Status:
WITHDRAWN
Creatine Augmentation in Veterans With SSRI-Resistant Major Depression
Lead Sponsor:
University of Utah
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE4
Brief Summary
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 hypothesiz...
Detailed Description
This is an open-label clinical trial of the investigational drug creatine for augmentation treatment of female and male Veterans, ages 18-55, with Major Depressive Disorder (MDD) who have failed to re...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Major Depressive Disorder Participants:
- Must be a U.S. military Veteran from 18-55 years of age.
- Must meet DSM criteria for Major Depressive Disorder (MDD).
- Current depressive episode duration of 4 weeks or longer.
- Montgomery-Asberg Depression Rating Scale (MADRS) score of 18 or greater.
- Adequate trial of an SSRI antidepressant, in terms of dosing and duration.
- No change in SSRI dose, for 4 weeks prior to the baseline brain scan.
- Partial or non-responder to current SSRI pharmacotherapy.
- Exclusion Criteria for Major Depressive Disorder Participants:
- Primary psychotic or schizophrenia-spectrum disorder.
- Unstable co-morbid medical, neurologic, or psychiatric illness.
- Clinically significant substance use disorder.
- Significant risk of suicide, in the clinical judgment of the study physician.
- Inability to provide informed consent.
- Contraindication to brain scanning (e.g., pacemaker, ferromagnetic implant).
- Pre-existing renal disease, with proteinuria at baseline.
- History of hypersensitivity to creatine.
- Concurrent participation in another FDA-sanctioned clinical trial.
Exclusion
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01175616
Start Date
September 1 2012
End Date
April 1 2014
Last Update
August 15 2016
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