NCT03433651

Brief Summary

This study involves the use of an investigational drug called Creatine Monohydrate. This means that the drug has not yet been approved by the Food \& Drug Administration (FDA) for treatment of altitude-induced depression. However, the FDA has not objected to its use to study its safety and effectiveness for preventing altitude-induced depression. This study will help find out what effects, good and/or bad, Creatine Monohydrate has on treating symptoms for altitude-induced depression. Creatine Monohydrate is believed to have an effect on improving symptoms of depression. The safety of Creatine Monohydrate in humans has been tested in prior research studies; however, some side effects may not yet be known.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2019

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

6 days

First QC Date

February 8, 2018

Last Update Submit

September 3, 2024

Conditions

Depression

Keywords

depression

Outcome Measures

Primary Outcomes (2)

  • Patient Health Questionnaire-9 (PHQ-9)

    Questionnaire

    5 repeated measurements over the 120-day course of the study

  • Generalized Anxiety Disorder 7 (GAD-7)

    Questionnaire

    5 repeated measurements over the 120-day course of the study

Study Arms (2)

creatine monohydrate

EXPERIMENTAL

Experimental will take by mouth 5 grams a day of creatine monohydrate powder. Subjects will be given a 30 day supply of the study powder. They will be reminded to take the powder as instructed.

Drug: Creatine monohydrate

Placebo

PLACEBO COMPARATOR

Placebo will take by mouth 5 grams a day of placebo powder. Subjects will be given a 30 day supply of the study powder. They will be reminded to take the powder as instructed.

Drug: Placebo

Interventions

Creatine monohydrateDRUG

Subjects will take by mouth 5 grams a day of creatine monohydrate powder.

Also known as: creapure
creatine monohydrate
PlaceboDRUG

Subjects will take by mouth 5 grams a day of placebo powder.

Also known as: maltodextrin
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and Female Active Duty members and DoD beneficiaries ages 18-65
  • Moved to CREECH AFB from an altitude of less than 2,000 feet within the last month

You may not qualify if:

  • Preexisting depression as noted in a review of their medical record or on their PHQ9 (score of 10 or greater)
  • Preexisting anxiety as noted in a review of their medical record or on their GAD 7 (score of 10 or greater)
  • Clinical or laboratory evidence of liver disease.
  • Serum creatinine \>1.5
  • Existing kidney disease
  • Existing Type I or Type II Diabetes Mellitus
  • Taking creatine as a dietary supplement
  • Moved to CREECH AFB from an altitude of greater than 2000 feet
  • Pregnant, breast feeding, or trying to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mike O'Callaghan Military Medical Center

Las Vegas, Nevada, 89191, United States

Location

Related Publications (17)

  • Kessler RC, Chiu WT, Demler O, Merikangas KR, Walters EE. Prevalence, severity, and comorbidity of 12-month DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):617-27. doi: 10.1001/archpsyc.62.6.617.

    PMID: 15939839BACKGROUND

  • DelMastro K, Hellem T, Kim N, Kondo D, Sung YH, Renshaw PF. Incidence of major depressive episode correlates with elevation of substate region of residence. J Affect Disord. 2011 Mar;129(1-3):376-9. doi: 10.1016/j.jad.2010.10.001. Epub 2010 Nov 11.

    PMID: 21074272BACKGROUND

  • Bardwell WA, Ensign WY, Mills PJ. Negative mood endures after completion of high-altitude military training. Ann Behav Med. 2005 Feb;29(1):64-9. doi: 10.1207/s15324796abm2901_9.

    PMID: 15677302BACKGROUND

  • 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: 22864465BACKGROUND

  • Armed Forces Health Surveillance Center (AFHSC). Absolute and relative morbidity burdens attributable to various illnesses and injuries, non-service member beneficiaries of the Military Health System, 2014. MSMR. 2015 Apr;22(4):27-34. No abstract available.

