Postpartum DepressionNCT02682004
Serotonin, Leptin and Adiponectin Level in Patients With Postpartum Depression: Controlled Study
An observational study of Postpartum Depression, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
Trial summary
After vaginal delivery, all of the participants will evaluate by using Edinburg depression scale and venous blood sample will obtain. Postpartum depression will consider the result of scale 13 and above according to Turkhish translate. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Depression
- What is being tested?
- leptin, serotonin and adiponectin level and leptin,serotonin, adiponectin level
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2016to May 2017
- 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: According to Edinburg depression scale womenn who taken 13 point and above.
Who may be able to join
- All women who gave birth
Who cannot join
- women with previously diagnosed depression and any psychiatric disorders
- women with previously take antidepressan and antipshycothic
- women giving birth to children with anomalies
- women with undertake surgery for peripartum hemorrhage
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zeynep Kamil Maternity and Pediatric Research and Training Hospital
Istanbul, 34668
About this study
After vaginal delivery, all of the participants will evaluate by using Edinburg depression scale and venous blood sample will obtain. Postpartum depression will consider the result of scale 13 and above according to Turkhish translate. Then leptin, adiponectin and serotonin level will compare between depressed and nondepressed women.
- Conditions
- Postpartum Depression
- Being tested
- leptin, serotonin and adiponectin level, leptin,serotonin, adiponectin level
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leptin, serotonin and adiponectin levelOther
leptin,serotonin, adiponectin levelOther
| Study group | Role | What they receive |
|---|---|---|
| Women with postpartum depression | Not described Receives: Other: leptin, serotonin and adiponectin level | |
| Women without postpartum depression | Not described Receives: Other: leptin,serotonin, adiponectin level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood level (ng/ml) ELİSA
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionApr 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Postpartum DepressionStudies 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
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Baki Senturk, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02682004
- Sponsor's protocol ID
- 51
- Status last verified
- Mar 2022
- First submitted
- 10 Feb 2016
- Last updated
- 15 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hu Y, Dong X, Chen J. Adiponectin and depression: A meta-analysis. Biomed Rep. 2015 Jan;3(1):38-42. doi: 10.3892/br.2014.372. Epub 2014 Oct 16.
PubMed 25469244Skalkidou A, Sylven SM, Papadopoulos FC, Olovsson M, Larsson A, Sundstrom-Poromaa I. Risk of postpartum depression in association with serum leptin and interleukin-6 levels at delivery: a nested case-control study within the UPPSAT cohort. Psychoneuroendocrinology. 2009 Oct;34(9):1329-37. doi: 10.1016/j.psyneuen.2009.04.003. Epub 2009 May 7.
PubMed 19427131Mansur RB, Rizzo LB, Santos CM, Asevedo E, Cunha GR, Noto MN, Pedrini M, Zeni M, Cordeiro Q, McIntyre RS, Brietzke E. Adipokines, metabolic dysfunction and illness course in bipolar disorder. J Psychiatr Res. 2016 Mar;74:63-9. doi: 10.1016/j.jpsychires.2015.12.003. Epub 2015 Dec 12.
PubMed 26748249
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serotonin, Leptin and Adiponectin Level in Patients With Postpartum Depression: Controlled Study
- ClinicalTrials.gov ID
- NCT02682004
- Acronym / sponsor ID
- 51
- Conditions
- Postpartum Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Zeynep Kamil Maternity and Pediatric Research and Training HospitalUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 15 Feb 2016 (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.
After vaginal delivery, all of the participants will evaluate by using Edinburg depression scale and venous blood sample will obtain. Postpartum depression will consider the result of scale 13 and above according to Turkhish translate. Then leptin, adiponectin and serotonin level will compare between depressed and nondepressed women.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with postpartum depression | – | Other: leptin, serotonin and adiponectin level |
| Women without postpartum depression | – | Other: leptin,serotonin, adiponectin level |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- According to Edinburg depression scale womenn who taken 13 point and above.
Key inclusion criteria (1 listed)
- All women who gave birth
Key exclusion criteria (4 listed)
- women with previously diagnosed depression and any psychiatric disorders
- women with previously take antidepressan and antipshycothic
- women giving birth to children with anomalies
- women with undertake surgery for peripartum hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| leptin, serotonin and adiponectin level | Other | Women with postpartum depression |
| leptin,serotonin, adiponectin level | Other | Women without postpartum depression |
Primary outcome
Blood level (ng/ml) ELİSA
Time frame: 1 month
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 15 Mar 2022.
- Results publication: PubMed 25469244Hu Y, Dong X, Chen J. Adiponectin and depression: A meta-analysis. Biomed Rep. 2015 Jan;3(1):38-42. doi: 10.3892/br.2014.372. Epub 2014 Oct 16.
- Results publication: PubMed 19427131Skalkidou A, Sylven SM, Papadopoulos FC, Olovsson M, Larsson A, Sundstrom-Poromaa I. Risk of postpartum depression in association with serum leptin and interleukin-6 levels at delivery: a nested case-control study within the UPPSAT cohort. Psychoneuroendocrinology. 2009 Oct;34(9):1329-37. doi: 10.1016/j.psyneuen.2009.04.003. Epub 2009 May 7.
- Results publication: PubMed 26748249Mansur RB, Rizzo LB, Santos CM, Asevedo E, Cunha GR, Noto MN, Pedrini M, Zeni M, Cordeiro Q, McIntyre RS, Brietzke E. Adipokines, metabolic dysfunction and illness course in bipolar disorder. J Psychiatr Res. 2016 Mar;74:63-9. doi: 10.1016/j.jpsychires.2015.12.003. Epub 2015 Dec 12.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Postpartum Depression, run by Zeynep Kamil Maternity and Pediatric Research and Training Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 4 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 15 Mar 2022. 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 Turkey (Türkiye). 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?
Blood level (ng/ml) ELİSA (time frame: 1 month). 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 NCT02682004, which also lists 3 linked publications.
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 15 Mar 2022.