Creatine Augmentation Treatment in Major Depressive Disorder Subjects

Ewha Womans University

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Dietary Supplement: Creatine monohydrate; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00729755

BIC-08DE00101B

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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59 participants in 2 patient groups, including a placebo group

Creatine

Experimental group

Description:

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

Treatment:

Dietary Supplement: Creatine monohydrate

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo