Overview

Neuropsychological Effects of Hydrocortisone in Patients With Partial Adrenal Insufficiency

Status:
Terminated
Trial end date:
2015-03-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Max-Planck-Institute of Psychiatry
Collaborator:
Novo Nordisk A/S
Treatments:
Cortisol succinate
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Criteria
Inclusion Criteria:

- Adult patients (male and female) between 18 and 75 years

- 1 -12 month after TBI or SAH before prescreening

- Cortisol level 100-180 ng/ml after stimulation with ACTH

- Written informed consent by patient or a legally accepted representative

Exclusion Criteria:

- Pregnancy and lactation period (during study treatment)

- Concomitant or previous high-dose therapy with glucocorticoids; previous treatment
with glucocorticoids will be accepted, if it has been low dose (i.e. lower than the
Cushing threshold) and has been stopped at least 3 months before study participation

- Suspected or known hypersensitivity to hydrocortisone or any of its components

- Albumine less than 2,5 g/dl

- Suspected or known drug or alcohol abuse

- Planned treatment for thyroid dysfunction or a planned change in established thyroid
treatment

- Any condition which in the opinion of the investigator makes the patient unsuitable
for inclusion.

- Participation in another clinical trial with investigational new drugs

- Severe medical or psychiatric disease

- Change of dosage of any other drug which might influence the corticotrope axis or
cognitive function (e.g. antidepressive treatment) during the last 3 weeks

- Oral contraceptives

- Severe disturbances in articulation, visual faculty or hearing

- Any elective surgery or medical treatment planned in the observation period

- Intensive Care treatment