Seroquel® Combined With Cognitive Remediation Therapy to Conventional Treatment in Patients With Schizophrenia

NCT ID: NCT00255515

Last Updated: 2009-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-12-31

Brief Summary

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The purpose of this study is to compare efficacy of quetiapine fumarate combined with Cognitive Remediation Therapy (CRT) to conventional treatment by evaluating change in social outcome in patients with schizophrenia.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

quetiapine fumarate

Group Type EXPERIMENTAL

Quetiapine fumarate

Intervention Type DRUG

oral

2

Conventional treatment for schizophrenia

Group Type ACTIVE_COMPARATOR

conventional treatment for schizophrenia

Intervention Type DRUG

various standard therapies

3

quetiapine fumarate + Cognitive Remediation Therapy

Group Type EXPERIMENTAL

Quetiapine fumarate

Intervention Type DRUG

oral

Interventions

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Quetiapine fumarate

oral

Intervention Type DRUG

conventional treatment for schizophrenia

various standard therapies

Intervention Type DRUG

Other Intervention Names

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Seroquel

Eligibility Criteria

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Inclusion Criteria

* Signed informed consent
* Documented clinical diagnosis of schizophrenia or schizoaffective disorder for at least 2 years.
* Clinically stable and in an outpatient setting before entering the study (visit 1).

Exclusion Criteria

* Use of clozapine and quetiapine within two months prior to visit 1.
* If total points are ≤ 55 Intelligence quotient (IQ) according to score of WAIS-III test at visit 1.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Sweden

Principal Investigators

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Leif Lindström,

Role: PRINCIPAL_INVESTIGATOR

Västerås

Locations

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Research Site

Eskilstuna, , Sweden

Site Status

Research Site

Gothenburg, , Sweden

Site Status

Research Site

Hisingsbacka, , Sweden

Site Status

Research Site

Huddinge, , Sweden

Site Status

Research Site

Jönköping, , Sweden

Site Status

Research Site

Lidingö, , Sweden

Site Status

Research Site

Limhamn, , Sweden

Site Status

Research Site

Lund, , Sweden

Site Status

Research Site

Malmo, , Sweden

Site Status

Research Site

Norsborg, , Sweden

Site Status

Research Site

Nyköping, , Sweden

Site Status

Research Site

Stockholm, , Sweden

Site Status

Research Site

Trollhättan, , Sweden

Site Status

Research Site

Umeå, , Sweden

Site Status

Research Site

Västerås, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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SCORE

Identifier Type: -

Identifier Source: secondary_id

D1449L00004

Identifier Type: -

Identifier Source: org_study_id

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