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

This study has been completed.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: September 14, 2010
Last updated: October 21, 2011
Last verified: October 2011

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

Relapse in Schizophrenia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Seroquel XR in the Long Term Treatment of Schizophrenia Focus on Affective Symptoms

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Rate of patients remained relapse free after 6 months of treatment [ Time Frame: on the 60th day of treatment ] [ Designated as safety issue: No ]
  • Rate of patients remained relapse free after 6 months of treatment [ Time Frame: on the 180th day of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • connection between relapse and affective symptoms [ Time Frame: on the 60th day of treatment ] [ Designated as safety issue: No ]
  • connection between relapse and affective symptoms [ Time Frame: 180th day of treatment ] [ Designated as safety issue: No ]

Enrollment: 1606
Study Start Date: September 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Schizophrenic outpatients between 18 & 70 years of age


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Psychiatric outpatients


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01202617

  Show 61 Study Locations
Sponsors and Collaborators
Principal Investigator: Attila Nemeth National Psychiatric Centre
Study Chair: Lilla Szabo AstraZeneca
Study Director: Alexandra Henringh AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca Identifier: NCT01202617     History of Changes
Other Study ID Numbers: NIS-NHU-SER-2010/1
Study First Received: September 14, 2010
Last Updated: October 21, 2011
Health Authority: Hungary: National Institute of Pharmacy

Keywords provided by AstraZeneca:
Seroquel XR
relapse prevention

Additional relevant MeSH terms:
Mental Disorders
Schizophrenia and Disorders with Psychotic Features processed this record on October 06, 2015