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Effects of Ghrelin on the Sleep-EEG and Nocturnal Secretion of Hormones
This study has been completed.
Sponsors and Collaborators: Max-Planck-Institute of Psychiatry
German Research Foundation
Information provided by: Max-Planck-Institute of Psychiatry
ClinicalTrials.gov Identifier: NCT00447512
  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

MedlinePlus related topics: Depression
Drug Information available for: Ghrelin
U.S. FDA Resources
Study Type: Interventional
Study Design: Basic Science, Randomized, Single Blind (Subject), Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title: Effects of Ghrelin on the Sleep-EEG and Nocturnal Secretion of Hormones

Further study details as provided by Max-Planck-Institute of Psychiatry:

Primary Outcome Measures:
  • sleep, conventionally and quantitatively analyzed [ Time Frame: study duration ]

Secondary Outcome Measures:
  • 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
Intervention Details:
    Drug: ghrelin
    acylated ghrelin
  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00447512

Locations
Germany
Max Planck Institute of Psychiatry
Munich, Germany, 80804
Sponsors and Collaborators
Max-Planck-Institute of Psychiatry
German Research Foundation
Investigators
Principal Investigator: Professor Axel Steiger, MD Max-Planck-Institute of Psychiatry
  More Information

Study ID Numbers: L2/2003
Study First Received: March 13, 2007
Last Updated: October 29, 2007
ClinicalTrials.gov Identifier: NCT00447512  
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:
Depression
Mental Disorders
Mood Disorders
Healthy
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 16, 2009