Partial Corticotrope Insufficiency Clinical Trial
— CSMünchen01Official 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
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | Schön Klinik Bad Aibling | Bad Aibling | Bavaria |
Lead Sponsor | Collaborator |
---|---|
Max-Planck-Institute of Psychiatry | Novo Nordisk A/S |
Germany,
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 |