Creatine Monohydrate Use for Preventing Altitude Induced Depression

Study Overview
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Brief Summary
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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
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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.

Official Title
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Creatine Monohydrate Use for Preventing Altitude Induced Depression

Conditions
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Depression

Intervention / Treatment
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* Drug: Creatine monohydrate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: creatine monohydrate<br>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<br>* Subjects will take by mouth 5 grams a day of creatine monohydrate powder.<br>* Other names: creapure;|
| Placebo Comparator: Placebo<br>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<br>* Subjects will take by mouth 5 grams a day of placebo powder.<br>* Other names: maltodextrin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression