Neuropsychological Effects of Hydrocortisone in Patients With Partial Adrenal Insufficiency (CSMünchen01)

Max-Planck-Institute of Psychiatry

Status and phase: Terminated; Phase 4

Conditions: Partial Corticotrope Insufficiency

Treatments: Drug: Placebo; Drug: Hydrocortisone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01089075

2009-014909-14

Details and patient eligibility

About

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.

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

---

32 participants in 2 patient groups, including a placebo group

placebo/20 mg hydrocortisone

Placebo Comparator group

Description:

Order of study treatment: 7 days placebo followed by 7 days 20 mg hydrocortisone

Treatment:

Drug: Hydrocortisone

Drug: Placebo

20 mg hydrocortisone/placebo

Active Comparator group

Description:

Order of study treatment: 7 days 20 mg hydrocortisone followed by 7 days placebo

Treatment:

Drug: Hydrocortisone

Drug: Placebo