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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Recruitment Status : Withdrawn (Unable to locate grant funding.)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

Tracking Information
First Submitted Date  ICMJE February 8, 2018
First Posted Date  ICMJE February 14, 2018
Last Update Posted Date January 9, 2019
Actual Study Start Date  ICMJE January 1, 2019
Actual Primary Completion Date January 7, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2018)
  • Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: 5 repeated measurements over the 120-day course of the study ]
    Questionnaire
  • Generalized Anxiety Disorder 7 (GAD-7) [ Time Frame: 5 repeated measurements over the 120-day course of the study ]
    Questionnaire
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03433651 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Creatine Monohydrate Use for Preventing Altitude Induced Depression
Official Title  ICMJE Creatine Monohydrate Use for Preventing Altitude Induced Depression
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE 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
Condition  ICMJE Depression
Intervention  ICMJE
  • Drug: Creatine monohydrate
    Subjects will take by mouth 5 grams a day of creatine monohydrate powder.
    Other Name: creapure
  • Drug: Placebo
    Subjects will take by mouth 5 grams a day of placebo powder.
    Other Name: maltodextrin
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Creatine monohydrate
  • 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.
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: January 7, 2019)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 8, 2018)
75
Actual Study Completion Date  ICMJE January 7, 2019
Actual Primary Completion Date January 7, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03433651
Other Study ID Numbers  ICMJE FWH20180039H
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mike O'Callaghan Military Hospital
Study Sponsor  ICMJE Mike O'Callaghan Military Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lee Church, MD Mike O'Callaghan Military Medical Center
PRS Account Mike O'Callaghan Military Hospital
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP