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
  Purpose

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.


Condition Intervention
Hypopituitarism
Other: corticotropin releasing hormone (CRH)
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Effects of CRH on the Sleep in Patients With Hypopituitarism

Resource links provided by NLM:


Further study details as provided by Max-Planck-Institute of Psychiatry:

Primary Outcome Measures:
  • Sleep-EEG variables, conventionally and quantitatively analyzed [ Time Frame: within the first month ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: February 2008
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

Patients with hypopituitarism

Cross over design: see interventions 1-2

Other: corticotropin releasing hormone (CRH)
50 µg injected at 2200, 2300, 0000, and 0100
Other: Placebo
injected at 2200, 2300, 0000, and 0100
Placebo Comparator: 2

Parallel design:

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

Other: Placebo
injected at 2200, 2300, 0000, and 0100

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00666068

Locations
Germany
Max Planck Institute of Psychiatry
Munich, Germany, 80804
Sponsors and Collaborators
Max-Planck-Institute of Psychiatry
  More Information

No publications provided

Responsible Party: Prof. Dr. Axel Steiger, Max-Planck-Institute of Psychiatry
ClinicalTrials.gov Identifier: NCT00666068     History of Changes
Other Study ID Numbers: L2/2003A
Study First Received: April 22, 2008
Last Updated: May 11, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Max-Planck-Institute of Psychiatry:
Patients with hypopituitarism

Additional relevant MeSH terms:
Hypopituitarism
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases
Hypothalamic Diseases
Nervous System Diseases
Pituitary Diseases
Adrenocorticotropic Hormone
Corticotropin-Releasing Hormone
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014