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Effectiveness of Anti-Psychotic in GPs Setting (Serenity)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00543088
First received: October 11, 2007
Last updated: April 22, 2009
Last verified: April 2009
History of Changes
  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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

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

No publications provided

ClinicalTrials.gov 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
Health Authority: Not require for this study:

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

Additional relevant MeSH terms:
Bipolar Disorder
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Antipsychotic Agents
 Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 19, 2013