NCT01089075

Neuropsychological Effects of Hydrocortisone in Patients With Partial Adrenal Insufficiency

Phase IV Study to Evaluate the Neuropsychological Effects of Hydrocortisone Substitution in Patients With Partial Adrenal Insufficiency After Traumatic Brain Injury or Subarachnoidal Haemorrhage

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Max-Planck-Institute of Psychiatry · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of hydrocortisone replacement therapy in patients with partial cortisol deficiency after traumatic brain injury or subarachnoid hemorrhage on cognitive function.

Detailed description

This is a controlled, randomized, double-blind, placebo-controlled, crossover, interventional study. The benefit of replacement in partial corticotropic failure on brain function (cognition), especially in cases with borderline low cortisol levels after stimulation is unknown. Moreover, since glucocorticoids might affect hGH secretion, the effect of hydrocortisone on hGH secretion reflected by IGF-1 levels will be assessed. If IGF-1 is below 2 SD at the end of the study, hGH secretion will additionally be determined by a GHRH-arginine-test. An improved cognition in TBI and SAH patients with partial corticotropic insufficiency would give a new treatment option in this population which may lead to better quality of life and an enhanced rehabilitation process.

Conditions

• Partial Corticotrope Insufficiency

Interventions

Type	Name	Description
DRUG	Hydrocortisone	20 mg po for 7 days (2 tablets)
DRUG	Placebo	2 tablets po

Timeline

• Start date: 2010-02-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2010-03-18
• Last updated: 2015-04-08

Locations

1 site across 1 country: Germany