Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01089075
Other study ID # 2009-014909-14
Secondary ID
Status Terminated
Phase Phase 4
First received February 2, 2010
Last updated April 7, 2015
Start date February 2010
Est. completion date March 2015

Study information

Verified date April 2015
Source Max-Planck-Institute of Psychiatry
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 32
Est. completion date March 2015
Est. primary completion date March 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Hydrocortisone
20 mg po for 7 days (2 tablets)
Placebo
2 tablets po

Locations

Country Name City State
Germany Schön Klinik Bad Aibling Bad Aibling Bavaria

Sponsors (2)

Lead Sponsor Collaborator
Max-Planck-Institute of Psychiatry Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in score of alertness test (TAP)- interindividual differences 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) No
Secondary Changes in score of Alertness Test (TAP) - intraindividual differences 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) No