europsychological effects of hydrocortisone substitution in patients with partial adrenal insufficiency after traumatic brain injury or subarachnoidal haemorrhage - HC-study

• Conditions: hormonal deficiency after traumatic-brain- injury (TBI) or subarachnoidal haemorrhage (SAH); MedDRA version: 12.1Level: LLTClassification code 10011198Term: Cortisol decreased

• Registration Number: EUCTR2009-014909-14-DE
• Lead Sponsor: Max-Planck-Institut für Psychiatrie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-04
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

1)Adult patients (male and female) between 18 and 75 years
2)1 -12 month after TBI or SAH before prescreening
3)Cortisol level 100-180 ng/ml after stimulation with ACTH (250 microgramm according to ACTH low-dose short test)
4)Written informed consent by patient or a legally accepted representative

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Pregnancy and lactation period (during study treatment)
2.Concomitant or previous high-dose therapy with glucocorticoides; previous treatment with glucocorticoides will be accepted, if it has been low dose (i.e. lower than the Cushing threshold) and has been stopped at least 3 month before study participation.
3.Suspected or known hypersensitivity to hydrocortisone or any of its components
4.Albumine = 2,5 g/dl
5.Suspected or known drug or alcohol abuse
6.Planned treatment for thyroid dysfunction or a planned
change in established thyroid treatment
7.Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion.
8.Participation in another clinical trial with investigational new drugs
9.Severe medical or psychiatric disease
10.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
11.Oral contraceptives
12.Severe disturbances in articulation, visual faculty or hearing
13.Any elective surgery or medical treatment planned in the observation period
14.Intensive Care treatment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Changes (?) in score of Alertness test (TAP);Main Objective: To evaluate the interindividual difference (?) of cognitive function in patients with or without hydrocortisone treatment after 7 and 14 days of treatment ;Secondary Objective: To evaluate the intraindividual difference (?) of cognitive function in patients with or without hydrocortisone treatment after 7 and 14 days of treatment