Seroquel® Combined With Cognitive Remediation Therapy to Conventional Treatment in Patients With Schizophrenia - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00255515

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 IV

MedlinePlus related topics: Schizophrenia

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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.

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:	February 2008
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental quetiapine fumarate	Drug: Quetiapine fumarate oral
2: Active Comparator Conventional treatment for schizophrenia	Drug: conventional treatment for schizophrenia various standard therapies
3: Experimental quetiapine fumarate + Cognitive Remediation Therapy	Drug: Quetiapine fumarate oral

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
HUDDINGE, Sweden
Research Site
JÖNKÖPING, Sweden
Research Site
LIMHAMN, Sweden
Research Site
LUND, Sweden
Research Site
MALMÖ, Sweden
Research Site
Hisingsbacka, Sweden
Research Site
STOCKHOLM, Sweden
Research Site
Umeå, Sweden
Research Site
Vasteras, Sweden
Research Site
Lidingö, Sweden
Research Site
Nyköping, Sweden
Research Site
Trollhättan, Sweden
Research Site
NORSBORG, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Leif Lindström,

Västerås

More Information

Responsible Party:	AstraZeneca Sweden ( Birgit Ekholm, MD, Neuroscience )
Study ID Numbers:	D1449L00004, SCORE
Study First Received:	November 17, 2005
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00255515
Health Authority:	Sweden: Medical Products Agency

Study placed in the following topic categories:

Schizophrenia
Quetiapine
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Tranquilizing Agents
Therapeutic Uses
Physiological Effects of Drugs
Psychotropic Drugs

Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009