Compare the Effect on Cognitive Functioning of Two Formulations of Seroquel, Seroquel XR and IR in Patients With Stable Schizophrenia
NCT ID: NCT01213836
Last Updated: 2012-07-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
75 participants
INTERVENTIONAL
2010-11-30
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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First Seroquel XR then Seroquel IR
Patients randomised to Seroquel XR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel IR for 10-16 days
Seroquel XR- quetiapine fumarate extended release
Seroquel XR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient's dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken once a day for 10-16 days.
Seroquel IR - quetiapine fumarate
Seroquel IR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient's dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken twice a day for 10-16 days.
Placebo matching Seroquel XR
Placebo matching Seroquel XR dose 400-700 mg (in tablet form). Dose taken once a day for 10-16 days.
Placebo matching Seroquel IR
Placebo matching Seroquel IR dose 400-700 mg (in tablet form). Dose taken twice a day for 10-16 days.
First Seroquel IR then Seroquel XR
Patients randomised to Seroquel IR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel XR for 10-16 days
Seroquel XR- quetiapine fumarate extended release
Seroquel XR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient's dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken once a day for 10-16 days.
Seroquel IR - quetiapine fumarate
Seroquel IR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient's dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken twice a day for 10-16 days.
Placebo matching Seroquel XR
Placebo matching Seroquel XR dose 400-700 mg (in tablet form). Dose taken once a day for 10-16 days.
Placebo matching Seroquel IR
Placebo matching Seroquel IR dose 400-700 mg (in tablet form). Dose taken twice a day for 10-16 days.
Interventions
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Seroquel XR- quetiapine fumarate extended release
Seroquel XR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient's dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken once a day for 10-16 days.
Seroquel IR - quetiapine fumarate
Seroquel IR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient's dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken twice a day for 10-16 days.
Placebo matching Seroquel XR
Placebo matching Seroquel XR dose 400-700 mg (in tablet form). Dose taken once a day for 10-16 days.
Placebo matching Seroquel IR
Placebo matching Seroquel IR dose 400-700 mg (in tablet form). Dose taken twice a day for 10-16 days.
Eligibility Criteria
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Inclusion Criteria
* Documented clinical diagnosis of schizophrenia, paranoid type, for at least 2 years before randomisation meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV, American Psychiatric Association 2000) criteria of schizophrenia (DSM-IV codes 295.3) confirmed by MINI version 5.0
* Outpatient status at enrolment
* Dose of quetiapine IR or quetiapine XR unchanged during the last 56 days before randomisation
* Previous stable use of high dosage of benzodiazepines during one year or more
* Significant neurological medical history (complicated head trauma as judged by the investigator, epilepsy, meningo-encephalitis)
* Use of the following medication:
* other antipsychotic drug than quetiapine within 28 days prior to randomisation
* a depot antipsychotic injection within two dosing intervals (for the depot) before randomisation (Visit 2)
* other psychoactive drugs within 14 days prior to randomisation (hypnotic or anxiolytic drugs, other than those allowed)
* Use of concomitant therapy likely to affect cognition, Medication prohibited 28 days prior to randomisation: benzodiazepines, amphetamines, reboxitin, atomoxinetine, buspiron, donepezil, duloxetine, galantamine, ginko biloba, memantine, methylphenidate, modafinil, rivastigmine, tacrine, smoking cessation therapy varencicline and any dosage form of nicotine replacement therapy. Medication prohibited 14 days prior to randomisation: irreversible monoamine oxidase inhibitors (MAOI), tricyclic antidepressants (TCA), biperiden, antoicholinergic agents (even if the indications are extra pyramidal symptoms or urinary symptoms)
18 Years
50 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Eva Dencker Vansvik
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Vienna, , Austria
Research Site
Middelfart, , Denmark
Research Site
Berlin, , Germany
Research Site
Bochum, , Germany
Research Site
Hamburg, , Germany
Research Site
München, , Germany
Research Site
Rottweil, , Germany
Research Site
Giarre, CT, Italy
Research Site
Genova, GE, Italy
Research Site
Lido di Camaiore, LU, Italy
Research Site
Barakaldo (vizcaya), Pais Vasco, Italy
Research Site
Tivoli, RM, Italy
Research Site
Sant'Arsenio, SA, Italy
Research Site
Sassari, SS, Italy
Research Site
Borgomanero, , Italy
Research Site
Catania, , Italy
Research Site
Roma, , Italy
Research Site
Torre Annunziata, , Italy
Research Site
Salamanca, Castille and León, Spain
Research Site
Zamora, Castille and León, Spain
Countries
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Other Identifiers
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2010-020579-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D1443L00082
Identifier Type: -
Identifier Source: org_study_id