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 - ND
- Conditions
- Stable schizophreniaMedDRA version: 9.1Level: SOCClassification code 10037175MedDRA version: 9.1Level: HLGTClassification code 10039628
- Registration Number
- EUCTR2010-020579-21-IT
- Lead Sponsor
- ASTRAZENECA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
1.Provision of written informed consent prior to any study specific procedures
2.Male and female patients aged ?18 and ? 50 years
3.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
4.Patient hospitalised less than 7 times for schizophrenia
5.PANSS score = 65 at enrolment (Visit 1) and CGI-S = 3, i.e., mildly ill, and the symptoms must be stable for the last 4 weeks before randomisation as judged by the investigator
6.Patients must be able to understand and comply with the requirements of the study, as judged by the investigator
7.Outpatient status at enrolment
8.56 days period (8 weeks) of stable psychiatric status before randomisation
9.Treated with quetiapine IR or quetiapine XR in a dose range between 400-750 mg
10.Dose of quetiapine IR or quetiapine XR unchanged during the last 56 days before randomisation
11.Female patients of child bearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at enrolment and be willing to use a reliable method of birth control, i.e. barrier method, oral contraceptive, implant, dermal contraception, long term injectable contraceptive, intrauterine device, or tubal ligation during the study
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1.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.
2.Patients with substance abuse or dependence as defined by DSM-IV criteria and not in full remission or if previous substance abuse or dependence have caused impaired cognition. A urine drug screen test will be performed at enrolment. The investigator will evaluate the toxicology results along with medical history to determine if the patient meets in DSM-IV criteria for substance abuse. Patients are excluded with a single urine toxicology screen (UTS) positive for cocaine, heroin, or PCP
3.Previous stable use of high dosage of benzodiazepines during one year or more
4.Patients with >2 psychotic episodes with hospitalisation during the past 6 months before randomisation
5.Use of drugs that strongly induce or inhibit the hepatic metabolising cytochrome P450 (CYP) 3A4 enzymes within the 14 days before randomisation. Prohibited inducers: carbamazepine, phenytoin, barbiturates, rifampin, rifabutin, oral glucocorticoids, thioridazine, and St. John’s wort. Prohibited inhibitors: ketoconazole (except for topical use), itraconazole, fluconazole, erythromycin, clarithromycin, indinavir, nelfinavir, ritonavir, fluvoxamine, nefazodone, troleandomycin and saquinavir.
6.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; see Table 6)
7.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)
8.Selective serotonin reuptake inhibitor (SSRI) and serotonin/norephinephrine reuptake inhibitor (SNRI) (permitted if stable dosage, i.e., the dose not changed within 28 days prior to randomisation and no change intended during the conduct of the study, see section 5.6, Table 6)
9.Contraindications as detailed in country-specific prescribing information for quetiapine
10.Impaired vision and/or hearing making cognitive testing difficult, as judged by the investigator
11.History of any malignant disease within the past 2 years before randomisation with the exception of minor superficial skin diseases as judged by the investigator (i.e., basal cell carcinoma and squamous cell carcinoma)
12.Receipt of electroconvulsive therapy (ECT) within 90 days prior to randomisation (Visit 2)
13.Patients who in the investigators opinion will require formalized psychotherapy during the study period, unless psychotherapy has been ongoing for a minimum o
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method