Creatine Augmentation Treatment in Major Depressive Disorder Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
In Kyoon Lyoo, MD, PhD, MMS, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00729755
First received: August 4, 2008
Last updated: June 27, 2012
Last verified: June 2012
  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 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.


Condition Intervention
Major Depressive Disorder
Dietary Supplement: Creatine monohydrate
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Augmentation of Creatine for the Patients With Major Depressive Disorder

Resource links provided by NLM:


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 ]
  • Side effects assessment: the interview and examination by the investigators [ 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 ]
  • Brain MRI [ Time Frame: baseline, 8th week ] [ Designated as safety issue: No ]
  • Montgomery-Asberg depression scale [ Time Frame: baseline, 1st, 2nd, 4th, 8th week ] [ Designated as safety issue: No ]

Enrollment: 59
Study Start Date: August 2008
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Creatine
The subjects with major depressive disorder, treated with creatine in addition to escitalopram
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.
Placebo Comparator: Placebo
The subjects with major depressive disorder, treated with placebo in addition to escitalopram
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Korea, Republic of
Holy Family Hospital
Bucheon City, Kyunggi-Do, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 137-701
St. Paul's Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Study Chair: Perry F Renshaw, MD, PhD University of Utah
Study Director: In Kyoon Lyoo, MD, PhD, MMS Seoul National University Hospital
  More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: In Kyoon Lyoo, MD, PhD, MMS, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00729755     History of Changes
Other Study ID Numbers: BIC-08DE00101B
Study First Received: August 4, 2008
Last Updated: June 27, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:
Creatine
Augmentation
Major Depressive Disorder
Efficacy
Brain Energy Metabolism

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014