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| Sponsored by: |
Max-Planck-Institute of Psychiatry |
|---|---|
| Information provided by: | Max-Planck-Institute of Psychiatry |
| ClinicalTrials.gov Identifier: | NCT00666068 |
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: | Basic Science, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Pharmacodynamics Study |
| Official Title: | Effects of CRH on the Sleep in Patients With Hypopituitarism |
| Estimated Enrollment: | 30 |
| Study Start Date: | February 2008 |
| Estimated Study Completion Date: | December 2008 |
| Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
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
|
|
2: Placebo Comparator
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 |
Patients with hypopituitarism
Inclusion Criteria:
Exclusion Criteria:
Healthy controls
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Axel Steiger, MD | +49 8930622 ext 236 | steiger@mpipsykl.de |
| Contact: Michael Kluge, MD | +49 8930622 ext 396 | kluge@mpipsykl.de |
| Germany | |
| Max Planck Institute of Psychiatry | Recruiting |
| Munich, Germany, 80804 | |
| Contact: Michael Kluge, MD +49 89 30622 ext 396 kluge@mpipsykl.de | |
| Sub-Investigator: Michael Kluge, MD | |
More Information
| Responsible Party: | Max-Planck-Institute of Psychiatry ( Prof. Dr. Axel Steiger ) |
| Study ID Numbers: | L2/2003A |
| Study First Received: | April 22, 2008 |
| Last Updated: | April 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00666068 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Patients with hypopituitarism |
|
Hypothalamic Diseases Corticotropin-Releasing Hormone Pituitary Diseases Hypopituitarism Endocrine System Diseases |
Central Nervous System Diseases Endocrinopathy Brain Diseases Adrenocorticotropic Hormone |
|
Physiological Effects of Drugs Nervous System Diseases Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Pharmacologic Actions |
