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

The Study of Morning and Nocturnal 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.

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Anticipated)

92

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 48 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Depression status(measured by Beck depression inventory (BDII-II))
Time Frame: 2weeks
2weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Shahnaz Khaleghipour, PhD, Science and Research Branch Islamic Azad University Khozestan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

May 10, 2011

First Submitted That Met QC Criteria

May 19, 2011

First Posted (Estimate)

May 20, 2011

Study Record Updates

Last Update Posted (Estimate)

May 20, 2011

Last Update Submitted That Met QC Criteria

May 19, 2011

Last Verified

August 1, 2009

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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