Major Depressive DisorderNCT01357083
The Study of Serum Melatonin Rhythm Levels in Patients With Major Depressive Disorder
An observational study of Major Depressive Disorder, run by Science & Research Islamic Azad University Branch Khozestan at 1 site in Iran.
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. Read more about this study
- Who is it for?
- Ages 22 to 48 yearsHealthy volunteers can take part
- Conditions the study is for
- Major Depressive Disorder
- How many people
- 92 participants
- Where
- 1 siteIran
- Study dates
- Aug 2010to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 48 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The individuals were chosen who referred to the industrial medical unit of one of big company.
Who may be able to join
- 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
Who cannot join
- present or past psychiatric
- physical diagnoses
- drug consumption
- use of narcotic substances
- physical and psychosomatic disorders
- the stressor
- malfunction of thyroid gland
- shift working
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- Major Depressive Disorder
- Keywords
- Melatonin, Periodicity, Depressive disorder, major, Serum, Depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Depression status(measured by Beck depression inventory (BDII-II))
Measured: 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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2011 (estimated)
- Study startAug 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Science & Research Islamic Azad University Branch Khozestan
- Sponsor type
- University, hospital or other
- Investigators
- Shahnaz Khaleghipour, PhD, Principal investigator, Science and Research Branch Islamic Azad University Khozestan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01357083
- Sponsor's protocol ID
- 9460
- Other IDs
- CCT-NAPN-21087
- Status last verified
- Aug 2009
- First submitted
- 10 May 2011
- Last updated
- 20 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Morning and Nocturnal Serum Melatonin Rhythm Levels in Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01357083
- Acronym / sponsor ID
- 9460
- Conditions
- Major Depressive Disorder
- Keywords
- Melatonin, Periodicity, Depressive disorder, major, Serum, Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Science & Research Islamic Azad University Branch KhozestanUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 20 May 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 . |
Who may qualify
- Ages
- 22 to 48 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The individuals were chosen who referred to the industrial medical unit of one of big company.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- present or past psychiatric
- physical diagnoses
- drug consumption
- use of narcotic substances
- physical and psychosomatic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Depression status(measured by Beck depression inventory (BDII-II))
Time frame: 2weeks
1 secondary outcome
Measurements of morning and nocturnal melatonin levels by ELISA kit (cat no. RE54021) from the IBL-Hamburg.
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2011.
- Derived from this study: PubMed 22790549Khaleghipour 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.
Related trials for Major Depressive Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shahnaz Khaleghipour, PhD principal investigator
Science and Research Branch Islamic Azad University Khozestan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder, run by Science & Research Islamic Azad University Branch Khozestan at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression status(measured by Beck depression inventory (BDII-II)) (time frame: 2weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01357083, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2011.