Neuropsychological Effects of Hydrocortisone in Patients With Partial Adrenal Insufficiency

Partial Corticotrope Insufficiency Clinical Trial

— CSMünchen01  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01089075
• Other study ID #: 2009-014909-14
• 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

• Adrenal Insufficiency
• Partial Corticotrope Insufficiency

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

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