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

Hypopituitarism Clinical Trial

Official title:

Effects of CRH on the Sleep in Patients With Hypopituitarism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00666068
• Other study ID #: L2/2003A
• 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

• Hypopituitarism

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