Creatine Augmentation Treatment in Major Depressive Disorder Subjects

Study Overview
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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.

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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Dietary Supplement: Creatine monohydrate
* Dietary Supplement: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Creatine<br>The subjects with major depressive disorder, treated with creatine in addition to escitalopram | Dietary Supplement: Creatine monohydrate<br>* 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.<br>|
| Placebo Comparator: Placebo<br>The subjects with major depressive disorder, treated with placebo in addition to escitalopram | Dietary Supplement: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton depression rating scale |  | baseline, 1st, 2nd, 4th, 8th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Montgomery-Asberg depression scale |  | baseline, 1st, 2nd, 4th, 8th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Creatine, Augmentation, Major Depressive Disorder, Efficacy, Brain Energy Metabolism