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

Primary Purpose

Healthy, Major Depression

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ghrelin
Sponsored by
Max-Planck-Institute of Psychiatry
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Max Planck Institute of Psychiatry

Outcomes

Primary Outcome Measures

sleep, conventionally and quantitatively analyzed

Secondary Outcome Measures

hormones of the hypothalamic-pituitary-adrenocortical (HPA) axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis

Full Information

First Posted
March 13, 2007
Last Updated
October 29, 2007
Sponsor
Max-Planck-Institute of Psychiatry
Collaborators
German Research Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00447512
Brief Title
Effects of Ghrelin on the Sleep-EEG and Nocturnal Secretion of Hormones
Official Title
Effects of Ghrelin on the Sleep-EEG and Nocturnal Secretion of Hormones
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Max-Planck-Institute of Psychiatry
Collaborators
German Research Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Major Depression

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
ghrelin
Intervention Description
acylated ghrelin
Primary Outcome Measure Information:
Title
sleep, conventionally and quantitatively analyzed
Time Frame
study duration
Secondary Outcome Measure Information:
Title
hormones of the hypothalamic-pituitary-adrenocortical (HPA) axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis
Time Frame
study duration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Professor Axel Steiger, MD
Organizational Affiliation
Max-Planck-Institute of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Max Planck Institute of Psychiatry
City
Munich
ZIP/Postal Code
80804
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22259063
Citation
Kluge M, Schussler P, Schmidt D, Uhr M, Steiger A. Ghrelin suppresses secretion of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) in women. J Clin Endocrinol Metab. 2012 Mar;97(3):E448-51. doi: 10.1210/jc.2011-2607. Epub 2012 Jan 18.
Results Reference
derived

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

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