Clinical trial NCT03144752: Optimizing Clinical Screening and Management of Maternal Mental Health: Predicting Women at Risk for Perinatal Depression
Official title: Optimizing Clinical Screening and Management of Maternal Mental Health: Predicting Women at Risk for Perinatal Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2017-05-09
Enrollment: 298
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 300 pregnant women seeking maternal healthcare services in a department of Obstetrics and Gynecology at the University of North Carolina health center will be observed for perinatal depression.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Biomarker Assessment for Perinatal Depression
timeFrame: Up to Visit 3 (Weeks 36-40 of gestation)
measure: Medical and Psychiatric History
timeFrame: Visit 1 (anywhere between Weeks 8-36 of gestation)
measure: Maternity Social Support Scale (MSSS) Score
timeFrame: Up to 24-26 weeks postpartum
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Up to 24-26 weeks postpartum
measure: Perceived Stress Scale (PSS)
timeFrame: Up to 24-26 weeks postpartum
measure: State-trait Anxiety Inventory (STAI)
timeFrame: Up to 24-26 weeks postpartum
measure: Obsessive Compulsive Inventory - Revised (OCI-R)
timeFrame: Up to 24-26 weeks postpartum
measure: Patient-Reported Outcomes Measurement Information System (PROMIS)- Pain Interference
timeFrame: Up to 8-9 weeks postpartum
measure: PROMIS-Sleep Disturbance
timeFrame: Up to 24-26 weeks postpartum
measure: PROMIS-Sleep Related Impairment
timeFrame: Up to 24-26 weeks postpartum
measure: PROMIS-Self Efficacy
timeFrame: Up to 24-26 weeks postpartum
measure: Patient Health Questionnaire-2 (PHQ-2)
timeFrame: Up to 24-26 weeks postpartum
measure: Perinatal Post-traumatic Stress Disorder (PTSD) Questionnaire - Modified (PPQ)
timeFrame: At 12-14 weeks postpartum
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Up to 24-26 weeks postpartum
measure: Pregnancy-Unique Quantification of Emesis and Nausea - Modified (PUQE)
timeFrame: Up to 24-25 weeks
measure: Infant Feeding Intentions Scale (IFI)
timeFrame: At 24-25 weeks
measure: Neonatal Breastfeeding Questionnaire
timeFrame: At 5-9 days postpartum
measure: Postnatal Breastfeeding Questionnaire
timeFrame: At 24-26 weeks postpartum
Secondary outcomes:
measure: Incidence of Perinatal Depression (PND)
timeFrame: Up to 60 weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: