Schizophrenia Clinical Trial
— eXtRaOfficial 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
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.
Status | Completed |
Enrollment | 75 |
Est. completion date | August 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Research Site | Wien | |
Denmark | Research Site | Middelfart | |
Germany | Research Site | Berlin | |
Germany | Research Site | Bochum | |
Germany | Research Site | Hamburg | |
Germany | Research Site | Munchen | |
Germany | Research Site | Rottweil | |
Italy | Research Site | Barakaldo (vizcaya) | Pais Vasco |
Italy | Research Site | Borgomanero | |
Italy | Research Site | Catania | |
Italy | Research Site | Genova | GE |
Italy | Research Site | Giarre | CT |
Italy | Research Site | Lido Di Camaiore | LU |
Italy | Research Site | Roma | |
Italy | Research Site | Sant'arsenio | SA |
Italy | Research Site | Sassari | SS |
Italy | Research Site | Tivoli | RM |
Italy | Research Site | Torre Annunziata | |
Spain | Research Site | Salamanca | Castilla Leon |
Spain | Research Site | Zamora | Castilla Leon |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Austria, Denmark, Germany, Italy, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean for Attentional Standardised Composite Score Based on Performance Scores From the CogState Test Battery Domains Detection (Speed of Processing)and Identification (Attention/Vigilance) | Attentional standardised composite score: Standardised speed of performance score. Higher Score=better performance. Score range minus infinity to plus infinity. Measured at baseline (before study drug administration) and in Period 1 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. (Last test day not earlier than after 10 days of randomised)and in Period 2 at 3 visits,(post 1),(post 2),(post 3), in a 5-day (maximum 8 day) period. Last test day not earlier than after 10 days of crossover treatment. | 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. | No |
Secondary | Mean Treatment Satisfaction for Treatment Satisfaction Questionnaire of Medication (TSQM) | TSQM is a 14-item questionnaire with 4 sub-scales: effectiveness of the medication; treatment side effects; convenience of the medication; global satisfaction with the medication. Scale range 0-100 for each sub-scale, higher=greater satisfaction/milder side effects/greater convenience/greater overall satisfaction. There are 2 measurement, (after the start of taking study drug) one at end of period 1 and one at end of period 2. That is one measurement per patient per treatment. The mean of all the patients is presented, one mean value per treatment group. |
Before taking study drug, end of Period 1 and end of Period 2 | No |
Secondary | Mean Daytime Cognitive Performance Using CogState: - Working Memory - Verbal Learning) -Reasoning and Problem Solving | International Shopping List Task (ISLT): measures reasoning and problem solving. Min=minus infinity, max=plus infinity, higher score=better performance. Groton Maze Learning Test (GMLT): measures reasoning and problem solving. Min=minus infinity, max=plus infinity, lower score=better performance. Lower=better performance. One Back memory task (ONB: measures working memory, min=minus infinity, max=plus infinity, lower score=better performance. | 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. | No |
Secondary | Mean Overall Sedation as Measured by the Modified Bond-Lader Visual Analogue Scale (VAS) When Administered According to Label | The modified Bond-Lader VAS: The degree of sedation was marked by the patient on a 100 mm VAS ranging between Alert (=0 mm) and Drowsy (=100 mm). The marked length in millimetres. There are 3 assessments made in each period (post 1, 2 and 3 for each period). That is three measurements per patient per treatment. The mean is an overall mean of all the recordings in all patients, one mean value per treatment group. |
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. | No |
Secondary | Mean Overall Sedation as Measured by the Stanford Sleepiness Scale When Administered According to Label | Stanford Sleepiness Scale: The sleepiness was assessed by the patient on a 7 item rating scale ranging from 1 (Feeling active and vital) to 7 (Almost in reverie). There are 3 assessments made in each period (post 1, 2 and 3 for each period). That is three measurements per patient per treatment. The mean is an overall mean of all the recordings in all patients, one mean value per treatment group. |
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. | No |
Secondary | Number of Dropouts. | The number of patients who dropped out was counted. | Period 1 and Period 2 | No |
Secondary | 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. | The ratio was derived as individual plasma concentration of quetiapine divided by the plasma concentration of nor-quetiapine. The mean ratio was derived for each treatment, XR and IR, respectively. | End of Period 1, end of Period 2 | No |
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