Study of Mental Care in Spain | NCT00824031

Studies
Study of Mental Care in Spain

NCT00824031

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Sep 11, 2009Estimated

Enrollment

76Actual

Phase

Not provided

Conditions

Schizophrenia

Interventions

Not provided

Countries

Spain

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

Status Module

Record Verification Date

Sep 2009

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

Jan 2009

Primary Completion Date

Not provided

Completion Date

Jul 2009Actual

First Submitted Date

Jan 15, 2009

First Submission Date that Met QC Criteria

Jan 15, 2009

First Posted Date

Jan 16, 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

Sep 10, 2009

Last Update Posted Date

Sep 11, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

Non-interventional, multicenter, cross-sectional study to evaluate the mental care received by schizophrenic patients and their caregivers in Spain irrespective of the drug prescribed.

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

76Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Camberwell's scale of Needs Analysis (CAN)		Once
Caregiver Needs Questionnaire(CNF)		Once

Secondary Outcomes

Measure	Description	Time Frame
Health of the Nation Outcome Scales (HoNOS)		Once

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Schizophrenia (DSM-IV criteria)
Attended to the mental care units for the first time in 2006

Exclusion Criteria:

Participation in another clinical trial
Other criteria that according to the medical criteria make difficult the normal development of the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient aged 18-year old or older who has been diagnosed as schizophrenia

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Manuel Gomez-Beneyto	University of Valencia	Study Chair
Alberto Gonzalez	Hospital Universitario Principe de Asturias	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Ferrol	A Coruna		Spain
Research Site

Condition Browse Module

MeSH Terms

ID	Term
D012559	Schizophrenia

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided