Survey on the Reproductive and Child-Rearing Situations o... | NCT07005245

Studies
Survey on the Reproductive and Child-Rearing Situations of Patients With Severe Mental Disorders

NCT07005245

Sponsor

Peking University

Status

Completed

Last Update Posted

Jun 5, 2025Actual

Enrollment

77,145Actual

Phase

Not provided

Conditions

Schizophrenia and Schizoaffective Disorder
Bipolar Disorder (BD)

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 7, 2021Actual

Primary Completion Date

Nov 30, 2022Actual

Completion Date

Nov 30, 2022Actual

First Submitted Date

May 19, 2025

First Submission Date that Met QC Criteria

Jun 2, 2025

First Posted Date

Jun 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 2, 2025

Last Update Posted Date

Jun 5, 2025Actual

Description Module

Brief Summary

Severe mental disorders represent a major public health concern, imposing substantial disease burden and adversely affecting multiple dimensions of patients' lives, while also creating intergenerational impacts on their offspring and families. Existing evidence suggests that children of affected patients demonstrate elevated vulnerability to various physical and psychological challenges during developmental stages.

Currently, China lacks systematic data regarding reproductive patterns and child-rearing practices among patients with severe mental disorders. To address this knowledge gap, investigators are conducting a multicenter epidemiological survey across ten representative cities and regions nationwide. This study aims to comprehensively examine the reproductive history, child-rearing circumstances, and family socioeconomic status of this population. The findings will establish a crucial foundation for subsequent analytical epidemiological investigations and intervention studies, while informing evidence-based mental health policy formulation.

The study population consists of registered patients (aged 18-59 years) in the national severe mental disorder management system who meet diagnostic criteria for: schizophrenia, bipolar disorder, paranoid personality disorder, schizoaffective disorder, epilepsy-induced mental disorders, or intellectual disability-associated mental disorders. Eligible participants must have documented childbirth history (including miscarriage, preterm, and term deliveries).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

77,145Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Participants' fertility data		Baseline

Secondary Outcomes

Measure	Description	Time Frame
Somatic/psychiatric morbidity history in participants' offspring		Baseline

Other Outcomes

Measure	Description	Time Frame
Participants' demographics, their offspring's education level, and family caregiving situation		Baseline

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who meet the diagnostic criteria for schizophrenia, bipolar disorder, paranoid personality disorder, schizoaffective disorder, mental disorders caused by epilepsy, or mental disorders associated with intellectual disabilities, and are registered in the management system for severe mental disorders
Aged 18-60 years
Patients who had a history of childbirth (childbirth history includes miscarriage, preterm birth, and full-term birth).

Exclusion Criteria:

Do not agree to participate in the survey.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Peking University Sixth Hospital, 51 Huayuan North Road, Haidian District, Beijing.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Sixth Hospital		Beijing	Haidian District	100083	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41362421	Derived	Sheng Z, Zhou T, Du C, Wu T, Wen L, Yang X, Chen W, Ma X, Deng H, Ge L, Zhang C, Hong X, He R, Du X, Zhu L, Xiang H, Chen S, Liu J, Ding Y, Liang G, Pan Y, Ji S, Chang Z, Yuan N, Chen W, Lv X, Ma H, Guan L, Yu X. Sex-differences in the intergenerational transmission of mental disorders among schizophrenia probands: familial risk and protective factors in a population-based study. Lancet Reg Health West Pac. 2025 Nov 20;65:101750. doi: 10.1016/j.lanwpc.2025.101750. eCollection 2025 Dec.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jan 20, 2021	May 29, 2025	Prot_SAP_000.pdf
ICF	No	No	Yes	Informed Consent Form	Jan 20, 2021	May 29, 2025	ICF_001.pdf

ID	Term
D012559	Schizophrenia
D011618	Psychotic Disorders
D001714	Bipolar Disorder

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D000068105	Bipolar and Related Disorders
D019964	Mood Disorders