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Immediate Release (IR) to Sustained Release (SR) Switching Study: Study of Switching From IR Seroquel to SR Seroquel in Outpatients With Schizophrenia

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00206128
First received: September 13, 2005
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to determine that the efficacy of the sustained release (SR) formulation of quetiapine (Seroquel) is not inferior to the immediate release (IR) formulation.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Condition Intervention Phase
Schizophrenia
 Drug: Seroquel SR
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 6-week Multicenter, Double-blind, Randomized, Parallel-group, Phase 3 Study to Evaluate the Feasibility of Switching From Immediate-release Quetiapine Fumarate (SEROQUEL) to Sustained-release Quetiapine Fumarate in Outpatients With Schizophrenia (Abbreviated)

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • The proportion of patients who discontinue study treatment due to lack of efficacy or whose positive and negative syndrome scale (PANSS) total score increases 20% or more [ Time Frame: from randomisation to any visit ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change in PANSS total score [ Time Frame: from randomization to week 6 ] [ Designated as safety issue: No ]
  • The change in PANSS positive, negative and general psychopathology symptoms subscale scores respectively [ Time Frame: from randomization to week 6 ] [ Designated as safety issue: No ]
  • The proportion of patients with a Clinical Global Impressions - Improvement (CGI-I) score greater than or equal to 4 [ Time Frame: at week 6 ] [ Designated as safety issue: No ]

Enrollment: 454
Study Start Date: November 2004
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A stable dose of quetiapine IR between 300 and 800 mg/day within 4 weeks prior to the enrolment visit (Visit 1) as judged by the investigator.
  • 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.

Exclusion Criteria:

  • 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.
  • Patients with 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00206128

  Show 69 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Seroquel Medical Science Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00206128     History of Changes
Other Study ID Numbers: D1444C00146
Study First Received: September 13, 2005
Last Updated: January 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AstraZeneca:
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 22, 2013