Creatine Augmentation Treatment in Major Depressive Disorder Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2012-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Creatine

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

Group Type EXPERIMENTAL

Creatine monohydrate

Intervention Type 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

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type 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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No