Creatine Augmentation in Veterans With Selective Serotonin Reuptake Inhibitor (SSRI)-Resistant Major Depression
This study is currently recruiting participants.
Verified October 2011 by University of Utah
Sponsor:
University of Utah
Information provided by (Responsible Party):
Doug Kondo, University of Utah
ClinicalTrials.gov Identifier:
NCT01175616
First received: August 3, 2010
Last updated: October 20, 2011
Last verified: October 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The purpose of this study is to determine whether creatine will be helpful as an adjunctive treatment for SSRI-resistant depression in male veterans. We hypothesize that male veterans receiving creatine will show decreased depressive symptoms as measured by the Montgomery-Asberg Depression Rating Scale. We will also use 31-Phosphorus Magnetic Resonance Spectroscopy (31-P MRS) scans to compare levels of metabolites in the brain before and after treatment with creatine as well as between healthy controls and major depression participants.
| Condition | Intervention | Phase |
|---|---|---|
|
Major Depressive Disorder |
Drug: Creatine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Creatine Augmentation in Veterans With SSRI-Resistant Major Depression |
Resource links provided by NLM:
Further study details as provided by University of Utah:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 40 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
|
|
Experimental: Creatine
20 adult male veterans with SSRI-resistant major depression will be treated with Creatine 5 grams per day for eight weeks.
|
Drug: Creatine
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
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria for Major Depressive Disorder Participants:
- Must meet DSM-IV TR criteria for MDD, with current depressive episode lasting 4 weeks or greater.
- Age 18-55 years
- Male
- Montgomery-Asberg Depression Rating Scale (MADRS) of 18 or greater
- Adequate trial of current SSRI antidepressant treatment, with no change in dose for 4 weeks for greater prior to baseline MRI/MRS scan
- Minimal or no response to current antidepressant medication
Exclusion Criteria for Major Depressive Disorder Participants:
- Unstable co-morbid medical, neurologic, or psychiatric illness
- Clinically significant substance use disorder
- Significant risk of suicide, as defined by score of 4 or greater on item 10 of the MADRS or in the clinical judgment of the study physician
- Inability to give informed consent
- Contraindication to MRI (e.g., pacemaker, ferromagnetic implants in the body, claustrophobia)
- Individuals with known pre-existing renal disease or who are found to have proteinuria or microalbuminuria at baseline screening
- History of hypersensitivity to creatine
Inclusion Criteria for Control Participants:
- Physically and mentally healthy
- Age 18-55 years
- Male
Exclusion Criteria for Control Subjects:
- Any history of psychiatric illness or clinically significant substance use disorder
- Any significant medical or neurological condition which is likely to impact the central nervous system and/or affect the results of MRS imaging
- Inability to give informed consent
- Any medications which are likely to affect the results of MRS imaging as determined by the PI
- Contraindication to MRI (e.g., pacemaker, ferromagnetic implants in the body, claustrophobia)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01175616
Contacts
| Contact: Kristen Fiedler, BS | 801-587-0325 | kristen.fiedler@utah.edu |
| Contact: Douglas Kondo, MD | 801-587-1422 | doug.kondo@hsc.utah.edu |
Locations
| United States, Utah | |
| George E. Wahlen Veterans Affairs Medical Center | Recruiting |
| Salt Lake City, Utah, United States, 84148 | |
| Principal Investigator: Doug Kondo, MD | |
| Sub-Investigator: Paul Carlson, MD | |
Sponsors and Collaborators
University of Utah
Investigators
| Study Director: | Perry Renshaw, MD, PhD, MBA | University of Utah |
More Information
Publications:
| Responsible Party: | Doug Kondo, MD, University of Utah |
| ClinicalTrials.gov Identifier: | NCT01175616 History of Changes |
| Other Study ID Numbers: | 00041936 |
| Study First Received: | August 3, 2010 |
| Last Updated: | October 20, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Utah:
|
Depression Males Adults |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders Mental Disorders Serotonin Uptake Inhibitors |
Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013