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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01357083
• Other study ID #: 9460
• Secondary ID: CCT-NAPN-21087
• Status: Completed
• Phase: N/A
• First received: May 10, 2011
• Last updated: May 19, 2011
• Start date: August 2010
• Est. completion date: October 2010

Study information

• Verified date: August 2009
• Source: Science & Research Islamic Azad University Branch Khozestan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 48 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shahnaz Khaleghipour	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Science & Research Islamic Azad University Branch Khozestan

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression status(measured by Beck depression inventory (BDII-II))		2weeks
Secondary	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.	1 week