About this trial
The purpose of this study is to determine whether growth hormone replacement therapy (GHRT) is effective versus placebo in the improvement of Quality of Life in patients with adult growth hormone deficiency (AGHD) and mild traumatic brain injury (mTBI).
Eligibility criteria
Qualifiers
OEF/OIF/OND Veteran
Score of 18 or more on Combat Experiences sub-scale of Deployment Risk and Resilience Inventory-2 (DRRI-2)
Age 21 - 55 years old
One or more mTBI sustained during military service at least 12 months prior to the screening date, as noted via the CRAFT survey.
Disqualifiers
History of moderate or severe TBI
History of neurologic disorder other than TBI with substantial impact on quality of life
History of bipolar disorder, schizophrenia, or other concurrent psychotic disorder
Active suicidal ideation (no plan required) as determined by a score of 2 points or more on the Columbia Suicide Severity Rating Scale (C-SSRS) suicidal ideation rating, or overt suicidal behavior in the past 6 months.
Trial design
Treatments tested in this trial
- Somatropin
- Placebo