Creatine Monohydrate Use for Preventing Altitude Induced Depression
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|ClinicalTrials.gov Identifier: NCT03433651|
Recruitment Status : Withdrawn (Unable to locate grant funding.)
First Posted : February 14, 2018
Last Update Posted : January 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Depression||Drug: Creatine monohydrate Drug: Placebo||Phase 4|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, 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|
|Official Title:||Creatine Monohydrate Use for Preventing Altitude Induced Depression|
|Actual Study Start Date :||January 1, 2019|
|Actual Primary Completion Date :||January 7, 2019|
|Actual Study Completion Date :||January 7, 2019|
Experimental: creatine monohydrate
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
Subjects will take by mouth 5 grams a day of creatine monohydrate powder.
Other Name: creapure
Placebo Comparator: Placebo
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.
Subjects will take by mouth 5 grams a day of placebo powder.
Other Name: maltodextrin
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03433651
|United States, Nevada|
|Mike O'Callaghan Military Medical Center|
|Las Vegas, Nevada, United States, 89191|
|Principal Investigator:||Lee Church, MD||Mike O'Callaghan Military Medical Center|