NCT00304473

Brief Summary

Assess the efficacy of a fast titration of quetiapine to the current titration approved by the regulatory authorities. 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

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_3 schizophrenia

Timeline
Completed

Started Aug 2004

Geographic Reach
1 country

1 active site

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

August 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2006

Completed
12 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
Last Updated

March 25, 2009

Status Verified

March 1, 2009

First QC Date

March 17, 2006

Last Update Submit

March 24, 2009

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Compare the safety and tolerability of a fast titration of quetiapine to the current titration approved by the regulatory authorities.

Secondary Outcomes (1)

  • Assess the efficacy of a fast titration of quetiapine to the current titration approved by the regulatory authorities.

Interventions

Quetiapine fumarateDRUG

Eligibility Criteria

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

You may qualify if:

  • Signed informed consent, at least 18 years old, inpatients with relapse Schizophrenia all subtypes, and with a CGI (Clinical Global Impression) score \>=4.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Site

Taoyuan District, Taiwan

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 Taiwan Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

March 17, 2006

First Posted

March 20, 2006

Study Start

August 1, 2004

Study Completion

April 1, 2006

Last Updated

March 25, 2009

Record last verified: 2009-03

Locations

TW(1)