NCT00749970

Brief Summary

Observational, short-term prospective, multicenter study to assess psychometric properties of the Spanish version of SWN-K scale in patients with schizophrenia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2008

Shorter than P25 for all trials

Geographic Reach
1 country

14 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

July 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

December 10, 2010

Status Verified

December 1, 2010

Enrollment Period

6 months

First QC Date

September 9, 2008

Last Update Submit

December 8, 2010

Conditions

SchizophreniaSchizoaffective DisorderSchizophreniform Disorder

Keywords

schizophreniasubjective well-beingpsychometric validation

Outcome Measures

Primary Outcomes (2)

  • SWN-K

    7 days

  • PANSS

    7 days

Secondary Outcomes (1)

  • CGI-I

    7 days

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 with a diagnosis of schizophrenia, schizoaffective disorder, or shizophreniform disorder

You may qualify if:

  • Patients with a diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder (DSM-IV TR criteria)
  • Stabilized out-patients
  • Under treatment with an oral antipsychotic drug

You may not qualify if:

  • Administration of a depot antipsychotic drug
  • Participation in another clinical trial within 4 weeks prior to enrolment into this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Research Site

Alicante, Spain

Location

Research site

Barcelona, Spain

Location

Research site

Burgos, Spain

Location

Research Site

Córdoba, Spain

Location

Research Site

Granada, Spain

Location

Research site

Madrid, Spain

Location

Research Site

Mallorca, Spain

Location

Research Site

Salamanca, Spain

Location

Research Site

Seville, Spain

Location

Research site

Tarragona, Spain

Location

Research Site

Valencia, Spain

Location

Research Site

Valladolid, Spain

Location

Research Site

Vitoria-Gasteiz, Spain

Location

Research Site

Zaragoza, Spain

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 9, 2008

First Posted

September 10, 2008

Study Start

July 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

December 10, 2010

Record last verified: 2010-12

Locations

ES(14)