ISRCTN12638696已完成不适用
Concomitant administration of quetiapine (Seroquel®) in cognitive-behavioural therapy for refractory depression: a 12-week placebo-controlled study
Astra Zeneca Canada Inc.0 个研究点目标入组 32 人开始时间: 2007年10月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Males and females between the ages of 18 and 70.
- •2. Signed an informed consent form and have the capacity to follow the course of the study.
- •3. Diagnostic and Statistical Manual of Mental Disorders - Fourth Edition (DSM-IV) criteria for depression (unipolar) as well as a Hamilton depression rating scale (HAMD, 21 items) score of 20 or greater at screen (day 0) and 18 or over at randomization (day 28).
- •4. A Clinical Global Impression (severity scale) score of 4 or greater.
- •5. Patients will be required to have a diagnosis of refractory major depression as determined by having had;
- •5.1. At least two sequential 8 week treatments with two different classes of antidepressants. For instance, an 8 week treatment with a Selective Serotonin Reuptake Inhibitor (SSRI) + an atypical antidepressant or alternatively, a SSRI + a TriCyclic Antidepressant (TCA) (this latter class would include venlafaxine) or alternatively, a SSRI + a monoamine oxidase inhibitor. All antidepressants would have had to be administered at the following doses:
- •a. Venlafaxine (regular venlafaxine 300 mg/day; venlafaxine 'Extended Release' (venlafaxine XR) 225 mg/day, for at least 3 of the 8 weeks)
- •b. A tricyclic antidepressant (minimum dose of 150 mg/day equivalent of imipramine for 3 of the 8 weeks)
- •c. A SSRI (at a minimum 40 mg/day for fluoxetine, 30 mg/day for paroxetine and citalopram, 150 mg/day of sertraline and 250 mg/day for fluvoxamine for 3 of the 8 weeks)
- •d. Moclobemide (600 mg/day for 3 of the 8 weeks)
- •e. Nefazodone (500 mg/day for 3 of the 8 weeks)
- •f. Bupropion (250 mg/day for 3 of the 8 weeks)
- •g. An irreversible monoamnie oxidase inhibitor (at maximum posology for 3 of the 8 weeks)
排除标准
- •1. Patients who in the investigator's opinion pose a current risk of suicide.
- •2. Women of childbearing potential who are pregnant, planning pregnancy in the next 6 months, breast-feeding, or not using medically adequate means of birth control (abstinence, hormonal treatment, Intrauterine Device [IUD]).
- •3. Any of the following DSM-IV diagnoses: schizophrenia or any other chronic psychotic disorder, personality disorder, panic disorder, generalized anxiety disorder, obsessive-compulsive disorder, somatoform disorder, anorexia nervosa, bulimia, organic mental disorder.
- •4. Definite or suspected substance abuse in the past 12 months.
- •5. Serious or unstable medical illness or any co-existing disease or treatment that in the opinion of the investigator contraindicates the use of study drug.
- •6. Treatment with other psychotropic drugs (prescription or not) other than zopiclone 7.5 mg or temazepam, 15 to 30 mg on a prn (when necessary) basis for insomnia.
- •7. Clinically significant laboratory abnormalities at screen.
- •8. Positive urine screen for drugs of abuse.
- •9. Known or suspected allergies to psychotropic drugs.
- •10. Use of any of the following potent cytochrome P450 inhibitors in the 14 days preceding randomization (Day 1) e.g. ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, tironavir, and saquinavir.
- •11. Use of potent P450 inducers (e.g. phenytoin, carbamazepine, barbiturates, rifampin, glucorticoids) in the 14 days preceding randomization (Day 1).
- •12. Thyroid-stimulating hormone concentration more than 10% above the upper limit of the normal range, regardless of treatment for hypothyroidism or hyhperthyroidism.
研究者
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