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

This study has been completed.
Sponsor:
Information provided by:
Science & Research Islamic Azad University Branch Khozestan
ClinicalTrials.gov Identifier:
NCT01357083
First received: May 10, 2011
Last updated: May 19, 2011
Last verified: August 2009
  Purpose

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.


Condition
Major Depressive Disorder

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: The Study of Morning and Nocturnal Serum Melatonin Rhythm Levels in Patients With Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Science & Research Islamic Azad University Branch Khozestan:

Primary Outcome Measures:
  • Depression status(measured by Beck depression inventory (BDII-II)) [ Time Frame: 2weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurements of morning and nocturnal melatonin levels by ELISA kit (cat no. RE54021) from the IBL-Hamburg. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 92
Study Start Date: August 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/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 .

  Eligibility

Ages Eligible for Study:   22 Years to 48 Years
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01357083

Locations
Iran, Islamic Republic of
Shahnaz Khaleghipour
Isfahan, Iran, Islamic Republic of, 81989
Sponsors and Collaborators
Science & Research Islamic Azad University Branch Khozestan
Investigators
Principal Investigator: Shahnaz Khaleghipour, PhD Science and Research Branch Islamic Azad University Khozestan
  More Information

No publications provided by Science & Research Islamic Azad University Branch Khozestan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: shahnaz Khaleghipour, Science & Research Islamic Azad University Branch Khozestan
ClinicalTrials.gov Identifier: NCT01357083     History of Changes
Other Study ID Numbers: 9460, CCT-NAPN-21087
Study First Received: May 10, 2011
Last Updated: May 19, 2011
Health Authority: Iran: Ethics Committee

Keywords provided by Science & Research Islamic Azad University Branch Khozestan:
Melatonin
Periodicity
Depressive disorder, major
Serum
Depression

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Disease
Mood Disorders
Mental Disorders
Behavioral Symptoms
Pathologic Processes
Melatonin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014