![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
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 |
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 |
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.
|
Ages Eligible for Study: | 19 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: In Kyoon Lyoo, MD, PhD | +82-2-2073-3173 | inkylyoo@snu.ac.kr |
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 |
Study Chair: | Perry F Renshaw, MD, PhD | University of Utah |
Study Director: | In Kyoon Lyoo, Md, PhD | Seoul National University Hospital |
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 |
creatine augmentation major depressive disorder efficacy brain energy metabolism |
Depression Mental Disorders Mood Disorders Creatine Depressive Disorder, Major |
Dexetimide Depressive Disorder Citalopram Behavioral Symptoms |
Depression Mental Disorders Mood Disorders |
Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |