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

Max-Planck-Institut für Psychiatrie0 个研究点目标入组 32 人开始时间: 2010年1月4日最近更新: 2015年7月10日

适应症

试验速览

暂无简介。

•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

•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

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