Status:
COMPLETED
Compare the Effect on Cognitive Functioning of Two Formulations of Seroquel, Seroquel XR and IR in Patients With Stable Schizophrenia
Lead Sponsor:
AstraZeneca
Conditions:
Schizophrenia
Eligibility:
All Genders
18-50 years
Phase:
PHASE4
Brief Summary
This will be a phase IV 20 -32 day prospective, double blind, double-dummy, randomised crossover study that will evaluate the effect of quetiapine XR and quetiapine IR on cognitive performance in pati...
Eligibility Criteria
Inclusion
- Provision of written informed consent prior to any study specific procedures
- 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
Exclusion
- Diagnosis of any DSM-IV Axis I disorder other than those included in inclusion criteria above within 6 months before randomisation (e.g., alcohol dependence or psychoactive substance dependence not in full remission, concurrent organic mental disorder, or mental retardation \[axis II diagnosis\]) of a degree that may interfere with the patient's ability to co-operate.
- 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)
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01213836
Start Date
November 1 2010
End Date
August 1 2011
Last Update
July 27 2012
Active Locations (20)
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1
Research Site
Vienna, Austria
2
Research Site
Middelfart, Denmark
3
Research Site
Berlin, Germany
4
Research Site
Bochum, Germany