DepressionPhase 4NCT03433651
Creatine Monohydrate Use for Preventing Altitude Induced Depression
A Phase 4 study testing Creatine monohydrate in people with Depression, run by Mike O'Callaghan Military Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depression
- What is being tested?
- Creatine monohydrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2019to 7 Jan 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mike O'Callaghan Military Medical Center
Las Vegas, Nevada, 89191
About this study
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.
Read the detailed description
Subjects will be in this research study if they moved to Creech AFB from an elevation of less than 2.000 feet within the last month. The purpose of this study is to see if creatine monohydrate is effective in preventing altitude-induced depression. This study will enroll approximately 75 subjects.
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.
Creatine Monohydrate is a dietary supplement that is believed to aid in the building of muscle mass.
The placebo being used in this study is Maltodextrin (a sugar). Maltodextrin is an FDA approved food additive made from a highly processed starch product typically made from corn.
- Conditions
- Depression
- Being tested
- Creatine monohydrate, Placebo
- Keywords
- depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Creatine monohydrateDrug
Also called creapure
Subjects will take by mouth 5 grams a day of creatine monohydrate powder.
PlaceboDrug
Also called maltodextrin
Subjects will take by mouth 5 grams a day of placebo powder.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire-9 (PHQ-9)
Questionnaire
Measured: 5 repeated measurements over the 120-day course of the study
Generalized Anxiety Disorder 7 (GAD-7)
Questionnaire
Measured: 5 repeated measurements over the 120-day course of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start1 Jan 2019
- Primary completion7 Jan 2019
- Study completion7 Jan 2019
Why it stopped: Unable to locate grant funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mike O'Callaghan Military Hospital
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lee Church, MD, Principal investigator, Mike O'Callaghan Military Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433651
- Sponsor's protocol ID
- FWH20180039H
- Status last verified
- Sep 2024
- First submitted
- 8 Feb 2018
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15939839DelMastro 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.
PubMed 21074272Bardwell 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.
PubMed 15677302Lyoo 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.
PubMed 22864465Armed 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.
PubMed 25923401Brenner 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.
PubMed 21214344Kim 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.
PubMed 20843869Drevets 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.
PubMed 10415674Rango 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.
PubMed 9402187Shi 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.
PubMed 24768210Lyoo 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.
PubMed 12850248Poortmans 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.
PubMed 10999421Bizzarini E, De Angelis L. Is the use of oral creatine supplementation safe? J Sports Med Phys Fitness. 2004 Dec;44(4):411-6.
PubMed 15758854Edmunds 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.
PubMed 11136170Kroenke 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.
PubMed 11556941
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creatine Monohydrate Use for Preventing Altitude Induced Depression
- ClinicalTrials.gov ID
- NCT03433651
- Acronym / sponsor ID
- FWH20180039H
- Conditions
- Depression
- Keywords
- depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to locate grant funding.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mike O'Callaghan Military HospitalUS federal agency
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 7 Jan 2019 (actual)
- Study completion
- 7 Jan 2019 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Subjects will be in this research study if they moved to Creech AFB from an elevation of less than 2.000 feet within the last month. The purpose of this study is to see if creatine monohydrate is effective in preventing altitude-induced depression. This study will enroll approximately 75 subjects.
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.
Creatine Monohydrate is a dietary supplement that is believed to aid in the building of muscle mass.
The placebo being used in this study is Maltodextrin (a sugar). Maltodextrin is an FDA approved food additive made from a highly processed starch product typically made from corn.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| creatine monohydrate | Experimental | Drug: Creatine monohydrateExperimental 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. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Creatine monohydrateAlso: creapureSubjects will take by mouth 5 grams a day of creatine monohydrate powder. | Drug | creatine monohydrate |
| PlaceboAlso: maltodextrinSubjects will take by mouth 5 grams a day of placebo powder. | Drug | Placebo |
Primary outcome
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 5 repeated measurements over the 120-day course of the study
Questionnaire
Generalized Anxiety Disorder 7 (GAD-7)
Time frame: 5 repeated measurements over the 120-day course of the study
Questionnaire
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 15939839Kessler 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.
- Background: PubMed 21074272DelMastro 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.
- Background: PubMed 15677302Bardwell 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.
- Background: PubMed 22864465Lyoo 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.
- Background: PubMed 25923401Armed 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.
- Background: PubMed 21214344Brenner 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.
- Background: PubMed 20843869Kim 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.
- Background: PubMed 10415674Drevets 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.
- Background: PubMed 9402187Rango 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.
- Background: PubMed 24768210Shi 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.
- Background: PubMed 12850248Lyoo 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.
- Background: PubMed 10999421Poortmans 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.
- Individual participant dataSharing planned: No
Related trials for Depression
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Not yet recruiting
Adapting the ESTEEM Intervention to Improve Mental Health and PrEP Uptake Among Men at Risk of HIV
PrEP Use
Recruiting
Cancer Pain Management Using a Web-based Intervention
Cancer of Breast, Depressive Symptoms
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lee Church, MD principal investigator
Mike O'Callaghan Military Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Creatine monohydrate in people with Depression, run by Mike O'Callaghan Military Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire-9 (PHQ-9) (time frame: 5 repeated measurements over the 120-day course of the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03433651, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.