ClinicalTrials.gg
CompletedNCT00543088SerenityUpdated Apr 23, 2009

Effectiveness of Anti-Psychotic in GPs Setting

An observational study in Schizophrenia and Bipolar Disorder, sponsored by AstraZeneca. Completed at 57 sites in Belgium. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-04-23.

Sponsored by AstraZeneca · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
250
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Schizophrenia
  • Bipolar Disorder

Keywords

  • Schizophrenia
  • Bipolar Disorder
  • manic episode
  • atypical antipsychotic
  • Schizophrenia or Bipolar Disorder (currently in a manic episode)
03

In context

Schizophrenia

3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.

This study's enrollment of 250 is above the median of 178 across 503 observational studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Patients diagnosed with Schizophrenia or Bipolar Disorder (currently in a manic episode)
05

Study design

Time perspective
Prospective
Enrollment
250 participants
06

What researchers measure

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

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

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

07

Study locations

57 sites
  • Research Site
    Baudour, Belgium
  • Research Site
    Beyne-Heysay, Belgium
  • Research Site
    Bomal, Belgium
  • Research Site
    Bredene, Belgium
  • Research Site
    Brussels, Belgium
  • Research Site
    Esen, Belgium
  • Research Site
    Evere, Belgium
  • Research Site
    Gingelom, Belgium
  • Research Site
    Gouy-lez-Piéton, Belgium
  • Research Site
    Grâce-Hollogne, Belgium
  • Research Site
    Gullegem, Belgium
  • Research Site
    Harelbeke, Belgium
  • Research Site
    Harre, Belgium
  • Research Site
    Hotton, Belgium
  • Research Site
    Houtvenne, Belgium
  • Research Site
    Incourt, Belgium
  • Research Site
    Ixelles-Elsene, Belgium
  • Research Site
    Jalhay, Belgium
  • Research Site
    Jette, Belgium
  • Research Site
    Keumiée, Belgium
  • Research Site
    Lembeke, Belgium
  • Research Site
    Liège, Belgium
  • Research Site
    Limbourg, Belgium
  • Research Site
    Longueville, Belgium
  • Research Site
    Lovendegem, Belgium
  • Research Site
    Malmedy, Belgium
  • Research Site
    Mechelen, Belgium
  • Research Site
    Monceau-sur-Sambre, Belgium
  • Research Site
    Montignies-sur-Sambre, Belgium
  • Research Site
    Moorsel, Belgium
  • Research Site
    Moorseled, Belgium
  • Research Site
    Mouscron, Belgium
  • Research Site
    Namur, Belgium
  • Research Site
    Oostrozebeke, Belgium
  • Research Site
    Ostend, Belgium
  • Research Site
    Oudenaarde, Belgium
  • Research Site
    Poperinge, Belgium
  • Research Site
    Ransart, Belgium
  • Research Site
    Roux, Belgium
  • Research Site
    Ruisbroek, Belgium
  • Research Site
    Schaarbeek, Belgium
  • Research Site
    Spa, Belgium
  • Research Site
    Staden, Belgium
  • Research Site
    Theux, Belgium
  • Research Site
    Tilleur, Belgium
  • Research Site
    Torhout, Belgium
  • Research Site
    Tubize, Belgium
  • Research Site
    Verviers, Belgium
  • Research Site
    Veurne, Belgium
  • Research Site
    Wachtebeke, Belgium
  • Research Site
    Willebroek, Belgium
  • Research Site
    Wilrijk, Belgium
  • Research Site
    Woluwe-St-Lambert, Belgium
  • Research Site
    Zeebrugge, Belgium
  • Research Site
    Zichem, Belgium
  • Research Site
    Zomergem, Belgium
  • Research Site
    Zonnebeke, Belgium
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2007 and a completion of Jun 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 11, 2007
First posted
Oct 12, 2007
Start
Jan 2007
CompletionActual
Jun 2008
Last update
Apr 23, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 23, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00543088
Lead sponsor
AstraZeneca
First posted
Oct 12, 2007
Start date
Jan 2007
Completion
Jun 2008
Last update
Apr 23, 2009

Study contacts

Pitchot W Pr
principal investigator · ULg

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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