Creatine Augmentation in Veterans With SSRI-Resistant Major Depression

NCT01175616 | Withdrawn Phase 4 DMC

• 1 other identifier: 00041936
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

Major Depressive Disorder

Keywords

Depression; Adults

Outcome Measures

Primary Outcomes (1)

• Change in Montgomery-Asberg Depression Rating Scale (MADRS) Score

  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

  screening; baseline; weeks 1, 2, 4, 5, 8, and 10

Secondary Outcomes (1)

• Changes in 3T 31Phosphorus Magnetic Resonance Spectroscopy metabolites

  Baseline and 8 weeks

Study Arms (1)

Creatine

EXPERIMENTAL

Open-Label Active Treatment with Creatine 5 grams daily for 8 weeks.

Drug: Creatine

Interventions

Creatine DRUG

Oral Creatine 5 grams daily.

Also known as: Creapure

Creatine

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

Related Publications (4)

• Lyoo IK, Yoon S, Kim TS, Hwang J, Kim JE, Won W, Bae S, Renshaw PF. A randomized, double-blind placebo-controlled trial of oral creatine monohydrate augmentation for enhanced response to a selective serotonin reuptake inhibitor in women with major depressive disorder. Am J Psychiatry. 2012 Sep;169(9):937-945. doi: 10.1176/appi.ajp.2012.12010009.

  PMID: 22864465 BACKGROUND

• Kondo DG, Sung YH, Hellem TL, Fiedler KK, Shi X, Jeong EK, Renshaw PF. Open-label adjunctive creatine for female adolescents with SSRI-resistant major depressive disorder: a 31-phosphorus magnetic resonance spectroscopy study. J Affect Disord. 2011 Dec;135(1-3):354-61. doi: 10.1016/j.jad.2011.07.010. Epub 2011 Aug 9.

  PMID: 21831448 BACKGROUND

• Allen PJ, D'Anci KE, Kanarek RB, Renshaw PF. Sex-specific antidepressant effects of dietary creatine with and without sub-acute fluoxetine in rats. Pharmacol Biochem Behav. 2012 Jun;101(4):588-601. doi: 10.1016/j.pbb.2012.03.005. Epub 2012 Mar 10.

  PMID: 22429992 BACKGROUND

• Allen PJ. Creatine metabolism and psychiatric disorders: Does creatine supplementation have therapeutic value? Neurosci Biobehav Rev. 2012 May;36(5):1442-62. doi: 10.1016/j.neubiorev.2012.03.005. Epub 2012 Mar 24.

  PMID: 22465051 BACKGROUND

Related Links

• Research Website - University of Utah Brain Instititue

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Creatine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Guanidines; Amidines; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Perry F Renshaw, MD, PhD, MBA

  University of Utah

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 3, 2010
• First Posted: August 5, 2010
• Study Start: September 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: August 15, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share