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

April 7, 2015 updated by: Max-Planck-Institute of Psychiatry

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Bad Aibling, Bavaria, Germany, 83043
        • Schön Klinik Bad Aibling

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo/20 mg hydrocortisone
Order of study treatment: 7 days placebo followed by 7 days 20 mg hydrocortisone
Drug: Hydrocortisone
20 mg po for 7 days (2 tablets)
Other Names:
  • Hydrocortison GALEN 20 mg
Drug: Placebo
2 tablets po
Other Names:
  • P-Tabletten 7 mm Lichtenstein
Active Comparator: 20 mg hydrocortisone/placebo
Order of study treatment: 7 days 20 mg hydrocortisone followed by 7 days placebo
Drug: Hydrocortisone
20 mg po for 7 days (2 tablets)
Other Names:
  • Hydrocortison GALEN 20 mg
Drug: Placebo
2 tablets po
Other Names:
  • P-Tabletten 7 mm Lichtenstein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in score of alertness test (TAP)- interindividual differences
Time Frame: 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)
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)

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in score of Alertness Test (TAP) - intraindividual differences
Time Frame: 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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Max-Planck-Institute of Psychiatry

Collaborators

Novo Nordisk A/S

Investigators

  • Study Director: Günter K. Stalla, Prof. Dr., Max-Planck-Institute, Munich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

February 2, 2010

First Submitted That Met QC Criteria

March 17, 2010

First Posted (Estimate)

March 18, 2010

Study Record Updates

Last Update Posted (Estimate)

April 8, 2015

Last Update Submitted That Met QC Criteria

April 7, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-014909-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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