Creatine Augmentation Treatment in Major Depressive Disorder Subjects
- Conditions
- Major Depressive Disorder
- Interventions
- Dietary Supplement: PlaceboDietary Supplement: Creatine monohydrate
- Registration Number
- NCT00729755
- Lead Sponsor
- Ewha Womans University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo The subjects with major depressive disorder, treated with placebo in addition to escitalopram Creatine Creatine monohydrate The subjects with major depressive disorder, treated with creatine in addition to escitalopram
- Primary Outcome Measures
Name Time Method Hamilton depression rating scale baseline, 1st, 2nd, 4th, 8th week
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (4)
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, Korea, Republic of