Paternal Psychosis After Baby Born | NCT01011088

Studies
Paternal Psychosis After Baby Born

NCT01011088

Sponsor

Nanjing Medical University

Status

Completed

Last Update Posted

Jun 4, 2010Estimated

Enrollment

387Actual

Phase

Not provided

Conditions

Psychosis

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

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NJFY09331M012	Other Grant/Funding Number	Nanjing Medical University

Status Module

Record Verification Date

Jun 2010

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

Nov 2009

Primary Completion Date

May 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Nov 9, 2009

First Submission Date that Met QC Criteria

Nov 10, 2009

First Posted Date

Nov 11, 2009Estimated

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 3, 2010

Last Update Posted Date

Jun 4, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A large number of studies have investigated the psychological disorders occurred in postpartum women, and found that postpartum psychosis is common in new mothers.

However, the situation of paternal psychological status after they had their first baby is not assessed. The investigators hypothesized that they had a high occurrence of paternal psychosis after first baby born. In addition, different factors might influence its onset and development in new fathers.

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

Not provided

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

387Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Early phase		Psychoses within the first 3 months after baby born
Delayed phase		Psychoses > 3 months to one year after baby born

Interventions

Name	Type	Description	Arm Group Labels	Other Names
	Other	Not any artificial interventions were given	Delayed phase Early phase

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of psychoses		Within the first 90 days and 90 days to 12 months postpartum

Secondary Outcomes

Measure	Description	Time Frame
Economic level before baby born		One year before baby born
Social status before baby born		One year before baby born
Psychological level before baby born

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Men will be the would-be fathers
Chinese

Exclusion Criteria:

Age < 18 years or > 50years
Not willing to participating or completing the whole study at any time

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

49 Years

Standard Ages

Adult

Study Population

Fathers with their first baby born

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
XiaoFeng Shen, MD	Nanjing Medical University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Nanjing Maternity and Child Health Care Hospital		Nanjing	Jiangsu	210004	China

Condition Browse Module

MeSH Terms

ID	Term
D011618	Psychotic Disorders

Ancestor Terms

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided