Effects of Ghrelin on the Sleep-EEG and Nocturnal Secretion of Hormones

This study has been completed.
Sponsor:
Collaborator:
German Research Foundation
Information provided by:
Max-Planck-Institute of Psychiatry
ClinicalTrials.gov Identifier:
NCT00447512
First received: March 13, 2007
Last updated: October 29, 2007
Last verified: October 2007
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 September 14, 2014