Effects of Ghrelin on the Sleep-EEG and Nocturnal Secretion of Hormones
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Purpose
Ghrelin, an acylated peptide consisting of 28 amino acids, is the endogenous ligand of the growth hormone secretagogue receptor (GHS-R). It is synthesized predominantly in the stomach but has been also identified in a variety of other organs. Alike, a wide range of central and peripheral endocrine and non-endocrine actions has been described, e. g. being a releasing factor of growth hormone, prolactin and ACTH, a modulator of cell proliferation and apoptosis, a regulator of sleep-wake regulation, and a orexigenic hormone. Aims of this study are:
A) To determine the effect of exogenous ghrelin on sleep-EEG variables and hormones of the hypothalamic-pituitary-adrenocortical (HPA) axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis in healthy subjects of both genders (age groups: 20-30, 35-45, 60-70 years).
B) To determine the effect of exogenous ghrelin on sleep-EEG variables and hormones of the HPA axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis in patients with major depression (age range: 20-65 years).
| Condition | Intervention |
|---|---|
|
Healthy Major Depression |
Drug: ghrelin |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject) Primary Purpose: Basic Science |
| Official Title: | Effects of Ghrelin on the Sleep-EEG and Nocturnal Secretion of Hormones |
- sleep, conventionally and quantitatively analyzed [ Time Frame: study duration ]
- hormones of the hypothalamic-pituitary-adrenocortical (HPA) axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis [ Time Frame: study duration ]
| Estimated Enrollment: | 80 |
| Study Start Date: | March 2004 |
| Study Completion Date: | October 2007 |
-
Drug: ghrelin
Eligibility| Ages Eligible for Study: | 20 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy females and males
- Male and female patients with major depression
Exclusion Criteria:
- Life time or family history of psychiatric or neurological disorders
- Sleep disturbances
- Shift work
- Any current disease
- Any medication
- Long distance flight within 3 months prior to study entry
- Smoking
- Any medication during the week prior to study entry
- Any current disease other than major depression
Contacts and Locations| Germany | |
| Max Planck Institute of Psychiatry | |
| Munich, Germany, 80804 | |
| Principal Investigator: | Professor Axel Steiger, MD | Max-Planck-Institute of Psychiatry |
More Information
No publications provided by Max-Planck-Institute of Psychiatry
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00447512 History of Changes |
| Other Study ID Numbers: | L2/2003 |
| Study First Received: | March 13, 2007 |
| Last Updated: | October 29, 2007 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major Behavioral Symptoms Mood Disorders |
Mental Disorders Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013