Creatine Augmentation Treatment in Major Depressive Disorder Subjects

Last updated: July 3, 2017
Sponsor: Ewha Womans University
Overall Status: Completed

Phase

N/A

Condition

Depression

Depression (Adult And Geriatric)

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT00729755
BIC-08DE00101B
  • Ages 19-65
  • All Genders

Study 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

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

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

Study Design

Total Participants: 59
Study Start date:
August 01, 2008
Estimated Completion Date:
May 31, 2012

Connect with a study center

  • Holy Family Hospital

    Bucheon City, Kyunggi-Do
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul St. Mary's Hospital

    Seoul, 137-701
    Korea, Republic of

    Site Not Available

  • St. Paul's Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

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