NCT00543088

Brief Summary

Evaluating the effectiveness of atypical antipsychotics in the community - a prospective, multicentre, observational study to evaluate the impact on Quality of Life of GP-based management of antipsychotic treatment in Belgium

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

57 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, 2007

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 11, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 12, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
Last Updated

April 23, 2009

Status Verified

April 1, 2009

First QC Date

October 11, 2007

Last Update Submit

April 22, 2009

Conditions

SchizophreniaBipolar Disorder

Keywords

SchizophreniaBipolar Disordermanic episodeatypical antipsychoticSchizophrenia or Bipolar Disorder (currently in a manic episode)

Outcome Measures

Primary Outcomes (1)

  • to evaluate the patient's functioning, by measuring the Quality of Life. Quality of Life will be assessed by the Q-LES-Q-16 (PRO).

Secondary Outcomes (2)

  • The clinical efficacy & tolerability of atypical antipsychotics as assessed by the Clinical Global Impression(CGI) & Patient Global Impression of Change(PGIC)scores.

  • The wellbeing of the patients taking atypical antipsychotics as assessed by the Sheehan Disability Scale(SDS)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with Schizophrenia or Bipolar Disorder (currently in a manic episode)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (57)

Research Site

Baudour, Belgium

Location

Research Site

Beyne-Heysay, Belgium

Location

Research Site

Bomal, Belgium

Location

Research Site

Bredene, Belgium

Location

Research Site

Brussels, Belgium

Location

Research Site

Esen, Belgium

Location

Research Site

Evere, Belgium

Location

Research Site

Gingelom, Belgium

Location

Research Site

Gouy-lez-Piéton, Belgium

Location

Research Site

Grâce-Hollogne, Belgium

Location

Research Site

Gullegem, Belgium

Location

Research Site

Harelbeke, Belgium

Location

Research Site

Harre, Belgium

Location

Research Site

Hotton, Belgium

Location

Research Site

Houtvenne, Belgium

Location

Research Site

Incourt, Belgium

Location

Research Site

Ixelles-Elsene, Belgium

Location

Research Site

Jalhay, Belgium

Location

Research Site

Jette, Belgium

Location

Research Site

Keumiée, Belgium

Location

Research Site

Lembeke, Belgium

Location

Research Site

Liège, Belgium

Location

Research Site

Limbourg, Belgium

Location

Research Site

Longueville, Belgium

Location

Research Site

Lovendegem, Belgium

Location

Research Site

Malmedy, Belgium

Location

Research Site

Mechelen, Belgium

Location

Research Site

Monceau-sur-Sambre, Belgium

Location

Research Site

Montignies-sur-Sambre, Belgium

Location

Research Site

Moorsel, Belgium

Location

Research Site

Moorseled, Belgium

Location

Research Site

Mouscron, Belgium

Location

Research Site

Namur, Belgium

Location

Research Site

Oostrozebeke, Belgium

Location

Research Site

Ostend, Belgium

Location

Research Site

Oudenaarde, Belgium

Location

Research Site

Poperinge, Belgium

Location

Research Site

Ransart, Belgium

Location

Research Site

Roux, Belgium

Location

Research Site

Ruisbroek, Belgium

Location

Research Site

Schaarbeek, Belgium

Location

Research Site

Spa, Belgium

Location

Research Site

Staden, Belgium

Location

Research Site

Theux, Belgium

Location

Research Site

Tilleur, Belgium

Location

Research Site

Torhout, Belgium

Location

Research Site

Tubize, Belgium

Location

Research Site

Verviers, Belgium

Location

Research Site

Veurne, Belgium

Location

Research Site

Wachtebeke, Belgium

Location

Research Site

Willebroek, Belgium

Location

Research Site

Wilrijk, Belgium

Location

Research Site

Woluwe-St-Lambert, Belgium

Location

Research Site

Zeebrugge, Belgium

Location

Research Site

Zichem, Belgium

Location

Research Site

Zomergem, Belgium

Location

Research Site

Zonnebeke, Belgium

Location

MeSH Terms

Conditions

SchizophreniaBipolar DisorderMania

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Pitchot W Pr

    ULg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 11, 2007

First Posted

October 12, 2007

Study Start

January 1, 2007

Study Completion

June 1, 2008

Last Updated

April 23, 2009

Record last verified: 2009-04

Locations

BE(57)