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Completed

NCT Number: NCT00447512

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

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).

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Key information

Conditions

Healthy Depressive Disorder Depressive Disorder, Major Major Depression Mental Disorders Mood Disorders

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Max Planck Institute of Psychiatry

Munich, 80804, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ghrelin

Drug

acylated ghrelin

Primary outcomes

  1. sleep, conventionally and quantitatively analyzed

    Time frame: study duration

Secondary outcomes

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

    Time frame: study duration

Sponsors and collaborators

Lead sponsor

Max-Planck-Institute of Psychiatry

Other

Collaborators

  • German Research Foundation

Registry information

Important dates

Study start
2004
Study completion
2007
First posted
Mar 14, 2007
Registry last updated
Oct 31, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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