Seroquel XR in the Long Term Treatment of Schizophrenia

Relapse in Schizophrenia Clinical Trial

— SereNIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01202617
• Other study ID #: NIS-NHU-SER-2010/1
• Status: Completed
• Phase: N/A
• First received: September 14, 2010
• Last updated: October 21, 2011
• Start date: September 2010
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1606
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Relapse in Schizophrenia
• Schizophrenia

Locations

Country	Name	City	State
Hungary	Research Site	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	Eger
Hungary	Research Site	Emod
Hungary	Research Site	ERD
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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients remained relapse free after 6 months of treatment		on the 60th day of treatment	No
Primary	Rate of patients remained relapse free after 6 months of treatment		on the 180th day of treatment	No
Secondary	connection between relapse and affective symptoms		on the 60th day of treatment	No
Secondary	connection between relapse and affective symptoms		180th day of treatment	No