Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
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, see Learn About Clinical Studies.

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 February 27, 2015