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Effectiveness of Anti-Psychotic in GPs Setting (Serenity)

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: October 11, 2007
Last updated: April 22, 2009
Last verified: April 2009
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

Schizophrenia Bipolar Disorder

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: SERENITY: Evaluating the Effectiveness of Atypical Antipsychotics in the Community - a Prospective, Multicentre, Observational Study to Evaluate the Impact on Quality of Life of GP-Bases Management of Antipsychotic Treatment in Belgium.

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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)

Estimated Enrollment: 250
Study Start Date: January 2007
Study Completion Date: June 2008

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients diagnosed with Schizophrenia or Bipolar Disorder (currently in a manic episode)
  Contacts and Locations
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Please refer to this study by its identifier: NCT00543088

  Show 57 Study Locations
Sponsors and Collaborators
Principal Investigator: Pitchot W Pr ULg
  More Information Identifier: NCT00543088     History of Changes
Other Study ID Numbers: SRP-NB-SER-2006/1
Study First Received: October 11, 2007
Last Updated: April 22, 2009

Keywords provided by AstraZeneca:
Bipolar Disorder
manic episode
atypical antipsychotic
Schizophrenia or Bipolar Disorder (currently in a manic episode)

Additional relevant MeSH terms:
Bipolar Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Bipolar and Related Disorders
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs processed this record on September 21, 2017