Optimizing Clinical Screening and Management of Maternal Mental Health: Predicting Women at Risk for Perinatal Depression

Completed

Conditions studied: Depression

In brief

The purpose of this study is to determine if medical, biological, psychological, and social risk factors can be used to develop algorithms that will predict perinatal depression (PND). Data capture will include baseline participant medical, psychological and family history, blood biomarkers, and psychosocial assessments.

Key facts

Study ID

NCT03144752

Run by

Janssen Research & Development, LLC

People needed

298

Starts

2017-04-14

Expected to finish

2019-05-05

Last updated by the study team

2019-07-19

Who can join

Age: 18 and older, up to 44. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Participants must be English-speaking and able to understand and follow clinician/researcher/provider recommendations
• Participants must be able to read and comprehend written communications (English) and physically able to complete electronic patient-reported outcome (ePRO) assessments
• Participants must have access to a personal smartphone or a computer and an active personal email address for which they are willing to use for data collection
• Each participant must sign an informed consent form (ICF) indicating that she understands the purpose of and procedures required for this study and is willing to participate in and comply with all procedures in the study
• Participant must be willing and able to have blood draws and to complete the self-reported assessments via mobile electronic device during the study

You may not qualify if…

• Participant is not English speaking
• Lifetime mood disorder other than major depressive disorder (MDD) (example [e.g.], bipolar I) or anxiety disorder
• Lifetime psychotic disorder (eg, schizophrenia, schizoaffective disorder)
• Lifetime alcohol or illicit substance dependence (moderate-severe)
• Current Post-traumatic Stress Disorder (PTSD), significant alcohol or illicit drug use (Ethanol [ETOH]/nonprescription drug use) within 12 months greater than or equal to (>=)occasional use

Where it is running

• University of North Carolina — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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