Creatine Augmentation in Veterans With SSRI-Resistant Major Depression

• Status: Withdrawn
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Utah
• Treatments: Serotonin Uptake Inhibitors

Criteria

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.