Phase
Condition
Neurologic Disorders
Growth Hormone Deficiencies/abnormalities
Brain Injury
Treatment
Placebo
Somatropin
Clinical Study ID
Ages 21-55 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
OEF/OIF/OND Veteran
Score of 18 or more on Combat Experiences sub-scale of Deployment Risk andResilience Inventory-2 (DRRI-2)
Age 21 - 55 years old
One or more mTBI sustained during military service at least 12 months prior to thescreening date, as noted via the CRAFT survey.
GH deficiency diagnosed by: macimorelin stimulation test (cut point 5.1 mcg/L), orglucagon stimulation test (cut point: 3 mcg/L for BMI up to 25; cut point 1 mcg/Lfor BMI 25 and above) and IGF-I lab values have to be less than or equal to +1 SDSat baseline
Score of 11 or more on QoL-AGHDA
4-week stability on any psychotropic medications
3-month stability on all other hormone treatments
Able and willing to provide informed consent to participate in this study, andcomplete study protocol.
Exclusion
Exclusion Criteria:
History of moderate or severe TBI
History of neurologic disorder other than TBI with substantial impact on quality oflife
History of bipolar disorder, schizophrenia, or other concurrent psychotic disorder
Active suicidal ideation (no plan required) as determined by a score of 2 points ormore on the Columbia Suicide Severity Rating Scale (C-SSRS) suicidal ideationrating, or overt suicidal behavior in the past 6 months.
Contraindication to rhGH therapy
Acute medical illness, active infection, cancer or decompensated chronic medicalillness
Evidence of substance use disorder, -other than mild alcohol or cannabis usedisorder-, or urine toxicology evidence of the use of an illicit drug (excludingcannabis), in the past 6 months. Nicotine use is allowed.
Score less than or equal to 41 on Trial 2 or Retention Trial of the Test of Memoryand Malingering (TOMM).
BMI > 40 or body weight > 350 lbs
Pituitary anatomy documented by an MRI using a sella protocol within the last 2years indicating abnormalities consistent with an etiology other than mild-TBI (i.e.; pituitary mass)
Women who are pregnant or of child-bearing potential not on contraception
Current use of the following: growth hormone, estrogen or estrogen-like dietarysupplements, progestin, IGF-I, or chronic glucocorticoid use in supraphysiologicdoses
Currently enrolled in any other interventional study unless prior approval isprovided by the study chairs and the study sponsor (Cooperative Studies Program)
Study Design
Connect with a study center
Birmingham VA Medical Center, Birmingham, AL
Birmingham, Alabama 35233-1927
United StatesSite Not Available
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona 85012
United StatesSite Not Available
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California 94304-1207
United StatesSite Not Available
VA San Diego Healthcare System, San Diego, CA
San Diego, California 92161-0002
United StatesSite Not Available
Rocky Mountain Regional VA Medical Center, Aurora, CO
Aurora, Colorado 80045-7211
United StatesSite Not Available
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia 20422-0001
United StatesSite Not Available
Miami VA Healthcare System, Miami, FL
Miami, Florida 33125
United StatesSite Not Available
Miami VA Healthcare System, Miami, FL
Miami 4164138, Florida 4155751 33125
United StatesSite Not Available
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur, Georgia 30033-4004
United StatesSite Not Available
Atlanta VA Medical and Rehab Center, Decatur, GA
Decatur 4191124, Georgia 4197000 30033-4004
United StatesSite Not Available
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan 48105-2303
United StatesSite Not Available
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota 55417-2309
United StatesActive - Recruiting
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis 5037649, Minnesota 5037779 55417-2309
United StatesSite Not Available
Kansas City VA Medical Center, Kansas City, MO
Kansas City, Missouri 64128-2226
United StatesSite Not Available
Omaha VA Nebraska-Western Iowa Health Care System, Omaha, NE
Omaha, Nebraska 68105-1850
United StatesSite Not Available
Salisbury W.G. (Bill) Hefner VA Medical Center, Salisbury, NC
Salisbury, North Carolina 28144
United StatesSite Not Available
Oklahoma City VA Medical Center, Oklahoma City, OK
Oklahoma City, Oklahoma 73104-5007
United StatesSite Not Available
VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
Dallas, Texas 75216-7167
United StatesSite Not Available
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas 77030-4211
United StatesActive - Recruiting
South Texas Health Care System, San Antonio, TX
San Antonio, Texas 78229-4404
United StatesSite Not Available
Michael E. DeBakey VA Medical Center, Houston, TX
Houston 4699066, Texas 4736286 77030-4211
United StatesSite Not Available
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle, Washington 98108-1532
United StatesActive - Recruiting
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Seattle 5809844, Washington 5815135 98108-1532
United StatesSite Not Available

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