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

Primary Purpose

Partial Corticotrope Insufficiency

Status
Terminated
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Hydrocortisone
Placebo
Sponsored by
Max-Planck-Institute of Psychiatry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partial Corticotrope Insufficiency focused on measuring neuropsychological effects of hydrocortisone replacement

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Schön Klinik Bad Aibling

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

placebo/20 mg hydrocortisone

20 mg hydrocortisone/placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in score of alertness test (TAP)- interindividual differences

Secondary Outcome Measures

Changes in score of Alertness Test (TAP) - intraindividual differences

Full Information

First Posted
February 2, 2010
Last Updated
April 7, 2015
Sponsor
Max-Planck-Institute of Psychiatry
Collaborators
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01089075
Brief Title
Neuropsychological Effects of Hydrocortisone in Patients With Partial Adrenal Insufficiency
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
Insufficient recruitment of suitable patients.
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Max-Planck-Institute of Psychiatry
Collaborators
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partial Corticotrope Insufficiency
Keywords
neuropsychological effects of hydrocortisone replacement

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
placebo/20 mg hydrocortisone
Arm Type
Placebo Comparator
Arm Description
Order of study treatment: 7 days placebo followed by 7 days 20 mg hydrocortisone
Arm Title
20 mg hydrocortisone/placebo
Arm Type
Active Comparator
Arm Description
Order of study treatment: 7 days 20 mg hydrocortisone followed by 7 days placebo
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone
Other Intervention Name(s)
Hydrocortison GALEN 20 mg
Intervention Description
20 mg po for 7 days (2 tablets)
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
P-Tabletten 7 mm Lichtenstein
Intervention Description
2 tablets po
Primary Outcome Measure Information:
Title
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)
Secondary Outcome Measure Information:
Title
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Günter K. Stalla, Prof. Dr.
Organizational Affiliation
Max-Planck-Institute, Munich
Official's Role
Study Director
Facility Information:
Facility Name
Schön Klinik Bad Aibling
City
Bad Aibling
State/Province
Bavaria
ZIP/Postal Code
83043
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.endokrinologie.net/dge.php
Description
Click here for more information about endocrinological diseases

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Neuropsychological Effects of Hydrocortisone in Patients With Partial Adrenal Insufficiency

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