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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Recruitment Status : Withdrawn (Unable to locate grant funding.)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
Sponsor:
Information provided by (Responsible Party):
Mike O'Callaghan Military Hospital

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.

Condition or disease Intervention/treatment Phase
Depression Drug: Creatine monohydrate Drug: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
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
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


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 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.
Drug: Placebo
Subjects will take by mouth 5 grams a day of placebo powder.
Other Name: maltodextrin




Primary Outcome Measures :
  1. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 5 repeated measurements over the 120-day course of the study ]
    Questionnaire

  2. Generalized Anxiety Disorder 7 (GAD-7) [ Time Frame: 5 repeated measurements over the 120-day course of the study ]
    Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, Nevada
Mike O'Callaghan Military Medical Center
Las Vegas, Nevada, United States, 89191
Sponsors and Collaborators
Mike O'Callaghan Military Hospital
Investigators
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Principal Investigator: Lee Church, MD Mike O'Callaghan Military Medical Center

Publications:

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Responsible Party: Mike O'Callaghan Military Hospital
ClinicalTrials.gov Identifier: NCT03433651     History of Changes
Other Study ID Numbers: FWH20180039H
First Posted: February 14, 2018    Key Record Dates
Last Update Posted: January 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mike O'Callaghan Military Hospital:
depression
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders