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Biological Triggers of Depression in Pregnancy

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ClinicalTrials.gov Identifier: NCT02566980
Recruitment Status : Completed
First Posted : October 2, 2015
Last Update Posted : June 28, 2018
Sponsor:
Collaborators:
Pine Rest Christian Mental Health Services
Van Andel Research Institute
Spectrum Health Hospitals
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Lena Brundin, 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.

Condition or disease
Depression and Suicide Mood Disorders Other Perinatal Conditions

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 Type : Observational
Actual Enrollment : 209 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Kynurenine Pathway Metabolites in Perinatal Depression and Suicidality
Actual Study Start Date : October 23, 2014
Actual Primary Completion Date : February 28, 2017
Actual Study Completion Date : February 28, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Pre-partum
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.
Post-partum
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Adult Blood Cord Blood Placenta


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pregnant females age 18 and older, psychiatrically healthy or depressed; post-partum females experiencing perinatal depression with and without suicide ideation.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02566980


Locations
United States, Michigan
Spectrum Health System
Grand Rapids, Michigan, United States, 49503
Van Andel Research Institute
Grand Rapids, Michigan, United States, 49503
Pine Rest Christian Mental Health Services
Grand Rapids, Michigan, United States, 49548
Sponsors and Collaborators
Michigan State University
Pine Rest Christian Mental Health Services
Van Andel Research Institute
Spectrum Health Hospitals
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Lena Brundin, MD, PhD Michigan State University, Van Andel Research Institute

Additional Information:
Publications:
National Institute of Mental Health (NIMH), Statistics Use of Mental Health Services and Treatment among Adults. Availabe on-line at http://www.nimh.nih.gov/statistics/3USE_MT_ADULT.shtml.
World Health Organization (WHO). What Is Depression. Available on-line at http://www.who.int/mental_health/management/depression/definition/en/
First MB, Spitzer RL, Gibbon M, Williams JBW. Structured Clinical Interview for DSM-IV Axis I Disorders - Patient Edition (SCID-I/P, Version 2.0), Biometrics Research Department, New York State Psychiatric Institute, 1995.

Responsible Party: Lena Brundin, Associate Professor, Division of Psychiatry and Behavioral Medicine, Michigan State University
ClinicalTrials.gov Identifier: NCT02566980     History of Changes
Other Study ID Numbers: 14-458M
1R01MH104622-01 ( U.S. NIH Grant/Contract )
First Posted: October 2, 2015    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Lena Brundin, Michigan State University:
depression
mood disorder
post-partum depression
suicidality
post-partum suicidality
perinatal depression
perinatal mood disorder
inflammation
kynurenine pathway
glutamate

Additional relevant MeSH terms:
Depression
Depressive Disorder
Suicide
Mood Disorders
Behavioral Symptoms
Mental Disorders
Self-Injurious Behavior