Clinical trial NCT01213836: Compare the Effect on Cognitive Functioning of Two Formulations of Seroquel, Seroquel XR and IR in Patients With Stable Schizophrenia
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Stable schizophrenia
cognitive functioning
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-10-04
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 patients with schizophrenia stabilized on a single antipsychotic medication.


Eligibility 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)

Primary outcomes:
measure: Mean for Attentional Standardised Composite Score Based on Performance Scores From the CogState Test Battery Domains Detection (Speed of Processing)and Identification (Attention/Vigilance)
timeFrame: Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.
Secondary outcomes:
measure: Mean Treatment Satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM)
timeFrame: Before taking study drug, end of Period 1 and end of Period 2
measure: Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving
timeFrame: Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.
measure: Mean Overall Sedation as Measured by the Modified Bond-Lader Visual Analogue Scale (VAS) When Administered According to Label
timeFrame: Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.
measure: Mean Overall Sedation as Measured by the Stanford Sleepiness Scale When Administered According to Label
timeFrame: Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period.
measure: Number of Dropouts.
timeFrame: Period 1 and Period 2
measure: 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.
timeFrame: End of Period 1, end of Period 2
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Research Site
city: Middelfart
country: Denmark
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Bochum
country: Germany
facility: Research Site
city: Hamburg
country: Germany
facility: Research Site
city: Munchen
country: Germany
facility: Research Site
city: Rottweil
country: Germany
facility: Research Site
city: Giarre
country: Italy
facility: Research Site
state: CT
city: Genova
country: Italy
facility: Research Site
state: GE
city: Lido Di Camaiore
country: Italy
facility: Research Site
state: LU
city: Barakaldo (vizcaya)
country: Italy
facility: Research Site
state: Pais Vasco
city: Tivoli
country: Italy
facility: Research Site
state: RM
city: Sant'arsenio
country: Italy
facility: Research Site
state: SA
city: Sassari
country: Italy
facility: Research Site
state: SS
city: Borgomanero
country: Italy
facility: Research Site
city: Catania
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
city: Torre Annunziata
country: Italy
facility: Research Site
city: Salamanca
country: Spain
facility: Research Site
state: Castilla Leon
city: Zamora
country: Spain
facility: Research Site
state: Castilla Leon
Study officials:
affiliation: AstraZeneca
name: Eva Dencker Vansvik
role: STUDY_DIRECTOR
References: