Creatine Augmentation Treatment in Major Depressive Disorder Subjects

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00729755
• Other study ID #: BIC-08DE00101B
• Status: Completed
• Phase: N/A
• First received: August 4, 2008
• Last updated: July 3, 2017
• Start date: August 2008
• Est. completion date: May 2012

Study information

• Verified date: July 2017
• Source: Ewha Womans University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Intervention

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
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.

Locations

Country	Name	City	State
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	St. Paul's Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Ewha Womans University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton depression rating scale		baseline, 1st, 2nd, 4th, 8th week
Secondary	Clinical global impression scale		baseline, 1st, 2nd, 4th, 8th week
Secondary	Side effects assessment: the interview and examination by the investigators		baseline, 1st, 2nd, 4th, 8th week
Secondary	Serum inflammatory mediators (eg., IL-1, -2, PGE2, interferon gamma) level		baseline, 8th week
Secondary	Serum creatinine level		baseline, 2nd, 8th week
Secondary	Brain MRI		baseline, 8th week
Secondary	Montgomery-Asberg depression scale		baseline, 1st, 2nd, 4th, 8th week