NIS to Observe Improvement in Global Assessment of Functioning in Patients With Schizophrenia - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00833456

Purpose

The purpose of the study is to monitor the general functional changes among patients with schizophrenia, treated with atypical antipsychotics dosed once daily for a period of 6 months.The primary study objective is to compare general functioning of patients with schizophrenia treated with Seroquel SR between baseline and the last study visit. The secondary study objectives are to compare general functioning of patients with schizophrenia treated with other atypical antipsychotic medicinal products administered once daily between baseline and the last study visit, monitoring of other indicators of clinical improvement, evaluation of patient compliance and assessment of occurrence of adverse effects

Condition
Schizophrenia

Study Type:	Observational
Study Design:	Case Control, Prospective
Official Title:	Non-interventional Clinical Study to Observe Improvement in Global Assessment of Functioning in Patients With Schizophrenia, Treated With Atypical Antipsychotics

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

To compare improvement in global assessment of functioning (using the GAF scale) between the baseline and the final study visit in the Seroquel SR-treated group. [ Time Frame: three times: 0, 12 and 24 weeks after inclusion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To assess improvement in global assessment of functioning (using the GAF scale) between the baseline and the final study visit in the group of patients treated with other atypical antipsychotics [ Time Frame: three times: 0, 12 and 24 weeks after inclusion ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	400
Study Start Date:	January 2009
Estimated Study Completion Date:	April 2010

Groups/Cohorts
1 Seroquel SR: Patients whose symptoms are controlled with Seroquel SR and started with the therapy up to 1 month before the inclusion
2 Atypical antipsychotics: Patients whose symptoms are controlled with atypical antipsychotic in once daily formulation (excluding Seroquel SR) and started with the therapy up to 1 month before the inclusion

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

patients visiting psychiatrist's practice

Criteria

Inclusion Criteria:

patients have a diagnosis of schizophrenia, as defined by DSM-IV-TR
patients' symptoms are controlled with Seroquel SR started up to 1 month before the inclusion
or patients' symptoms are controlled with other atypical antipsychotic in once daily formulation started up to 1 month before the inclusion

Exclusion Criteria:

patients who are treated with Seroquel SR or other antipsychotic more than 1 month
patients with prescribed antipsychotic combinations
pregnant women or women who are breast-feeding
patients who have been treated with antipsychotics in depot formulations for the last two months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833456

Contacts

Contact: AstraZeneca Slovenia Clinical Study, Information

+ 386 1 51 35 600

gabrijela.dolenc@astrazeneca.com

Locations

Slovenia
Research Site	Recruiting
Begunje, Slovenia
Research Site	Recruiting
Brezice, Slovenia
Research Site	Recruiting
Brezovica pri Ljubljani, Slovenia
Research Site	Recruiting
Idrija, Slovenia
Research Site	Recruiting
Koper, Slovenia
Research Site	Recruiting
Ljubljana, Slovenia
Research Site	Recruiting
Maribor, Slovenia
Research Site	Recruiting
Vojnik, Slovenia
Research Site	Recruiting
Novo Mesto, Slovenia
Research Site	Recruiting
Ormoz, Slovenia
Research Site	Recruiting
Postojna, Slovenia
Research Site	Recruiting
Radenci, Slovenia
Research Site	Recruiting
Sezana, Slovenia
Research Site	Recruiting
Nova Gorica, Slovenia

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Peter Pregelj, MD, PhD

Psihiatricna klinika Ljubljana, Studenec 48, 1260 Ljubljana

More Information

No publications provided

Responsible Party:	AstraZeneca ( Meta Jeras, Mr Ph, Medical and Regulatory Affairs Manager )
Study ID Numbers:	NIS-NSI-SER-2008/1
Study First Received:	January 29, 2009
Last Updated:	July 19, 2009
ClinicalTrials.gov Identifier:	NCT00833456 History of Changes
Health Authority:	Slovenia: Agency for Medicinal Products - Ministry of Health

Keywords provided by AstraZeneca:

schizophrenia
Seroquel SR
atypical antipsychotics
assessment of functioning
GAF scale

Study placed in the following topic categories:

Schizophrenia
Quetiapine
Tranquilizing Agents
Mental Disorders
Psychotropic Drugs

Central Nervous System Depressants
Psychotic Disorders
Antipsychotic Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Schizophrenia
Tranquilizing Agents
Mental Disorders
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on August 28, 2009