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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00255515
First received: November 17, 2005
Last updated: March 24, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: Quetiapine fumarate
Drug: conventional treatment for schizophrenia
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Social outcome measured by Strauss-Carpenter scale [ Time Frame: change from baseline to last visit and end of CRT ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 85
Study Start Date: September 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
quetiapine fumarate
Drug: Quetiapine fumarate
oral
Other Name: Seroquel
Active Comparator: 2
Conventional treatment for schizophrenia
Drug: conventional treatment for schizophrenia
various standard therapies
Experimental: 3
quetiapine fumarate + Cognitive Remediation Therapy
Drug: Quetiapine fumarate
oral
Other Name: Seroquel

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00255515

Locations
Sweden
Research Site
Eskilstuna, Sweden
Research Site
Göteborg, Sweden
Research Site
Hisingsbacka, Sweden
Research Site
Huddinge, Sweden
Research Site
Jönköping, Sweden
Research Site
Lidingö, Sweden
Research Site
Limhamn, Sweden
Research Site
Lund, Sweden
Research Site
Malmö, Sweden
Research Site
Norsborg, Sweden
Research Site
Nyköping, Sweden
Research Site
Stockholm, Sweden
Research Site
Trollhättan, Sweden
Research Site
Umeå, Sweden
Research Site
Vasteras, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Leif Lindström, Västerås
  More Information

No publications provided

Responsible Party: Birgit Ekholm, MD, Neuroscience, AstraZeneca Sweden
ClinicalTrials.gov Identifier: NCT00255515     History of Changes
Other Study ID Numbers: D1449L00004, SCORE
Study First Received: November 17, 2005
Last Updated: March 24, 2009
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 17, 2014