [ Designated as safety issue: Yes ]
Serum inflammatory mediators (eg., IL-1, -2, PGE2, interferon gamma) level [ Time Frame: baseline, 8th week ] [ Designated as safety issue: No ]
Serum creatinine level [ Time Frame: baseline, 2nd, 8th week ] [ Designated as safety issue: Yes ]
Energy metabolism measured by 31P-MRS [ Time Frame: baseline, 8th week ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	August 2008
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Creatine: Experimental The subjects with major depressive disorder, treated with creatine in addition to escitalopram	Dietary Supplement: Creatine monohydrate In addition to 10mg 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.
Placebo: Placebo Comparator The subjects with major depressive disorder, treated with placebo in addition to escitalopram	Dietary Supplement: Placebo In addition to 10mg 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.

Eligibility

Ages Eligible for Study:	19 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729755

Contacts

Contact: In Kyoon Lyoo, MD, PhD

+82-2-2073-3173

inkylyoo@snu.ac.kr

Locations

Korea, Republic of
Seoul National University Hospital	Recruiting
Seoul, Korea, Republic of
Contact: In Kyoon Lyoo, MD, PhD +82-2-2072-3173 inkylyoo@snu.ac.kr
Sub-Investigator: Jaeuk Hwang, MD
Sub-Investigator: Jieun Kim, MD
St.Paul's Hospital	Recruiting
Seoul, Korea, Republic of
Contact: Sujung Yoon, MD +82-10-4134-2228 sujungjyoon@gmail.com
Hangang Sacred Heart Hospital	Recruiting
Seoul, Korea, Republic of
Contact: Byung Joo Ham, MD, PhD +82-10-8931-7850 hambj@chol.com
Daegu Catholic University Medical Center	Recruiting
Daegu, Korea, Republic of
Contact: Tae-Young Choi, MD +82-19-377-1552 dr.tyoungchoi@gmail.com
Holy Family Hospital	Recruiting
Bucheon, Korea, Republic of
Contact: Tae-Suk Kim, MD +82-11-724-4776 bluenote@catholic.ac.kr
Chung-Ang Univsersity Hospital	Recruiting
Seoul, Korea, Republic of
Contact: Doug Hyun Han, MD +82-10-5043-0876 hduk@yahoo.com

Sponsors and Collaborators

Seoul National University Hospital

Precision Human BioLaboratory

Hallym University Medical Center

Bucheon Holy Family Hospital

Chung-Ang University

Investigators

Study Chair:	Perry F Renshaw, MD, PhD	University of Utah
Study Director:	In Kyoon Lyoo, Md, PhD	Seoul National University Hospital

More Information

No publications provided

Responsible Party:	Seoul National Univsersity Hospital ( In Kyoon Lyoo )
Study ID Numbers:	BIC-08DE00101B
Study First Received:	August 4, 2008
Last Updated:	October 18, 2008
ClinicalTrials.gov Identifier:	NCT00729755 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:

creatine
augmentation
major depressive disorder
efficacy
brain energy metabolism

Study placed in the following topic categories:

Depression
Mental Disorders
Mood Disorders
Creatine
Depressive Disorder, Major

Dexetimide
Depressive Disorder
Citalopram
Behavioral Symptoms

Additional relevant MeSH terms:

Depression
Mental Disorders
Mood Disorders

Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 02, 2009