EUCTR2005-001737-15-BE进行中（未招募）1 期
An open-label, non-comparative, multi-centre, phase II prospective trial to assess the efficacy of Quetiapine fumarate augmentation of selective serotonin reuptake inhibitors (SSRIs) in SSRI-resistant major depressive disorder.
V AstraZeneca SA0 个研究点目标入组 40 人开始时间: 2005年7月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
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
- •For inclusion in the study all of the following criteria must be fulfilled on day 1:
- •1. Male and female patients, aged between 18 and 65 with a major depressive disorder not responding to at least one acute treatment with a SSRI and naïve to any atypical antipsychotic will be considered for entry into the study.
- •2. Provision of informed consent before initiating any study-related procedures
- •3. Female or male aged between 18 and 65 years who can read and write
- •4. Naïve to any atypical antipsychotic
- •5. A diagnosis of major depressive disorder, single or recurrent without psychotic features, according to the DSM-IV-R definition
- •6. Being treated for at least 6 weeks with a daily effective dose of an SSRI e.g. citalopram = 20 mg, escitalopram = 10 mg, fluoxetine = 20 mg, fluvoxamine = 100 mg, paroxetine = 20 mg, sertraline = 50 mg
- •7. MADRS score = 25
- •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. Patients with a history of bipolar I or II disorder as defined by DSM-IV-R
- •2. Diagnosis of psychotic major depression disorder according to the DSM-IV-R criteria
- •3. Substance of alcohol dependence at enrolment (except for caffeine or nicotine dependence) as defined by DSM-IV-R criteria
- •4. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV-R criteria
- •5. No or inadequate response to more than two different SSRIs given at the adequate dose during an adequate period of time
- •6. Use of any of the following CYP450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to fluvoxamine, ketoconazole, itraconazole, fluconazole, erythromycin, clarithromoycin, troleandeomycin, indinavir, nelfinavir, ritonavir and saquinavir
- •7. Use of any of the following CYP450 3A4 inducers in the 14 days preceding the enrolment including but not limited to : phenytoin, carbamazepine, barbiturates, rifampin, St. John’s Wort, and flucocorticoids
- •8. Use of the SSRI fluvoxamine in the 14 days preceding the enrolment
- •9. Medical conditions that would affect absorption, distribution, metabolism or excretion of study treatment
- •10. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using a medically acceptable contraceptive.
- •11. Known or suspected hypersensitivity to the investigational product or excipiens
- •12. Planned in-patient hospitalization during the course of the study.
- •13. Any clinically significant abnormal finding at visit 1, which in the opinion of the investigator, may put the patient at risk because of his/her participation in the study.
- •14. Patients suffering from hyperthyroidism
- •15. In the opinion of the investigator, the patient is likely to be non-compliant with the study visit schedule or with the study procedures (e.g. illiterate, poor compliance, etc.)
- •16. Involvement in the planning and the conduct of the study (applies to both AstraZeneca staff or staff at the investigational site)
- •17. Previous enrolment in the present study.
- •18. Patients who in the opinion of the investigator, pose an imminent risk of suicide or danger to self or others.
研究者
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