Seroquel® Combined With Cognitive Remediation Therapy to Conventional Treatment in Patients With Schizophrenia (SCORE)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00255515
First received: November 17, 2005
Last updated: March 24, 2009
Last verified: March 2009
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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 May 22, 2013