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CompletedNCT00666068Updated May 12, 2011

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

An interventional study of corticotropin releasing hormone (CRH) and Placebo in Hypopituitarism, sponsored by Max-Planck-Institute of Psychiatry. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-05-12.

Sponsored by Max-Planck-Institute of Psychiatry · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hypopituitarism

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Keywords

  • Patients with hypopituitarism
03

In context

Hypopituitarism

47 studies on the registry are indexed under Hypopituitarism; 8 are open to participants now.

This study's planned enrollment of 30 is below the median of 38 across 29 interventional studies indexed under Hypopituitarism.

Browse Hypopituitarism studies →

Lead sponsor

Max-Planck-Institute of Psychiatry is the lead sponsor of 19 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    1

    Patients with hypopituitarism Cross over design: see interventions 1-2

    Other: corticotropin releasing hormone (CRH) · Other: Placebo

  • Placebo comparator
    2

    Parallel design: Healthy controls to be compared with placebo condition in patients with hypopituitarism

    Other: Placebo

Interventions

  • Othercorticotropin releasing hormone (CRH)

    50 µg injected at 2200, 2300, 0000, and 0100

  • OtherPlacebo

    injected at 2200, 2300, 0000, and 0100

  • OtherPlacebo

    injected at 2200, 2300, 0000, and 0100

06

What researchers measure

Primary outcomes

  1. Sleep-EEG variables, conventionally and quantitatively analyzed

    Time frame: within the first month

07

Study locations

1 site
  • Max Planck Institute of Psychiatry
    Munich, 80804, Germany
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2008, a primary completion of Oct 2008 and a completion of Dec 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 22, 2008
First posted
Apr 24, 2008
Start
Feb 2008
Primary completionActual
Oct 2008
CompletionActual
Dec 2008
Last update
May 12, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 12, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00666068
Lead sponsor
Max-Planck-Institute of Psychiatry
First posted
Apr 24, 2008
Start date
Feb 2008
Primary completion
Oct 2008
Completion
Dec 2008
Last update
May 12, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.

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