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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00666068
Other study ID # L2/2003A
Secondary ID
Status Completed
Phase N/A
First received April 22, 2008
Last updated May 11, 2011
Start date February 2008
Est. completion date December 2008

Study information

Verified date May 2011
Source Max-Planck-Institute of Psychiatry
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

In contrast to healthy subjects, patients with hypopituitarism do not exhibit endocrine responses when hormones are injected. This is at least true for those with a complete insufficiency of the anterior pituitary. For example, administration of corticotropin releasing hormone (CRH) is not followed by an increase of ACTH and cortisol. Therefore, "pure" hormone effects can be investigated.

It is well established that hormones of the hypothalamic-pituitary-adrenal axis are involved in sleep regulation. In rodents, CRH decreased slow wave sleep (SWS). In humans, CRH was reported to increase wakefulness and to decrease SWS and REM sleep. Primary objective was therefore to study the effect of CRH on patients with hypopituitarism.

To date, there is no information on sleep of patients with hypopituitarism. Secondary objective is therefore to compare sleep of patients with hypopituitarism with sleep of age-matched healthy controls.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 2008
Est. primary completion date October 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 75 Years
Eligibility Patients with hypopituitarism

Inclusion Criteria:

- Age 18-75 years

- Complete insufficiency of the anterior pituitary

- Stable hormone substitution for at least 3 months

Exclusion Criteria:

- Hormone excess in the past

- Sleep disorder, e.g. sleep apnea syndrome

Healthy controls

Inclusion Criteria:

- Age 18-75 years

Exclusion Criteria:

- Any medication during 6 week prior to study entry

- Shift work

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Other:
corticotropin releasing hormone (CRH)
50 µg injected at 2200, 2300, 0000, and 0100
Placebo
injected at 2200, 2300, 0000, and 0100
Placebo
injected at 2200, 2300, 0000, and 0100

Locations

Country Name City State
Germany Max Planck Institute of Psychiatry Munich

Sponsors (1)

Lead Sponsor Collaborator
Max-Planck-Institute of Psychiatry

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sleep-EEG variables, conventionally and quantitatively analyzed within the first month No
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