Skip to main content
OpenTrials
Completed

NCT Number: NCT00729755

Creatine Augmentation Treatment in Major Depressive Disorder Subjects

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Holy Family Hospital, Bucheon-si, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Creatine Monohydrate

Dietary Supplement

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

Dietary Supplement

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.

Primary outcomes

  1. Hamilton depression rating scale

    Time frame: baseline, 1st, 2nd, 4th, 8th week

Secondary outcomes

  1. Clinical global impression scale

    Time frame: baseline, 1st, 2nd, 4th, 8th week

  2. Side effects assessment: the interview and examination by the investigators

    Time frame: baseline, 1st, 2nd, 4th, 8th week

  3. Serum inflammatory mediators (eg., IL-1, -2, PGE2, interferon gamma) level

    Time frame: baseline, 8th week

  4. Serum creatinine level

    Time frame: baseline, 2nd, 8th week

  5. Brain MRI

    Time frame: baseline, 8th week

  6. Montgomery-Asberg depression scale

    Time frame: baseline, 1st, 2nd, 4th, 8th week

Sponsors and collaborators

Lead sponsor

Ewha Womans University

Other

Registry information

Official study title

Efficacy and Safety of Augmentation of Creatine for the Patients With Major Depressive Disorder

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Aug 7, 2008
Registry last updated
Jul 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.