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Compare the Effect on Cognitive Functioning of Two Formulations of Seroquel, Seroquel XR and IR in Patients With Stable Schizophrenia

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Seroquel XR- quetiapine fumarate extended release (Drug); Seroquel IR - quetiapine fumarate (Drug); Placebo matching Seroquel XR (Drug); Placebo matching Seroquel IR (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Eva Dencker Vansvik, Study Director, Affiliation: AstraZeneca

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 patients with schizophrenia stabilized on a single antipsychotic medication.

Clinical Details

Official title: A Phase IV Prospective, Double-blind, Double-dummy, Randomised, Crossover Study to Assess the Impact on Daily Cognitive Functioning of Quetiapine Fumarate Immediate Release (Seroquel IR) Dosed Twice Daily and Quetiapine Fumarate Extended Release (Seroquel XR) Dosed Once Daily in the Evening in Patients With Stable Schizophrenia

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Mean for Attentional Standardised Composite Score Based on Performance Scores From the CogState Test Battery Domains Detection (Speed of Processing)and Identification (Attention/Vigilance)

Secondary outcome:

Mean Treatment Satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM)

Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving

Mean Overall Sedation as Measured by the Modified Bond-Lader Visual Analogue Scale (VAS) When Administered According to Label

Mean Overall Sedation as Measured by the Stanford Sleepiness Scale When Administered According to Label

Number of Dropouts.

Mean Ratio of Morning Plasma Concentration of Quetiapine and Nor-quetiapine for Quetiapine IR and Quetiapine XR, at Steady-state Conditions in the End of Each Treatment Period 1 and 2.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- 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)

Locations and Contacts

Research Site, Wien, Austria

Research Site, Middelfart, Denmark

Research Site, Berlin, Germany

Research Site, Bochum, Germany

Research Site, Hamburg, Germany

Research Site, Munchen, Germany

Research Site, Rottweil, Germany

Research Site, Borgomanero, Italy

Research Site, Catania, Italy

Research Site, Roma, Italy

Research Site, Torre Annunziata, Italy

Research Site, Giarre, CT, Italy

Research Site, Salamanca, Castilla Leon, Spain

Research Site, Zamora, Castilla Leon, Spain

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

Additional Information

Starting date: November 2010
Last updated: June 21, 2012

Page last updated: August 23, 2015

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