Clinical trial NCT03433651: Creatine Monohydrate Use for Preventing Altitude Induced Depression
Official title: Creatine Monohydrate Use for Preventing Altitude Induced Depression
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Depression
Keywords: depression
Lead sponsor: Mike O'Callaghan Military Hospital
Sponsor class: FED
First posted: 2018-02-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 5 repeated measurements over the 120-day course of the study
measure: Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: 5 repeated measurements over the 120-day course of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Mike O'Callaghan Military Medical Center
state: Nevada
Study officials:
affiliation: Mike O'Callaghan Military Medical Center
name: Lee Church, MD
role: PRINCIPAL_INVESTIGATOR
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