Comparing Effectiveness of Treating Depression With & Without Comorbidity to Improve Fetal Health

Depression Clinical Trial

— PCORIPTD  

Official title:

Comparing Effectiveness of Treating Depression With & Without Comorbidity to Improve Fetal Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02371356
• Other study ID #: CN-13-1650-H
• Status: Completed
• Start date: May 2014
• Est. completion date: April 30, 2019

Study information

• Verified date: March 2020
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Depression during pregnancy is prevalent (15-20%) and has an adverse impact on fetal outcomes including preterm delivery (PTD) and low birthweight (LBW). Currently, significant confusion exists about if and how depression during pregnancy should be treated, given the unknown risk-benefit profiles of various treatments. We propose to conduct a two-stage prospective cohort study to determine if treating depression in pregnancy is effective in improving fetal outcomes, and which treatment is most effective: pharmacotherapy, psychotherapy or a combination. The risk-benefit of the treatments will be examined separately for two depression types: pregnant women with depression only and those with other psychiatric comorbidities to evaluate possible differences in treatment effectiveness between the two groups. Findings will provide answers to long standing stakeholder questions of how to treat depression in pregnancy and which treatment is most effective with the best risk-benefit profile in improving fetal outcomes. Selecting an effective treatment could reduce PTD or LBW, thus, reducing infant mortality and morbidity, and medical costs.

Description:

Depression during pregnancy is prevalent (15-20%) and has an adverse impact on fetal outcomes including preterm delivery (PTD) and low birthweight (LBW). Currently, significant confusion exists about if and how depression during pregnancy should be treated, given the unknown risk-benefit profiles of various treatments. Kaiser Permanente Northern California has implemented a large scale universal peripartum depression screening program, annually screening more than 35,000 pregnant women. Taking advantage of this unique infrastructure, we propose to conduct a two-stage prospective cohort study to determine if treating depression in pregnancy is effective in improving fetal outcomes, and which treatment is most effective: pharmacotherapy, psychotherapy or a combination. The risk-benefit of the treatments will be examined separately for two depression types: pregnant women with depression only and those with other psychiatric comorbidities to evaluate possible differences in treatment effectiveness between the two groups. Stakeholders (patients, advocacy groups, and providers) are an integral part of the research team. Four cohorts with different treatment options including untreated will be formed within each depression type (with or without comorbidity): (A) "Antidepressant only": screen positive for depression and use only antidepressants during pregnancy; (B) "Psychotherapy only": screen positive and receive psychotherapy only; (C) "Combination therapy": screen positive and receive both antidepressants and psychotherapy; (D)"Untreated depression": screen positive and receive no treatment. A total of eight cohorts will be formed. A final cohort (E) "No depression": screen negative and receive no treatment, will be examined for baseline comparison. Information on depression treatment and PTD and LBW will be available for all participating women who will be followed until the end of pregnancy. Within each depression category, comparison of Cohort A, B & C to D, respectively, will determine if treating depression is effective. Pair-wise comparisons among Cohorts A, B & C will determine the comparative effectiveness of treatment regimens. Comparison of Cohort D to E provides baseline fetal risks of untreated depression. Findings will provide answers to long standing stakeholder questions of how to treat depression in pregnancy and which treatment is most effective with the best risk-benefit profile in improving fetal outcomes. Selecting an effective treatment could reduce PTD or LBW, thus, reducing infant mortality and morbidity, and medical costs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91084
• Est. completion date: April 30, 2019
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Kaiser member

• Pregnant

Exclusion Criteria:

• Not a member of Kaiser Permanente

• Not pregnant

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Premature Birth
• Preterm Delivery

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	Patient-Centered Outcomes Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preterm Delivery	Delivery prior to 37 completed weeks of gestational age	Through the end of pregnancy, an average of 40 weeks
Primary	Low Birth Weight	Birth weight <2500 grams	Through the end of pregnancy, an average of 40 weeks