NCT00779506

Brief Summary

This is an 8-week, multi-centre, Open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients. The eligible patient will be assigned to study treatment with Quetiapine XR on Day 1. 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
96

participants targeted

Target at P50-P75 for phase_4 schizophrenia

Timeline
Completed

Started Nov 2008

Shorter than P25 for phase_4 schizophrenia

Geographic Reach
1 country

7 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

First Submitted

Initial submission to the registry

October 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2008

Completed
8 days until next milestone

Study Start

First participant enrolled

November 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

November 23, 2011

Completed
Last Updated

November 23, 2011

Status Verified

May 1, 2010

Enrollment Period

8 months

First QC Date

October 22, 2008

Results QC Date

May 20, 2010

Last Update Submit

October 19, 2011

Conditions

Schizophrenia

Keywords

Acute schizophreniaPANSS

Outcome Measures

Primary Outcomes (1)

  • The Change in Positive and Negative Syndrome Scale(PANSS)Total Score

    PANSS, a 30-item scale where each symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme), total score is 30 - 210. Description of the reporting Groups: Evaluate the efficacy of Quetiapine XR with daily dose 400 mg - 800 mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline to Day 57 in total score of PANSS using the last observation carried forward (LOCF) method

    From baseline to Day 57

Secondary Outcomes (6)

  • Positive and Negative Syndrome Scale (PANSS) Positive Score

    From baseline to Day 57

  • Positive and Negative Syndrome Scale (PANSS) Negative Score

    From baseline to Day 57

  • Positive and Negative Syndrome Scale (PANSS) General Psychopathology Score

    From baseline to Day 57

  • Clinical Global Impression (CGI) Score

    From baseline to Day 57

  • Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

    From baseline to Day 57

  • +1 more secondary outcomes

Study Arms (1)

Quetiapine Fumarate XR

EXPERIMENTAL

Seroquel XR 400-800mg

Drug: Quetiapine Fumarate XR

Interventions

Quetiapine Fumarate XRDRUG

oral, once daily, flexible dose

Also known as: Seroquel XR
Quetiapine Fumarate XR

Eligibility Criteria

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

You may qualify if:

  • Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
  • PANSS total score of at least 70 at enrolment and at assignment Day 1
  • CGI Severity of Illness score of at least 4 (moderately ill) at enrolment and at assignment Day 1 and with worsening of the patient's condition during the 3 weeks

You may not qualify if:

  • Known intolerance or lack of response to quetiapine fumarate
  • Administration of a depot antipsychotic injection within one dosing interval (for the depot) before assignment
  • Substance or alcohol dependence at enrolment
  • Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Research site

Ansan, Gyeonggi-do, South Korea

Location

Research site

Gwangju, Gyeonggi-do, South Korea

Location

Research site

Bugok, Gyeongsangnam-do, South Korea

Location

Research site

Masan, Gyeongsangnam-do, South Korea

Location

Research site

Incheon, South Korea

Location

Research site

Pusan, South Korea

Location

Research site

Seoul, South Korea

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • YounHoon Kim

    Inje University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2008

First Posted

October 24, 2008

Study Start

November 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

November 23, 2011

Results First Posted

November 23, 2011

Record last verified: 2010-05

Locations

KR(7)