Creatine Augmentation in Veterans With SSRI-Resistant Major Depression
The purpose of this study is to determine whether creatine will be helpful as an adjunctive treatment for treatment-resistant major depressive disorder (MDD) in female and male Veterans. We hypothesize that Veterans receiving creatine will show decreased depressive symptoms as measured by the Montgomery-Asberg Depression Rating Scale (MADRS). We will also use 31-Phosphorus Magnetic Resonance Spectroscopy (31-P MRS) brain scans to compare levels of neurochemicals related to energy metabolism in the brain, before-and-after treatment with creatine, and between healthy controls and MDD participants.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Creatine Augmentation in Female & Male Veterans With Selective Serotonin Reuptake Inhibitor-Resistant Major Depressive Disorder|
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) Score [ Time Frame: screening; baseline; weeks 1, 2, 4, 5, 8, and 10 ] [ Designated as safety issue: No ]The primary clinical outcome measure will be the change in MADRS; response will be defined as a 50% or greater decrease in MADRS score from baseline and a Clinical Global Impression Scale (CGI) improvement score of 1 or 2
- Changes in 3T 31Phosphorus Magnetic Resonance Spectroscopy metabolites [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]The primary neuroimaging outcome measures will be changes in 3T 31P-MRS metabolites (PCr and β-NTP) globally and in the anterior cingulate cortex
|Study Start Date:||September 2012|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
No Intervention: Healthy Control
20 adult male veterans free from psychiatric disorders or uncontrolled medical illnesses will be recruited as healthy controls. They will not receive creatine treatment.
20 adult male veterans with SSRI-resistant major depression will be treated with Creatine 5 grams per day for eight weeks.
Creatine will be given at a dose of 5 grams per day to adult male veterans with SSRI-resistant depression for eight weeks. Creatine is dispensed as a powder.
Other Name: Creapure
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01175616
|Study Director:||Perry Renshaw, MD, PhD, MBA||University of Utah|