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

• Sponsor: Max-Planck-Institute of Psychiatry (Other)
• Overall Status: Completed
• CT.gov ID: NCT00447512
• Collaborator: German Research Foundation (Other)
• Enrollment: 80
• Location: 1
• Duration (Months): 43
• Patients Per Site Per Month: 1.9

Study Details

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:

1. 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).

2. 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 or Disease	Intervention/Treatment	Phase
Healthy; Major Depression	Drug: ghrelin	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Effects of Ghrelin on the Sleep-EEG and Nocturnal Secretion of Hormones
• Study Start Date: Mar 1, 2004
• Actual Study Completion Date: Oct 1, 2007

Outcome Measures

Primary Outcome Measures

1. sleep, conventionally and quantitatively analyzed [study duration]

Secondary Outcome Measures

1. hormones of the hypothalamic-pituitary-adrenocortical (HPA) axis, the gonadotropic axis and the hypothalamic-pituitary-gonadal axis [study duration]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00447512
• Other Study ID Numbers: L2/2003
• First Posted: Mar 14, 2007
• Last Update Posted: Oct 31, 2007
• Last Verified: Oct 1, 2007

• Additional relevant MeSH terms: Depressive Disorder, Major

Study Results

No Results Posted as of Oct 31, 2007