Schizophrenia and Schizoaffective DisorderNCT07005245
Survey on the Reproductive and Child-Rearing Situations of Patients With Severe Mental Disorders
An observational study of Schizophrenia and Schizoaffective Disorder and Bipolar Disorder (BD), run by Peking University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Schizophrenia and Schizoaffective Disorder, Bipolar Disorder (BD)
- How many people
- 77,145 participants
- Where
- 1 siteChina
- Study dates
- 7 Jun 2021to 30 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Peking University Sixth Hospital, 51 Huayuan North Road, Haidian District, Beijing.
Who may be able to join
- 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).
Who cannot join
- Do not agree to participate in the survey.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Demand for Psychological and Social Services Related to COVID-19 Pandemic in Families of Patients With Severe Mental Disorders
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).
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Bipolar Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants' fertility data
Measured: Baseline
Secondary outcomes (1)
Somatic/psychiatric morbidity history in participants' offspring
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2025
- Study start7 Jun 2021
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Schizophrenia and Schizoaffective DisorderStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 77,145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07005245
- Sponsor's protocol ID
- 2021-1-13-7
- Status last verified
- Jan 2021
- First submitted
- 19 May 2025
- Last updated
- 5 Jun 2025
- Results posted
- No
- Individual data sharing
- No
Publications
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.
PubMed 41362421
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Demand for Psychological and Social Services Related to COVID-19 Pandemic in Families of Patients With Severe Mental Disorders
- ClinicalTrials.gov ID
- NCT07005245
- Acronym / sponsor ID
- 2021-1-13-7
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77,145 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 7 Jun 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 5 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Peking University Sixth Hospital, 51 Huayuan North Road, Haidian District, Beijing.
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (1 listed)
- Do not agree to participate in the survey.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Participants' fertility data
Time frame: Baseline
1 secondary outcome
Somatic/psychiatric morbidity history in participants' offspring
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- Derived from this study: PubMed 41362421Sheng 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia and Schizoaffective Disorder and Bipolar Disorder (BD), run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants' fertility data (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07005245, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.