NCT00824031

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2009

Shorter than P25 for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

January 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

September 11, 2009

Status Verified

September 1, 2009

First QC Date

January 15, 2009

Last Update Submit

September 10, 2009

Conditions

Schizophrenia

Keywords

schizophreniamedical mental carecaregiverSapin

Outcome Measures

Primary Outcomes (2)

  • Camberwell's scale of Needs Analysis (CAN)

    Once

  • Caregiver Needs Questionnaire(CNF)

    Once

Secondary Outcomes (1)

  • Health of the Nation Outcome Scales (HoNOS)

    Once

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Research Site

Ferrol, A Coruna, Spain

Location

Research Site

Jerez de la Frontera, Cadiz, Spain

Location

Research Site

Torrejón de Ardoz, Castellon, Spain

Location

Research Site

Avilés, Principality of Asturias, Spain

Location

Research Site

La Plana, Valencia, Spain

Location

Research Site

Bilbao, Vizcaya, Spain

Location

Research Site

Córdoba, Spain

Location

Research Site

Girona, Spain

Location

Research Site

Madrid, Spain

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Manuel Gomez-Beneyto

    University of Valencia

    STUDY CHAIR

  • Alberto Gonzalez

    Hospital Universitario Principe de Asturias

    STUDY CHAIR

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 15, 2009

First Posted

January 16, 2009

Study Start

January 1, 2009

Study Completion

July 1, 2009

Last Updated

September 11, 2009

Record last verified: 2009-09

Locations

ES(9)