Effects of Corticotropin Releasing Hormone (CRH) on the Sleep in Patients With Hypopituitarism

This study has been completed.
Sponsor:
Information provided by:
Max-Planck-Institute of Psychiatry
ClinicalTrials.gov Identifier:
NCT00666068
First received: April 22, 2008
Last updated: May 11, 2011
Last verified: May 2011

April 22, 2008
May 11, 2011
February 2008
October 2008   (final data collection date for primary outcome measure)
Sleep-EEG variables, conventionally and quantitatively analyzed [ Time Frame: within the first month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00666068 on ClinicalTrials.gov Archive Site
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Effects of Corticotropin Releasing Hormone (CRH) on the Sleep in Patients With Hypopituitarism
Effects of CRH on the Sleep in Patients With Hypopituitarism

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Hypopituitarism
  • Other: corticotropin releasing hormone (CRH)
    50 µg injected at 2200, 2300, 0000, and 0100
  • Other: Placebo
    injected at 2200, 2300, 0000, and 0100
  • Experimental: 1

    Patients with hypopituitarism

    Cross over design: see interventions 1-2

    Interventions:
    • Other: corticotropin releasing hormone (CRH)
    • Other: Placebo
  • Placebo Comparator: 2

    Parallel design:

    Healthy controls to be compared with placebo condition in patients with hypopituitarism

    Intervention: Other: Placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00666068
L2/2003A
No
Prof. Dr. Axel Steiger, Max-Planck-Institute of Psychiatry
Max-Planck-Institute of Psychiatry
Not Provided
Not Provided
Max-Planck-Institute of Psychiatry
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP