Seroquel XR in the Long Term Treatment of Schizophrenia (SereNIS)

October 21, 2011 updated by: AstraZeneca

Seroquel XR in the Long Term Treatment of Schizophrenia Focus on Affective Symptoms

The purpose of the study is to determine whether the Seroquel XR treatment for 6 months improves the relapse prevention in schizophrenic outpatients

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1606

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Baja, Hungary
        • Research Site
      • Balassagyarmat, Hungary
        • Research Site
      • Barcs, Hungary
        • Research Site
      • Berettyoujfalu, Hungary
        • Research Site
      • Budapest, Hungary
        • Research Site
      • Cegled, Hungary
        • Research Site
      • Csongrad, Hungary
        • Research Site
      • Debrecen, Hungary
        • Research Site
      • Dombovar, Hungary
        • Research Site
      • Dunaujvaros, Hungary
        • Research Site
      • ERD, Hungary
        • Research Site
      • Eger, Hungary
        • Research Site
      • Emod, Hungary
        • Research Site
      • Esztergom, Hungary
        • Research Site
      • Godollo, Hungary
        • Research Site
      • Gyongyos, Hungary
        • Research Site
      • Gyor, Hungary
        • Research Site
      • Gyula, Hungary
        • Research Site
      • Hajdusamson-Martinka, Hungary
        • Research Site
      • Hajduszoboszlo, Hungary
        • Research Site
      • Heves, Hungary
        • Research Site
      • Janoshalma, Hungary
        • Research Site
      • Jaszbereny, Hungary
        • Research Site
      • Kalocsa, Hungary
        • Research Site
      • Karcag, Hungary
        • Research Site
      • Kecskemet, Hungary
        • Research Site
      • Kerepestarcsa, Hungary
        • Research Site
      • Ketegyhaza, Hungary
        • Research Site
      • Kiskunhalas, Hungary
        • Research Site
      • Kiskunmajsa, Hungary
        • Research Site
      • Kistokaj, Hungary
        • Research Site
      • Komarom, Hungary
        • Research Site
      • Kozarmisleny, Hungary
        • Research Site
      • Miskolc, Hungary
        • Research Site
      • Nagyatad, Hungary
        • Research Site
      • Nagykallo, Hungary
        • Research Site
      • Nagykanizsa, Hungary
        • Research Site
      • Nagykoros, Hungary
        • Research Site
      • Ny�regyhaza, Hungary
        • Research Site
      • Pecs, Hungary
        • Research Site
      • Pomaz, Hungary
        • Research Site
      • Salgotarjan, Hungary
        • Research Site
      • Satoraljaujhely, Hungary
        • Research Site
      • Soltvadkert, Hungary
        • Research Site
      • Sopron, Hungary
        • Research Site
      • Szeged, Hungary
        • Research Site
      • Szeghalom, Hungary
        • Research Site
      • Szekesfehervar, Hungary
        • Research Site
      • Szekszard, Hungary
        • Research Site
      • Szentendre, Hungary
        • Research Site
      • Szentes, Hungary
        • Research Site
      • Szigetszentmiklos, Hungary
        • Research Site
      • Szigetvar, Hungary
        • Research Site
      • Szolnok, Hungary
        • Research Site
      • Szombathely, Hungary
        • Research Site
      • Tata, Hungary
        • Research Site
      • Tatabanya, Hungary
        • Research Site
      • Toszeg, Hungary
        • Research Site
      • Vac, Hungary
        • Research Site
      • Veszprem, Hungary
        • Research Site
      • Zalegerszeg, Hungary
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Psychiatric outpatients

Description

Inclusion Criteria:

  • schizophrenic outpatients on at least 600 mg Seroquel XR treatment for at least 1 month

Exclusion Criteria:

  • Severe cerebro- and cardiovascular disease, severe hepatic impairment, gravidity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Schizophrenic outpatients between 18 & 70 years of age

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of patients remained relapse free after 6 months of treatment
Time Frame: on the 60th day of treatment
on the 60th day of treatment
Rate of patients remained relapse free after 6 months of treatment
Time Frame: on the 180th day of treatment
on the 180th day of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
connection between relapse and affective symptoms
Time Frame: on the 60th day of treatment
on the 60th day of treatment
connection between relapse and affective symptoms
Time Frame: 180th day of treatment
180th day of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Attila Németh, National Psychiatric Centre
  • Study Chair: Lilla Szabo, AstraZeneca
  • Study Director: Alexandra Henringh, AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

September 14, 2010

First Submitted That Met QC Criteria

September 14, 2010

First Posted (Estimate)

September 16, 2010

Study Record Updates

Last Update Posted (Estimate)

October 24, 2011

Last Update Submitted That Met QC Criteria

October 21, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIS-NHU-SER-2010/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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