Creatine Augmentation Treatment in Major Depressive Disorder Subjects

NCT00729755 | Completed DMC

• 1 other identifier: BIC-08DE00101B
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 4

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.

Conditions

Major Depressive Disorder

Keywords

Creatine; Augmentation; Major Depressive Disorder; Efficacy; Brain Energy Metabolism

Outcome Measures

Primary Outcomes (1)

• Hamilton depression rating scale

  baseline, 1st, 2nd, 4th, 8th week

Secondary Outcomes (6)

• Clinical global impression scale

  baseline, 1st, 2nd, 4th, 8th week

• Side effects assessment: the interview and examination by the investigators

  baseline, 1st, 2nd, 4th, 8th week

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

  baseline, 8th week

• Serum creatinine level

  baseline, 2nd, 8th week

• Brain MRI

  baseline, 8th week

Study Arms (2)

Creatine

EXPERIMENTAL

The subjects with major depressive disorder, treated with creatine in addition to escitalopram

Dietary Supplement: Creatine monohydrate

Placebo

PLACEBO COMPARATOR

The subjects with major depressive disorder, treated with placebo in addition to escitalopram

Dietary Supplement: Placebo

Interventions

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.

Creatine

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.

Placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• year-old male or female
• Major depressive disorder diagnosed by SCID-IV
• Hamilton depression rating scale score \>= 16 at screening
• Written informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Ewha Womans University: lead

Study Sites (4)

Holy Family Hospital

Bucheon-si, Gyeonggi-do, South Korea

Location

Seoul St. Mary's Hospital

Seoul, 137-701, South Korea

Location

Seoul National University Hospital

Seoul, South Korea

Location

St. Paul's Hospital

Seoul, South Korea

Location

Related Publications (2)

• Yoon S, Kim JE, Hwang J, Kim TS, Kang HJ, Namgung E, Ban S, Oh S, Yang J, Renshaw PF, Lyoo IK. Effects of Creatine Monohydrate Augmentation on Brain Metabolic and Network Outcome Measures in Women With Major Depressive Disorder. Biol Psychiatry. 2016 Sep 15;80(6):439-447. doi: 10.1016/j.biopsych.2015.11.027. Epub 2015 Dec 15.

  PMID: 26822799 DERIVED

• Lyoo IK, Yoon S, Kim TS, Hwang J, Kim JE, Won W, Bae S, Renshaw PF. A randomized, double-blind placebo-controlled trial of oral creatine monohydrate augmentation for enhanced response to a selective serotonin reuptake inhibitor in women with major depressive disorder. Am J Psychiatry. 2012 Sep;169(9):937-945. doi: 10.1176/appi.ajp.2012.12010009.

  PMID: 22864465 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Creatine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Perry F Renshaw, MD, PhD

  University of Utah

  STUDY CHAIR

• In Kyoon Lyoo, MD, PhD, MMS

  Ewha Womans University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 4, 2008
• First Posted: August 7, 2008
• Study Start: August 1, 2008
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: July 5, 2017

Record last verified: 2017-07

Locations

KR (4)