Depression
Conditions
Keywords
depression
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.
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.
Interventions
DRUGCreatine monohydrate
Subjects will take by mouth 5 grams a day of creatine monohydrate powder.
DRUGPlacebo
Subjects will take by mouth 5 grams a day of placebo powder.
Sponsors
Mike O'Callaghan Military Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
PATIENTS MUST BE ABLE TO GET CARE AT NELLIS AIR FORCE BASE (A MILITARY INSTALLATION) IN ORDER TO PARTICIPATE IN THIS STUDY Inclusion Criteria: * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-9 (PHQ-9) | 5 repeated measurements over the 120-day course of the study | Questionnaire |
| Generalized Anxiety Disorder 7 (GAD-7) | 5 repeated measurements over the 120-day course of the study | Questionnaire |
Countries
United States
Outcome results
None listed