Creatine Monohydrate Use for Preventing Altitude Induced Depression

• Status: Withdrawn
• Trial end date: 2019-01-07
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mike O'Callaghan Military Hospital

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