NCT03433651

Creatine Monohydrate Use for Preventing Altitude Induced Depression

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mike O'Callaghan Military Hospital · Federal
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression

Interventions

Type	Name	Description
DRUG	Creatine monohydrate	Subjects will take by mouth 5 grams a day of creatine monohydrate powder.
DRUG	Placebo	Subjects will take by mouth 5 grams a day of placebo powder.

Timeline

• Start date: 2019-01-01
• Primary completion: 2019-01-07
• Completion: 2019-01-07
• First posted: 2018-02-14
• Last updated: 2024-09-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study