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Completed

NCT Number: NCT00255515

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Eskilstuna, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quetiapine fumarate

Drug

oral

Other names: Seroquel

conventional treatment for schizophrenia

Drug

various standard therapies

Primary outcomes

  1. Social outcome measured by Strauss-Carpenter scale

    Time frame: change from baseline to last visit and end of CRT

Secondary outcomes

  1. Change in PANSS total score

    Time frame: change from baseline to visit 2, from baseline to end of CRT and from baseline to last visit

  2. Change in PANSS positive, negative and general psychopathology symptom subscales

    Time frame: change from baseline to visit 2, from baseline to end of CRT and from baseline to last visit

  3. Change in cognition as measured by a Cognitive Battery of Tests

    Time frame: change from baseline to end of CRT and from baseline to last visit

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Open, Randomised, Parallel, Three Treatment Groups, Multicentre, Phase IV Study - in Real Life - to Compare the Change in Social Outcome of Quetiapine Fumarate (Seroquel®) Combined With Cognitive Remediation Therapy to Conventional Treatment in Patients With Schizophrenia.

Acronym: SCORE

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Nov 21, 2005
Registry last updated
Mar 25, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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