NCT00857064

Brief Summary

Non-interventional study aiming to provide data on the subjective effects of antipsychotic medication assessing subjective well-being and global functioning of patients with Schizophrenia under antipsychotic medication. Moreover it aims to assess their adherence to the treatment and will investigate whether there is any correlation of these factors with the clinical condition of these patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Shorter than P25 for all trials

Geographic Reach
1 country

24 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

March 1, 2009

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

December 9, 2010

Status Verified

December 1, 2010

Enrollment Period

7 months

First QC Date

March 3, 2009

Last Update Submit

December 7, 2010

Conditions

Keywords

Schizophreniaantipsychoticssocial functioningsubjective well beingPatients suffering from Schizophrenia

Outcome Measures

Primary Outcomes (2)

  • Assessment of Subjective well being

    Relative score reported in SWBN scale at the visit. No baseline comparison

  • Assessment of functioning

    Relative score reported in GAF scale at the visit. No baseline comparison

Secondary Outcomes (3)

  • Assessment of Compliance to therapy

    Relative score reported in BARS scale at the visit. No baseline comparison

  • Assessment of General Psychopathology

    Relative score reported in PANNS scale at the visit. No baseline comparison

  • Assessment of Clinical Condition

    Relative score reported in CGIS scale at the visit. No baseline comparison

Eligibility Criteria

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

Target Group:Patients suffering from Schizophrenia treated in private practice

You may qualify if:

  • Provision of written informed consent
  • Diagnosis of schizophrenia according to DSM-IV
  • The patient must have been prescribed an atypical antipsychotic for at least 4 weeks before the first study visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Research Site

Agrinio, Greece

Location

Research Site

Alexsandroupoli, Greece

Location

Research Site

Argos, Greece

Location

Research Site

Arta, Greece

Location

Research Site

Athens, Greece

Location

Research Site

Crete, Greece

Location

Research Site

Drama, Greece

Location

Research Site

Edessa, Greece

Location

Research Site

Elefsina, Greece

Location

Research Site

Giannitsá, Greece

Location

Research Site

Ioannina, Greece

Location

Research Site

Karditsa, Greece

Location

Research Site

Katerini, Greece

Location

Research Site

Kavala, Greece

Location

Research Site

Kozani, Greece

Location

Research Site

Larissa, Greece

Location

Research Site

Pátrai, Greece

Location

Research Site

Piraeus, Greece

Location

Research Site

Preveza, Greece

Location

Research Site

Rhodes, Greece

Location

Research Site

Serres, Greece

Location

Research Site

Thebes, Greece

Location

Research Site

Thessaloniki, Greece

Location

Research Site

Volos, Greece

Location

MeSH Terms

Conditions

SchizophreniaSocial Adjustment

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersSocial BehaviorBehavior

Study Officials

  • Errikos Tzempelikos, Dr

    Sismanoglio Hospital, Psychiatric Department, Greece

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 3, 2009

First Posted

March 6, 2009

Study Start

March 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

December 9, 2010

Record last verified: 2010-12

Locations