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Completed

NCT Number: NCT01357083

The Study of Serum Melatonin Rhythm Levels in Patients With Major Depressive Disorder

One of the main points in the biological trends is, the circadian rhythm and disturbance in this cycle, which cause mood disorders and irregularity in this bio clock, to get depression. The pineal gland with the precise regulation of circadian rhythm of melatonin regulates the brain haemostasis. The abnormal function of this gland gives rise to psychiatric disorders.

In the period of youth and early of middle-age cause biochemical changes and disturbance in biorhythm including melatonin secretion.

This process can change the peak of melatonin phase. In addition, a decrease in the level of serum melatonin, can change the function of immune system of depressed patients. This function facilitates the process of cancerous cell formation and tumor growth.

With respect to the conflicting results and that the positive and negative roles of melatonin in the creation of depression is unknown, the aim of this study was to compare the morning and nocturnal serum melatonin rhythm levels in the patients with Major Depressive Disorder. The second purpose was to measure the morning and nocturnal serum melatonin levels in the depressed and healthy men and women.

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Key information

Age range

22 year–48 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shahnaz Khaleghipour

Isfahan, 81989, Iran

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • age: 22-48 years old
  • gender: male, female
  • who got a depressive score above 20, were included in the depressed group
  • those who obtained a depressive score below 9, were chosen and they were included in the healthy control group.
  • the healthy control group to match to the depressed patients for education, social occasion, occupational and economical situation.
  • the depression disorder was confirmed on the basis of the DSM criteria

Exclusion criteria

  • present or past psychiatric
  • physical diagnoses
  • drug consumption
  • use of narcotic substances
  • physical and psychosomatic disorders
  • the stressor
  • malfunction of thyroid gland
  • shift working

Treatment and study plan

Primary outcomes

  1. Depression status(measured by Beck depression inventory (BDII-II))

    Time frame: 2weeks

Secondary outcomes

  1. Measurements of morning and nocturnal melatonin levels by ELISA kit (cat no. RE54021) from the IBL-Hamburg.

    Time frame: 1 week

    The blood vein (5 milliliters) was taken from two groups at 8:00 am on a particular day. At the end of the same day and 24:00 h, the subjects were retaken the blood samples under the dim light.

Sponsors and collaborators

Lead sponsor

Science & Research Islamic Azad University Branch Khozestan

Other

Registry information

Official study title

The Study of Morning and Nocturnal Serum Melatonin Rhythm Levels in Patients With Major Depressive Disorder

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 20, 2011
Registry last updated
May 20, 2011

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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