NCT00523783

Brief Summary

To assess the efficacy of 24-week treatment with quetiapine in patients with schizophrenia or schizoaffective disorder

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2007

Shorter than P25 for all trials

Geographic Reach
1 country

3 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

May 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

October 6, 2008

Status Verified

August 1, 2007

Enrollment Period

6 months

First QC Date

August 29, 2007

Last Update Submit

October 3, 2008

Conditions

SchizophreniaSchizoaffective Disorder

Keywords

SchizophreniaSchizoaffectivequetiapinelong-term efficacyNaturalisticObservational

Eligibility Criteria

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

You may qualify if:

  • The patient and the patient's legal representative (if any) must understand the nature of the study and must have given written consent
  • The patient suffers from schizophrenia or schizoaffective disorder according to DSM-IV-TR
  • The patient is between 18 and 65 years old(extremes included)
  • On the basis of physical and neurological examination, medical history, the patient is, in the investigator's opinion, otherwise healthy
  • If the subject is a female of childbearing potential, she must be not pregnant or breast-feeding and be using a reliable method of contraception. Reliable methods may include abstinence, hormonal contraceptives (eg,oral contraceptives or long-term injectable or implantable hormonal contraceptives), double-barrier methods (eg, condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, and tubal ligation

You may not qualify if:

  • The patients who have known hypersensitivity to quetiapine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

Seoul, Dongdamoon-gu, South Korea

Location

Research Site

Seoul, Kangnam-gu, South Korea

Location

Research Site

Seoul, Songpa-gu, South Korea

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Joon-Woo Bahn

    AstraZeneca Korea

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 29, 2007

First Posted

August 31, 2007

Study Start

May 1, 2007

Primary Completion

November 1, 2007

Study Completion

May 1, 2008

Last Updated

October 6, 2008

Record last verified: 2007-08

Locations

KR(3)