Effectiveness of Anti-Psychotic in GPs Setting - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00543088

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

MedlinePlus related topics: Bipolar Disorder Psychotic Disorders Schizophrenia

U.S. FDA Resources

Study Type:	Observational
Study Design:	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.

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

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

Study ID Numbers:	SRP-NB-SER-2006/1
Study First Received:	October 11, 2007
Last Updated:	August 1, 2008
ClinicalTrials.gov Identifier:	NCT00543088
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)

Study placed in the following topic categories:

Schizophrenia
Affective Disorders, Psychotic
Mental Disorders
Bipolar Disorder

Mood Disorders
Quality of Life
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on January 15, 2009