An observational study in Depression and Suicide, Mood Disorders and Other Perinatal Conditions, sponsored by Michigan State University. Completed at 3 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-28.
Sponsored by Michigan State University · Observational
The goal of the study is to define and measure biological processes that contribute to the underlying pathophysiologic process of peri-partum depression to be used for identifying those at risk for developing it. This knowledge may also generate novel drug targets for peripartum depression that may be applicable to other types of depression.
This study analyses the role of inflammation and metabolites of inflammation in perinatal depression. Psychiatric assessments of depression and suicidality will be compared to blood levels of two metabolites of inflammation, quinolinic acid (QUIN) and picolinic acid (PIC), that might regulate nerve cell communication. The levels of these metabolites are regulated by kynurenine pathway enzymes.
Psychiatric symptoms, inflammatory cytokines and levels of the metabolites will be measured throughout pregnancy. Additionally, the investigators are gathering placentas at delivery and determining the degree of inflammation in the tissue in the investigators' laboratory. Inflammatory biomarkers, antibody titers, and key kynurenine pathway enzymes and metabolites from pre- and post partum women, placenta, and cord blood will be measured.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's enrollment of 209 is above the median of 160 across 1,084 observational studies indexed under Depression.
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Pregnant females age 18 and older, psychiatrically healthy or depressed; post-partum females experiencing perinatal depression with and without suicide ideation.
Inclusion Criteria
Pre-partum cohort:
Exclusion Criteria
Pre-partum cohort:
Inclusion criteria
Post-partum cohort:
Exclusion criteria
Post-partum cohort:
130 pregnant women will be enrolled in first trimester. Healthy women or those with any degree of depressive symptoms are eligible. Blood samples and psychiatric assessments will take place once every trimester and once in the post-partum. At delivery placenta will be collected. Enrollment takes place at Spectrum Health Ob/gyn out-patient clinics in Grand Rapids, Michigan.
50-100 women experiencing perinatal depression with and without suicidality will be enrolled from a partial hospitalization program, the Mother and Baby unit as well as outpatient clinics at Pine Rest Christian Mental Health Services, Grand Rapids, Michigan.
Change in activity of the enzyme aminocarboxymuconate semialdehyde decarboxylase ACMSD in blood during pregnancy
Blood levels of quinolinic acid and picolinic acid (product of ACMSD) at three timepoints during pregnancy and one time-point after pregnancy
Time frame: Up to pregnancy week 13 (1st sample), up to week 25 (second sample) and up to delivery (3rd sample) and post-partum (4th sample, within 6 months after delivery)
Activity of the enzyme aminocarboxymuconate semialdehyde decarboxylase ACMSD in placenta
Placenta levels of quinolinic acid and picolinic acid
Time frame: At delivery
Increase in depressive symptoms
Assessment of depressive symptoms by means of the Edinburgh Postnatal Depression Scale
Time frame: Up to pregnancy week 13 (1st assessment), up to week 25 (second assessment) and up to delivery (3rd assessment) and post-partum (4th assessment, within 6 months after delivery)
Suicidal symptoms
Assessment of suicidal symptoms by means of the Columbia Suicide Severity Rating Scale
Time frame: Post-partum (within 6 months after delivery).
Change in blood inflammation
Analysis of the inflammatory cytokine IL-6 in blood
Time frame: Up to pregnancy week 13 (1st sample), up to week 25 (second sample) and up to delivery (3rd sample) and post-partum (4th sample, within 6 months after delivery)
Placenta inflammation
Analysis of the expression of the inflammatory cytokine IL-6 in placental tissue
Time frame: At delivery
Plan to share: No
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Michigan State University