EUCTR2010-020579-21-IT进行中（未招募）不适用
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
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- ASTRAZENECA
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
相似试验
进行中（未招募）
不适用
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 SchizophreniaMedDRA version: 13.1Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disordersSchizophreniaEUCTR2010-020579-21-DEAstraZeneca AB100
进行中（未招募）
不适用
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 SchizophreniaMedDRA version: 12.1Level: LLTClassification code 10039626Term: SchizophreniaSchizophreniaEUCTR2010-020579-21-ATAstraZeneca AB100
进行中（未招募）
不适用
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 SchizophreniaMedDRA version: 12.1Level: LLTClassification code 10039626Term: SchizophreniaSchizophreniaEUCTR2010-020579-21-DKAstraZeneca AB100
未知
4 期
A Phase IV, Multi-centre, Randomised, Double-Blind Study to Evaluate the Efficacy and Safety of NK- 104 versus Atorvastatin in Chinese Patients with HypercholesterolaemiaJPRN-jRCT2080221598Kowa Co., Ltd.480
进行中（未招募）
1 期
Balneum Plus cream for the Treatment of Itching in Kidney DiseaseEUCTR2014-005594-36-GBPortsmouth Hospitals NHS Trust58