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Completed

NCT Number: NCT02566980

Biological Triggers of Depression in Pregnancy

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Pre-partum cohort:

  • All races and national origins of pregnant females.
  • Age 18 and older.
  • English speaking.
  • Able to give informed consent.
  • Able to comply with study procedures.

Exclusion criteria

Pre-partum cohort:

  • Non-pregnant females
  • Patients with psychotic symptoms and/or severe cognitive impairment that interfere with their ability to give informed consent or to complete study assessments.
  • Patients that cannot read and write in English as research measures used have only been validated in English speaking populations.
  • Patients that have blood-borne chronic infections including hepatitis B, C, or HIV as established at routine pregnancy blood screens; they will be excluded as the laboratory facilities do not approve processing of their tissue for safety reasons.
  • Patients who have any schizophrenia spectrum disorder or bipolar disorder type 1 (based on self report and SCID interview); these patients will be excluded as the neurobiology of these disorders are different from peripartum depression.
  • Patients who report ongoing substance abuse or dependence (in the past 3 months).

Inclusion criteria

Post-partum cohort:

  • All races and national origins of females who delivered a child vaginally or by caesarian section up to 6 months prior to enrollment.
  • Age 18 and older.
  • Edinburgh Perinatal Depression Rating Scale score of 10 and above and/or endorsed suicide ideation on the CSSRS.
  • Depressive symptoms which began or worsened (if already present) during pregnancy or up to 4 weeks post-partum.
  • Able to give informed consent.
  • Able to comply with and complete study procedures.
  • English speaking.

Exclusion criteria

Post-partum cohort:

  • Patients with psychotic symptoms and/or severe cognitive impairment that interfere with their ability to give informed consent or to complete study assessments.
  • Patients who cannot read and write in English as research measures used have only been validated in English speaking populations.
  • Patients that have blood-borne chronic infections including hepatitis B, C, or HIV; as established at their routine pregnancy blood screens.
  • Patients who have any schizophrenia spectrum disorder or bipolar type 1 (based on the self report and SCID interview).
  • Patients who report ongoing substance abuse or dependence (past 3 months).

Treatment and study plan

Primary outcomes

  1. Change in activity of the enzyme aminocarboxymuconate semialdehyde decarboxylase ACMSD in blood during 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)

    Blood levels of quinolinic acid and picolinic acid (product of ACMSD) at three timepoints during pregnancy and one time-point after pregnancy

  2. Activity of the enzyme aminocarboxymuconate semialdehyde decarboxylase ACMSD in placenta

    Time frame: At delivery

    Placenta levels of quinolinic acid and picolinic acid

  3. Increase in depressive symptoms

    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)

    Assessment of depressive symptoms by means of the Edinburgh Postnatal Depression Scale

  4. Suicidal symptoms

    Time frame: Post-partum (within 6 months after delivery).

    Assessment of suicidal symptoms by means of the Columbia Suicide Severity Rating Scale

Secondary outcomes

  1. Change in blood inflammation

    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)

    Analysis of the inflammatory cytokine IL-6 in blood

  2. Placenta inflammation

    Time frame: At delivery

    Analysis of the expression of the inflammatory cytokine IL-6 in placental tissue

Sponsors and collaborators

Lead sponsor

Michigan State University

Other

Collaborators

  • Corewell Health West
  • National Institute of Mental Health (NIMH)
  • Pine Rest Christian Mental Health Services
  • Van Andel Research Institute

Registry information

Official study title

The Role of Kynurenine Pathway Metabolites in Perinatal Depression and Suicidality

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 2, 2015
Registry last updated
Jun 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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