- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01357083
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
Conditions
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Isfahan, Iran, Islamic Republic of, 81989
- Shahnaz Khaleghipour
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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 .
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Depression status(measured by Beck depression inventory (BDII-II))
Time Frame: 2weeks
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2weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Measurements of morning and nocturnal melatonin levels by ELISA kit (cat no. RE54021) from the IBL-Hamburg.
Time Frame: 1 week
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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.
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1 week
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Collaborators and Investigators
Investigators
- Principal Investigator: Shahnaz Khaleghipour, PhD, Science and Research Branch Islamic Azad University Khozestan
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9460 (CTEP)
- CCT-NAPN-21087
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