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Effectiveness of Anti-Psychotic in GPs Setting (Serenity)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00543088
First Posted: October 12, 2007
Last Update Posted: April 23, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
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

Condition
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
  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients diagnosed with Schizophrenia or Bipolar Disorder (currently in a manic episode)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00543088


  Show 57 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Pitchot W Pr ULg
  More Information

ClinicalTrials.gov Identifier: NCT00543088     History of Changes
Other Study ID Numbers: SRP-NB-SER-2006/1
First Submitted: October 11, 2007
First Posted: October 12, 2007
Last Update Posted: April 23, 2009
Last Verified: April 2009

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

Additional relevant MeSH terms:
Schizophrenia
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