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CompletedNCT01357083Updated May 20, 2011

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

An observational study in Major Depressive Disorder, sponsored by Science & Research Islamic Azad University Branch Khozestan. Completed at 1 site in Iran. Open to participants aged 22 Years to 48 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-05-20.

Sponsored by Science & Research Islamic Azad University Branch Khozestan · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
92
Ages
22 Years to 48 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Major Depressive Disorder

Keywords

  • Melatonin
  • Periodicity
  • Depressive disorder, major
  • Serum
  • Depression
03

In context

Depressive Disorder, Major

2,805 studies on the registry are indexed under Depressive Disorder, Major; 565 are open to participants now.

This study's planned enrollment of 92 is below the median of 135 across 365 observational studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

This is the only study on the registry with Science & Research Islamic Azad University Branch Khozestan as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
22 Years to 48 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

The individuals were chosen who referred to the industrial medical unit of one of big company.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. present or past psychiatric
  2. physical diagnoses
  3. drug consumption
  4. use of narcotic substances
  5. physical and psychosomatic disorders
  6. the stressor
  7. malfunction of thyroid gland
  8. shift working
05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
92 participants (estimated)

Groups and cohorts

  • Major Depression Disorder

    This study is analytical cross-sectional and randomized. Two groups of depressed patients and healthy subjects were selected.The individual were submitted to a medical examination, and responded to the Beck depression inventory (BDII-II). Those, who got a score above 20, were included in the depressed group. Among this group, 50 patients were chosen randomly. those who obtained a depressive score below 9, 50 of them were chosen and they were included in the healthy group. The control group was chosen to match to the depressed patients for education, social occasion, occupational and economical situation. All of the subjects were interviewed psychiatrically, and the depression disorder was confirmed on the basis of the DSM criteria. eight out of 50 depressed patients were excluded from the study due to suffering from other psychiatric disorders .

06

What researchers measure

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.

    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.

    Time frame: 1 week

07

Study locations

1 site
  • Shahnaz Khaleghipour
    Isfahan, Isfahan 81989, Iran
08

References and documents

Publications

  • Khaleghipour S, Masjedi M, Ahade H, Enayate M, Pasha G, Nadery F, Ahmadzade G. Morning and nocturnal serum melatonin rhythm levels in patients with major depressive disorder: an analytical cross-sectional study. Sao Paulo Med J. 2012;130(3):167-72. doi: 10.1590/s1516-31802012000300006. PubMed 22790549 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 20, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01357083
Lead sponsor
Science & Research Islamic Azad University Branch Khozestan
First posted
May 20, 2011
Start date
Aug 2010
Primary completion
Oct 2010
Completion
Oct 2010
Last update
May 20, 2011

Study contacts

Shahnaz Khaleghipour, PhD
principal investigator · Science and Research Branch Islamic Azad University Khozestan

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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