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

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ClinicalTrials.gov Identifier: NCT01202617
Recruitment Status : Completed
First Posted : September 16, 2010
Last Update Posted : October 24, 2011
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease
Relapse in Schizophrenia

Study Design

Study Type : Observational
Actual Enrollment : 1606 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Seroquel XR in the Long Term Treatment of Schizophrenia Focus on Affective Symptoms
Study Start Date : September 2010
Primary Completion Date : October 2011
Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Rate of patients remained relapse free after 6 months of treatment [ Time Frame: on the 60th day of treatment ]
  2. Rate of patients remained relapse free after 6 months of treatment [ Time Frame: on the 180th day of treatment ]

Secondary Outcome Measures :
  1. connection between relapse and affective symptoms [ Time Frame: on the 60th day of treatment ]
  2. connection between relapse and affective symptoms [ Time Frame: 180th day of treatment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Psychiatric outpatients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202617


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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01202617     History of Changes
Other Study ID Numbers: NIS-NHU-SER-2010/1
First Posted: September 16, 2010    Key Record Dates
Last Update Posted: October 24, 2011
Last Verified: October 2011

Keywords provided by AstraZeneca:
Seroquel XR
schizophrenia
relapse prevention

Additional relevant MeSH terms:
Schizophrenia
Recurrence
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Disease Attributes
Pathologic Processes
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs