PER-134-08已完成未知
A Randomised, Multi-Centre Study to Compare the Efficacy and Safety of Extended Release Quetiapine Fumarate (Seroquel XR TM) Tablets as Mono-Therapy or in Combination With Lithium in the Treatment of Patients With Acute Bipolar Depression
ASTRAZENECA - PERU,0 个研究点目标入组 0 人开始时间: 2008年12月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
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研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65（—）
- 性别
- All
入选标准
- •Provision of written informed consent before the start of any procedure related to the study. Patients who are deemed unable to provide informed consent may be enrolled if written informed consent has been obtained from the Legally Authorized Representative of the patient.
- •Male and female patients between 18 and 65 years of age, inclusive.
- •Meet the criteria of the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV, American Psychiatric Association 1994) for bipolar disorder I or II, most recent episode of depression (296.5x 296.89x), confirmed by the amended version (by Dr. Michael First) of the Structured Clinical Interview for the DSM-IV (SCID). The duration of the current major episode must be less than one year, but longer than 2 weeks.
- •Hospitalized patients will be enrolled in the study, but the investigator may decide to hospitalize the patient during the washing period.
- •Total HAM-D score (17-item)> 20.
- •HAM-D score item 1 (depressed affect)> 2.
- •Total YMRS <12
- •Patients with conception potential must present a negative urine pregnancy test at the time of enrollment and must use a reliable method of birth control, eg, barrier method, oral contraceptive, implant, dermal contraception, injectable contraceptive Long-term intrauterine device, or tubal ligation during the study.
- •Be able to understand and comply with the requirements of the study, in the opinion of the researcher.
排除标准
- •Patients with a current DSM-IV Axis 1 disorder other than bipolar disorder within the first 6 months of enrollment.
- •History of lack of response to adequate treatment (6 weeks) or more, of 2 classes of antidepressants during your current episode.
- •Patients with prior treatment with quetiapine or lithium will be excluded. The patient should be enrolled if treatment with these medications is at sub therapeutic levels (serum lithium concentration <0.6 mmoI / L or oral dose of quetiapine fumarate <300 mg / day).
- •Substance / alcohol dependence or abuse at the time of enrollment (except dependency on complete remission (> 12 months) and except dependence on caffeine or nicotine) defined by the DSM-IV criteria. Patients with a positive urine toxicological screening will be excluded only if they meet the DSM-IV criteria for abuse or dependence. However, a single urine drug screening for cocaine, heroin or PCP will lead to exclusion.
- •Use of drugs that induce or inhibit the enzymes of the hepatic metabolizing cytochrome P450 3A4 within 14 days prior to randomization eg, inducers: phenytoin, carbamazepine, barbiturates, rifampin, rifabutin, glucocorticoids, thioridazine and St John´s Wort and inhibitors : ketoconazole (except for topical use), itraconazole, fluconazole, erythromycin, clarithromycin, fluvoxamine, nefazodone, troleandomycin, indinavir, nelfinavir, ritonavir, and saquinavir).
- •Electroconvulsive therapy (ECT) within 28 days prior to randomization.
- •Patients who do not have the ability to discontinue all psychoactive medications (excluding benzodiazepines), including antidepressants, antipsychotics and affect stabilizers at least 7 days before randomization and consistent with the pharmacokinetics of the medication
- •Patients who, according to the opinion of the researchers, require the start of psychotherapy during the study period. Note: psychotherapy for a minimum of 3 months can continue.
- •Patients who, in the opinion of the investigator, present a serious current suicide risk or homicidal risk in Visit 1 (HAM-D item 3 score of 3 or greater), or who have presented a suicide attempt within the previous 6 months.
- •Patients with a history of significant cardiac, renal, neurological, cerebrovascular, metabolic or pulmonary disease, congestive heart failure or other disease or clinical finding that is unstable or that, in the opinion of the researcher, is negatively affected by the study medication or that may affect the study medication.
- •Patients who have suffered myocardial infarction 1 year before the visit 1.
- •Patients with clinically significant abnormal laboratory findings at visit 2.
- •Patients with an absolute neutrophil count (ANC) of <1.5x10Vl.
- •Patients with renal impairment (serum creatinine> 1.5 mg / dL) or hepatic impairment (ALT or AST 3 times higher than the normal limit).
- •Patients whose TSH is> 10% above the normal upper limit. Patients maintained with thyroid medication should be euthyroid for a period of at least 3 months before Visit 1.
- •Patients with clinically significant abnormalities in the ECG.
- •Risk of transmission of the human immunodeficiency virus (HIV) hepatitis B, C, through blood or other body fluids, according to the investigator.
- •A patient with Diabetes Mellitus (DM) who meets one of the following criteria: Unstable DM defined as HbAIc (or HgA1c)> 8.5% at the time of enrollment, Hospitalized for DM treatment o
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