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

Not Applicable

Completed

• Conditions: Healthy; Major Depression

• Registration Number: NCT00447512
• Lead Sponsor: Max-Planck-Institute of Psychiatry

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2007-03-13
• Study First Submitted QC: 2007-03-13
• Study First Posted: 2007-03-14
• Status Verified: 2007-10
• Study Completion: 2007-10
• Last Update Submitted: 2007-10-29
• Last Update Posted: 2007-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
sleep, conventionally and quantitatively analyzed	study duration

Secondary Outcome Measures

Name	Time	Method
hormones of the hypothalamic-pituitary-adrenocortical (HPA) axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis	study duration

Trial Locations

Locations (1)

Max Planck Institute of Psychiatry; 🇩🇪 Munich, Germany