Creatine Monohydrate Use for Preventing Altitude Induced Depression

January 7, 2019 updated by: Mike O'Callaghan Military Hospital
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89191
        • Mike O'Callaghan Military Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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.
Drug: Placebo
Subjects will take by mouth 5 grams a day of placebo powder.
Other Names:
  • maltodextrin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: 5 repeated measurements over the 120-day course of the study
Questionnaire
5 repeated measurements over the 120-day course of the study
Generalized Anxiety Disorder 7 (GAD-7)
Time Frame: 5 repeated measurements over the 120-day course of the study
Questionnaire
5 repeated measurements over the 120-day course of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mike O'Callaghan Military Hospital

Investigators

  • Principal Investigator: Lee Church, MD, Mike O'Callaghan Military Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Actual)

January 7, 2019

Study Completion (Actual)

January 7, 2019

Study Registration Dates

First Submitted

February 8, 2018

First Submitted That Met QC Criteria

February 8, 2018

First Posted (Actual)

February 14, 2018

Study Record Updates

Last Update Posted (Actual)

January 9, 2019

Last Update Submitted That Met QC Criteria

January 7, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FWH20180039H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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