Clinical Trial: Neuropsychological Effects of Hydrocortisone in Patients With Partial Adrenal Insufficiency

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief 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 Summary:

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.

Sponsor: Max-Planck-Institute of Psychiatry

Current Primary Outcome: Changes in score of alertness test (TAP)- interindividual differences [ Time Frame: day -5 to - 0 (before start of study treatment), day 7 (after 7 days treatment with Hydrocortisone or Placebo, day 14 (after 7 days treatment with Hydrocortisone or Placebo) ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Changes in score of Alertness Test (TAP) - intraindividual differences [ Time Frame: day -5 to - 0 (before start of study treatment), day 7 (after 7 days treatment with Hydrocortisone or Placebo, day 14 (after 7 days treatment with Hydrocortisone or Placebo) ]

Original Secondary Outcome: Same as current

Information By: Max-Planck-Institute of Psychiatry

Dates:
Date Received: February 2, 2010
Date Started: February 2010
Date Completion:
Last Updated: April 7, 2015
Last Verified: April 2015