We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of Anti-Psychotic in GPs Setting (Serenity)

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.
ClinicalTrials.gov Identifier: NCT00543088
Recruitment Status : Completed
First Posted : October 12, 2007
Last Update Posted : April 23, 2009
Sponsor:
Information provided by:
AstraZeneca

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

Condition or disease
Schizophrenia Bipolar Disorder

Study Type : Observational
Estimated Enrollment : 250 participants
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.
Study Start Date : January 2007
Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  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 Outcome Measures :
  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)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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)

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

ClinicalTrials.gov Identifier: NCT00543088     History of Changes
Other Study ID Numbers: SRP-NB-SER-2006/1
First Posted: October 12, 2007    Key Record Dates
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