NCT00228462

Brief Summary

This study is being carried out to see if quetiapine (Seroquel) is effective in preventing patients from a schizophrenic relapse when studied for a long time (1 year) and if so, how it compares with non-active treatment.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
197

participants targeted

Target at P25-P50 for phase_3 schizophrenia

Timeline
Completed

Started Mar 2005

Shorter than P25 for phase_3 schizophrenia

Geographic Reach
2 countries

5 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

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 27, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 29, 2005

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

January 4, 2013

Status Verified

January 1, 2013

First QC Date

September 27, 2005

Last Update Submit

January 3, 2013

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • The primary objective in this study is to demonstrate superior efficacy of quetiapine to placebo by evaluating relapse prevention in long-term use in patients with schizophrenia as measured by the time to first psychiatric relapse up to one year

Secondary Outcomes (1)

  • To demonstrate superiority of quetiapine to placebo by evaluating the risk of relapse in long-term use in patients with schizophrenia by evaluating the one-year relapse rate

Interventions

Seroquel (quetiapine)DRUG

Eligibility Criteria

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

You may qualify if:

  • Stable schizophrenic patients who have provided written informed consent
  • Patients 18 to 65 years old who remain clinically stable after switching to a stable dose of Seroquel (quetiapine).

You may not qualify if:

  • Patients with risk of suicide, other disorders or substance abuse that might interfere with the patient's ability to co-operate,
  • Expected non-compliance to treatment
  • Known diabetes mellitus,
  • Contraindications,
  • Intolerance or non-responsiveness to Seroquel or other safety issues.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Investigative Site

Burgas, Bulgaria

Location

Investigative Site

Radnevo, Bulgaria

Location

Investigative Site

Sofia, Bulgaria

Location

Investigative Site

Bydgoszcz, Poland

Location

Investigative Site

Tuszyn, Poland

Location

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 Seroquel Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 27, 2005

First Posted

September 29, 2005

Study Start

March 1, 2005

Study Completion

April 1, 2006

Last Updated

January 4, 2013

Record last verified: 2013-01

Locations

PL(2)BU(3)