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

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Depression

Study type: Observational

Funder types: Industry

Identifiers

NCT03144752

CR108271

NAPND0001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 298 patients

Sex: Female

Ages: 18 to 44 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

298 participants in 2 patient groups

Cohort 1: Participants between 8 to 14 weeks gestation

Description:

Cohort 1 will include female participants who present for the first prenatal visit which takes place between Weeks 8 and 14 at maternity practices associated with University of North Carolina (UNC) Women's Care. Biomarkers, medical and psychiatric history, and psychosocial measures will be evaluated and utilized in developing a predictive risk algorithm for perinatal depression.

Cohort 2: Participants between 15 to 36 weeks gestation

Description:

Cohort 2 will include female participants enrolled at various points in their pregnancy from Week 15 up through 36 weeks gestation. Biomarkers, medical and psychiatric history, and psychosocial measures will be evaluated and utilized in developing a predictive risk algorithm for perinatal depression.