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Creatine Augmentation Treatment in Major Depressive Disorder Subjects

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ClinicalTrials.gov Identifier: NCT00729755
Recruitment Status : Completed
First Posted : August 7, 2008
Last Update Posted : July 5, 2017
Sponsor:
Information provided by (Responsible Party):
In Kyoon Lyoo, Ewha Womans University

Tracking Information
First Submitted Date  ICMJE August 4, 2008
First Posted Date  ICMJE August 7, 2008
Last Update Posted Date July 5, 2017
Study Start Date  ICMJE August 2008
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2008)
Hamilton depression rating scale [ Time Frame: baseline, 1st, 2nd, 4th, 8th week ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00729755 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2012)
  • Clinical global impression scale [ Time Frame: baseline, 1st, 2nd, 4th, 8th week ]
  • Side effects assessment: the interview and examination by the investigators [ Time Frame: baseline, 1st, 2nd, 4th, 8th week ]
  • Serum inflammatory mediators (eg., IL-1, -2, PGE2, interferon gamma) level [ Time Frame: baseline, 8th week ]
  • Serum creatinine level [ Time Frame: baseline, 2nd, 8th week ]
  • Brain MRI [ Time Frame: baseline, 8th week ]
  • Montgomery-Asberg depression scale [ Time Frame: baseline, 1st, 2nd, 4th, 8th week ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 4, 2008)
  • Clinical global impression scale [ Time Frame: baseline, 1st, 2nd, 4th, 8th week ]
  • UKU side effect rating scale [ Time Frame: baseline, 1st, 2nd, 4th, 8th week ]
  • Serum inflammatory mediators (eg., IL-1, -2, PGE2, interferon gamma) level [ Time Frame: baseline, 8th week ]
  • Serum creatinine level [ Time Frame: baseline, 2nd, 8th week ]
  • Energy metabolism measured by 31P-MRS [ Time Frame: baseline, 8th week ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Creatine Augmentation Treatment in Major Depressive Disorder Subjects
Official Title  ICMJE Efficacy and Safety of Augmentation of Creatine for the Patients With Major Depressive Disorder
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Creatine
    The subjects with major depressive disorder, treated with creatine in addition to escitalopram
    Intervention: Dietary Supplement: Creatine monohydrate
  • Placebo Comparator: Placebo
    The subjects with major depressive disorder, treated with placebo in addition to escitalopram
    Intervention: Dietary Supplement: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 27, 2012)
59
Original Estimated Enrollment  ICMJE
 (submitted: August 4, 2008)
50
Actual Study Completion Date  ICMJE May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00729755
Other Study ID Numbers  ICMJE BIC-08DE00101B
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party In Kyoon Lyoo, Ewha Womans University
Study Sponsor  ICMJE Ewha Womans University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Perry F Renshaw, MD, PhD University of Utah
Study Director: In Kyoon Lyoo, MD, PhD, MMS Ewha Womans University
PRS Account Ewha Womans University
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP