Biological Triggers of Depression in Pregnancy

Completed

• Conditions: Mood Disorders; Other Perinatal Conditions; Depression and Suicide

• Registration Number: NCT02566980
• Lead Sponsor: Michigan State University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-10-23
• Study First Submitted: 2015-09-25
• Study First Submitted QC: 2015-10-01
• Study First Posted: 2015-10-02
• Primary Completion: 2017-02-28
• Study Completion: 2017-02-28
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-27
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 209

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increase in depressive symptoms	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)	Assessment of depressive symptoms by means of the Edinburgh Postnatal Depression Scale
Suicidal symptoms	Post-partum (within 6 months after delivery).	Assessment of suicidal symptoms by means of the Columbia Suicide Severity Rating Scale
Change in activity of the enzyme aminocarboxymuconate semialdehyde decarboxylase ACMSD in blood during pregnancy	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)	Blood levels of quinolinic acid and picolinic acid (product of ACMSD) at three timepoints during pregnancy and one time-point after pregnancy
Activity of the enzyme aminocarboxymuconate semialdehyde decarboxylase ACMSD in placenta	At delivery	Placenta levels of quinolinic acid and picolinic acid

Secondary Outcome Measures

Name	Time	Method
Change in blood inflammation	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)	Analysis of the inflammatory cytokine IL-6 in blood
Placenta inflammation	At delivery	Analysis of the expression of the inflammatory cytokine IL-6 in placental tissue

Trial Locations

Locations (3)

Spectrum Health System; 🇺🇸 Grand Rapids, Michigan, United States

Van Andel Research Institute; 🇺🇸 Grand Rapids, Michigan, United States

Pine Rest Christian Mental Health Services; 🇺🇸 Grand Rapids, Michigan, United States