    PMID: 25923401BACKGROUND

  • Brenner B, Cheng D, Clark S, Camargo CA Jr. Positive association between altitude and suicide in 2584 U.S. counties. High Alt Med Biol. 2011 Spring;12(1):31-5. doi: 10.1089/ham.2010.1058. Epub 2011 Jan 7.

    PMID: 21214344BACKGROUND

  • Kim N, Mickelson JB, Brenner BE, Haws CA, Yurgelun-Todd DA, Renshaw PF. Altitude, gun ownership, rural areas, and suicide. Am J Psychiatry. 2011 Jan;168(1):49-54. doi: 10.1176/appi.ajp.2010.10020289. Epub 2010 Sep 15.

    PMID: 20843869BACKGROUND

  • Drevets WC. Prefrontal cortical-amygdalar metabolism in major depression. Ann N Y Acad Sci. 1999 Jun 29;877:614-37. doi: 10.1111/j.1749-6632.1999.tb09292.x.

    PMID: 10415674BACKGROUND

  • Rango M, Castelli A, Scarlato G. Energetics of 3.5 s neural activation in humans: a 31P MR spectroscopy study. Magn Reson Med. 1997 Dec;38(6):878-83. doi: 10.1002/mrm.1910380605.

    PMID: 9402187BACKGROUND

  • Shi XF, Carlson PJ, Kim TS, Sung YH, Hellem TL, Fiedler KK, Kim SE, Glaeser B, Wang K, Zuo CS, Jeong EK, Renshaw PF, Kondo DG. Effect of altitude on brain intracellular pH and inorganic phosphate levels. Psychiatry Res. 2014 Jun 30;222(3):149-56. doi: 10.1016/j.pscychresns.2014.04.002. Epub 2014 Apr 13.

    PMID: 24768210BACKGROUND

  • Lyoo IK, Kong SW, Sung SM, Hirashima F, Parow A, Hennen J, Cohen BM, Renshaw PF. Multinuclear magnetic resonance spectroscopy of high-energy phosphate metabolites in human brain following oral supplementation of creatine-monohydrate. Psychiatry Res. 2003 Jun 30;123(2):87-100. doi: 10.1016/s0925-4927(03)00046-5.

    PMID: 12850248BACKGROUND

  • Poortmans JR, Francaux M. Adverse effects of creatine supplementation: fact or fiction? Sports Med. 2000 Sep;30(3):155-70. doi: 10.2165/00007256-200030030-00002.

    PMID: 10999421BACKGROUND

  • Bizzarini E, De Angelis L. Is the use of oral creatine supplementation safe? J Sports Med Phys Fitness. 2004 Dec;44(4):411-6.

    PMID: 15758854BACKGROUND

  • Edmunds JW, Jayapalan S, DiMarco NM, Saboorian MH, Aukema HM. Creatine supplementation increases renal disease progression in Han:SPRD-cy rats. Am J Kidney Dis. 2001 Jan;37(1):73-78. doi: 10.1053/ajkd.2001.20590.

    PMID: 11136170BACKGROUND

  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PMID: 11556941BACKGROUND

  • Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

    PMID: 17695343BACKGROUND

  • Gadermann AM, Engel CC, Naifeh JA, Nock MK, Petukhova M, Santiago PN, Wu B, Zaslavsky AM, Kessler RC. Prevalence of DSM-IV major depression among U.S. military personnel: meta-analysis and simulation. Mil Med. 2012 Aug;177(8 Suppl):47-59. doi: 10.7205/milmed-d-12-00103.

    PMID: 22953441BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

Creatinemaltodextrin

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Lee Church, MD

    Mike O'Callaghan Military Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Subjects will be randomized using a random number generator to receive either creatine monohydrate or a placebo for 90 days. Both subjects and investigators will be blinded to the study group assignments
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2018

First Posted

February 14, 2018

Study Start

January 1, 2019

Primary Completion

January 7, 2019

Study Completion

January 7, 2019

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)