NL-OMON56412尚未招募不适用
PANDA-study - Prenatal And Neonatal Development: An offspring study of severe mental illness - PANDA-study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 125
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0 至 64（—）
入选标准
- •All pregnant women and their partners:
- •At least 18 years old
- •Ability to provide informed consent
- •Singleton pregnancy
- •Biological parent of the fetus/neonate
- •Pregnant women and their partners with at least one (future) parent with SMI:
- •At least one (future) parent with SMI in the mood-psychosis spectrum
- •diagnosed before current pregnancy, i.e., schizophrenia, bipolar disorder,
- •severe MDD (i.e., with high recurrence rate and/or hospitalizations), psychosis
- •NOS, single psychosis < two years ago (not related to drug use; no postpartum
- •psychosis after a prior pregnancy)
- •Born from parents who participated in visit 1 and/or 2 or born from parents
- •who would have qualified for inclusion in the study (in other words, families
- •can also only participate in visit 3).
排除标准
- •All pregnant women:
- •Contraindication for MRI (including claustrophobia, a cardiac implantable
- •electronic device, ferromagnetic metal implants, piercing (in some cases),
- •tattoos (in some cases)) (Ghadimi & Sapra, 2022).
- •Postpartum psychosis (after a prior pregnancy)
- •Not willing to be informed about incidental findings following MRI assessment
- •All pregnant women and their partners:
- •Substance use disorder (alcohol, drugs), active < six months pre pregnancy as
- •assessed with R4U or current addiction treatment such as methadone or
- •buprenorphine
- •Not willing to be informed about neonate*s incidental findings following MRI
- •All fetuses/neonates:
- •Preeclampsia or fetal growth restriction at time of inclusion
- •Neurological illness or structural brain abnormalities
- •Suspected congenital anomalies or syndromes known to affect neurodevelopment
- •Chromosomal abnormalities
- •Genetic abnormalities known to impact neurodevelopment
- •Premature birth (< 37 weeks)
- •Pregnant women and their partners without SMI:
- •A lifetime diagnosis of SMI in the mood-psychosis spectrum as assessed with
- •the Structured Clinical Interview for DSM-5 (SCID-5; First, 2014).
- •An SMI in the mood-psychosis spectrum in their first degree relatives
- •Use of neurotrophic medication
- •In all (future) parents, (co)morbidity with other psychiatric diagnoses is not
- •an exclusion criterion.
研究者
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