NCT00234377

Brief Summary

The purpose of this study is to document the clinical benefit of quetiapine (Seroquel) sustained release (SR) after switching from another ongoing antipsychotic treatment, regardless of the reason for the switch. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
550

participants targeted

Target at P75+ for phase_3 schizophrenia

Timeline
Completed

Started Nov 2004

Geographic Reach
4 countries

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2005

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
Last Updated

January 4, 2013

Status Verified

January 1, 2013

First QC Date

October 5, 2005

Last Update Submit

January 3, 2013

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • The proportion of patients who have an improved clinical benefit based on assessment of clinical efficacy in combination with assessment of tolerability

Secondary Outcomes (2)

  • The change from baseline in Clinical Global Impression (CGI)-CB score

  • Change from baseline in Positive and Negative Syndrome Scale (PANSS) total score

Interventions

Seroquel SRDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who in their own and/or in the Investigator's opinion, consider ongoing antipsychotic treatment inadequate, because of insufficient efficacy and/or tolerability.
  • Female patients of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation during the study.
  • Able to understand and comply with the requirements of the study, as judged by the Investigator.

You may not qualify if:

  • Meeting the criteria for any other (than schizophrenia) Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Axis I diagnosis, concomitant organic mental disorder or mental retardation.
  • Substance abuse or dependence as defined by DSM-IV and not in full remission. A urine drug screen test will be performed. The Investigator will evaluate the results along with medical history to determine if the patient meets DSM-IV criteria for substance abuse or dependence.
  • Risk of transmitting human immunodeficiency virus (HIV) or hepatitis B, via blood or other body fluids, as judged by the Investigator.
  • Patients who, in the opinion of the Investigator, pose an imminent risk of suicide or a danger to self or others.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Research Site

Vancouver, British Columbia, Canada

Location

Research Site

Aurora, Ontario, Canada

Location

Research Site

Burlington, Ontario, Canada

Location

Research Site

Mississauga, Ontario, Canada

Location

Research Site

Orléans, Ontario, Canada

Location

Research Site

Toronto, Ontario, Canada

Location

Research Site

Québec, Quebec, Canada

Location

Research Site

Saint-Laurent, Quebec, Canada

Location

Research Site

Sherbrooke, Quebec, Canada

Location

Research Site

Prince Albert, Saskatchewan, Canada

Location

Research Site

Helsinki, Finland

Location

Research Site

Mikkeli, Finland

Location

Research Site

Turku, Finland

Location

Research Site

München, Bavaria, Germany

Location

Research Site

Göttingen, Lower Saxony, Germany

Location

Research Site

Aachen, North Rhine-Westphalia, Germany

Location

Research Site

Saarbrücken, Saarland, Germany

Location

Research Site

Aachen, Germany

Location

Research Site

Göttingen, Germany

Location

Research Site

Halle, Germany

Location

Research Site

Homburg, Germany

Location

Research Site

Jena, Germany

Location

Research Site

München, Germany

Location

Research Site

Budapest, Hungary

Location

Research Site

Debrecen, Hungary

Location

Research Site

Gyula, Hungary

Location

Research Site

Székesfehérvár, Hungary

Location

Related Publications (1)

  • Ganesan S, Agambaram V, Randeree F, Eggens I, Huizar K, Meulien D; Study 147 Investigators. Switching from other antipsychotics to once-daily extended release quetiapine fumarate in patients with schizophrenia. Curr Med Res Opin. 2008 Jan;24(1):21-32. doi: 10.1185/030079908x253384.

    PMID: 18021496DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzothiazepinesThiazepinesThiepinsSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • AstraZeneca CNS Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 5, 2005

First Posted

October 7, 2005

Study Start

November 1, 2004

Study Completion

May 1, 2006

Last Updated

January 4, 2013

Record last verified: 2013-01

Locations

CA(10)DE(10)HU(4)FI(3)