Major Depressive Disorder
Conditions
Keywords
Creatine, Augmentation, Major Depressive Disorder, Efficacy, Brain Energy Metabolism
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.
Interventions
DIETARY_SUPPLEMENTCreatine 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.
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
Ewha Womans University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton depression rating scale | baseline, 1st, 2nd, 4th, 8th week |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Clinical global impression scale | baseline, 1st, 2nd, 4th, 8th week |
| Brain MRI | baseline, 8th week |
| Montgomery-Asberg depression scale | baseline, 1st, 2nd, 4th, 8th week |
| Serum creatinine level | baseline, 2nd, 8th week |
Countries
South Korea
Outcome results
None listed