NCT00206115

Brief Summary

The purpose of this 6-week study is to determine whether treatment with Seroquel® Sustained Release (SR) is more effective than placebo in the treatment of acute schizophrenia. 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

93
On Track

Trial Health Score

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

Enrollment
535

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Nov 2004

Shorter than P25 for phase_3

Geographic Reach
8 countries

31 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

November 1, 2004

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

January 4, 2013

Status Verified

January 1, 2013

First QC Date

September 14, 2005

Last Update Submit

January 3, 2013

Conditions

Schizophrenic Disorder

Keywords

Schizophrenic disorder

Outcome Measures

Primary Outcomes (1)

  • The primary outcome variable will be the change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment at Day 42.

Secondary Outcomes (3)

  • Efficacy

  • To demonstrate a higher PANSS response rate

  • To demonstrate superior Clinical Global Impressions (CGI) response

Interventions

Seroquel Sustained Release (SR)DRUG
Seroquel Immediate Release (IR)DRUG
PlaceboDRUG

Eligibility Criteria

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

You may qualify if:

  • To be considered for this study the patients should be aged between 18 to 65 years, need to suffer from schizophrenia and must be willing to participate.

You may not qualify if:

  • Patients that suffer from psychiatric disorders other than schizophrenia including drug abuse and dependence, or medical conditions such as specific kidney, heart or thyroid problems, and patients with a known lack of response to drugs for schizophrenia will not be considered for this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (31)

Research Site

Burgas, Bulgaria

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Research Site

Rousse, Bulgaria

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Sofia, Bulgaria

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Sofia- Novi Iskar, Bulgaria

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Athens, Greece

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Chania, Greece

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Corfu, Greece

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Thessaloniki, Greece

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Chennai, India

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Karnataka, India

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Lucknow, India

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New Delhi, India

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Jakarta, DKI Jakarta, Indonesia

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Bandung, West Java, Indonesia

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Surabaya, Indonesia

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Cebu, Philippines

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Davao City, Philippines

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Mandaluyong, Philippines

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Manila, Philippines

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Pasig, Philippines

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Brasov, Romania

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Bucharest, Romania

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Moscow, Russia

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Saint Petersburg, Russia

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Johannesburg, Gauteng, South Africa

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Medunsa, Pretoria, South Africa

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Bloemfontein, South Africa

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Ga-Rankuwa, South Africa

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Johannesburg, South Africa

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Research Site

Lyttelton Manor, South Africa

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Research Site

Pretoria, South Africa

Location

Related Publications (1)

  • Kahn RS, Schulz SC, Palazov VD, Reyes EB, Brecher M, Svensson O, Andersson HM, Meulien D; Study 132 Investigators. Efficacy and tolerability of once-daily extended release quetiapine fumarate in acute schizophrenia: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2007 Jun;68(6):832-42. doi: 10.4088/jcp.v68n0603.

    PMID: 17592906DERIVED

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 CNS Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 21, 2005

Study Start

November 1, 2004

Study Completion

December 1, 2005

Last Updated

January 4, 2013

Record last verified: 2013-01

Locations

GR(4)BU(4)IN(4)RO(2)ID(3)RU(2)PH(5)ZA(7)