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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00666068
First Posted: April 24, 2008
Last Update Posted: May 12, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Max-Planck-Institute of Psychiatry
  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
Intervention Model: Crossover Assignment
Masking: Single (Participant)
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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00666068


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

Responsible Party: Prof. Dr. Axel Steiger, Max-Planck-Institute of Psychiatry
ClinicalTrials.gov Identifier: NCT00666068     History of Changes
Other Study ID Numbers: L2/2003A
First Submitted: April 22, 2008
First Posted: April 24, 2008
Last Update Posted: May 12, 2011
Last Verified: May 2011

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

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