Biological Triggers of Depression in Pregnancy
Completed
Conditions studied: Depression and Suicide, Mood Disorders, Other Perinatal Conditions
In brief
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.
Key facts
- Study ID
- NCT02566980
- Run by
- Michigan State University
- People needed
- 209
- Starts
- 2014-10-23
- Expected to finish
- 2017-02-28
- Last updated by the study team
- 2018-06-28
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- 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
Full record on ClinicalTrials.gov
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