Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age21-55
SponsorVA Office of Research and Development

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

Treatment groups

172 Participants
are divided into 2 treatment groups