EUCTR2004-004681-33-LV进行中（未招募）不适用
An International, Multi-centre, Double-blind, Randomised, Parallel-group, Placebo-controlled, Phase III study of the Efficacy and Safety of Quetiapine Fumarate (Seroquel™, single oral 300 mg or 600 mg dose) and Lithium as Monotherapy in Adult Patients with Bipolar Depression for 8 weeks and Quetiapine in Continuation Treatment for 26 up to 52 weeks.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 672
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 before initiation of any study related procedures.
- •2.Male and female patients aged 18 to 65 years, inclusive.
- •3.Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV, American Psychiatric Association, 1994) criteria for bipolar I disorder or bipolar II disorder, most recent episode depressed (296.50-296.54 and 296.89 respectively) confirmed by the amended version of the Structured Clinical Interview for DSM-IV (SCID).
- •4.HAM-D (17-item) total score of ³20 and HAM-D item 1 (depressed mood) score ³2 at Visit 1 (Enrolment) and 2 (Randomisation).
- •5.Be able to understand and comply with the requirements of the study, as judged by the investigator.
- •6.Outpatient status at Visit 1 (Enrolment) and at Visit 2 (Randomisation).
- •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 current DSM-IV Axis I disorder other than bipolar disorder that is symptomatic or requiring treatment within 6 months of enrolment.
- •2.YMRS total >12 at enrolment or randomisation.
- •3.Patients with more than 8 mood episodes during the past 12 months.
- •4.Patients whose current episode of depression exceeds 12 months or is less than 4 weeks from enrolment.
- •5.History of non-response to an adequate treatment (6 weeks) with more than 2 classes of antidepressants during their current episode.
- •6.Substance/alcohol dependence or abuse at enrolment (except dependence in full remission (>12 months) and except caffeine and nicotine dependence) as defined by DSM-IV criteria. Patients with a positive urine toxicology screen will be excluded only if they satisfy the DSM-IV criteria for abuse or dependence. However, a single urine toxicology screen for cocaine, heroin or PCP will lead to exclusion.
- •7.Use of drugs that induce or inhibit the hepatic metabolising cytochrome P450 3A4 enzymes within 2 weeks prior to randomisation or during the randomisation period (see Section 3.7.3, Table 7)
- •8.Use of the following medication:
- •-antipsychotic, mood stabilizer, antidepressant, anxiolytic, hypnotic or other psychoactive drugs within 5 days before randomisation
- •-fluoxetine within 28 days before randomisation
- •-extended release risperidone within 14 days before randomisation
- •-a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
- •-lithium within 7 days before randomisation and/or tapering off started less than 14 days before randomisation
- •9.Patients who in the investigators opinion will require formalised psychotherapy during the study period, unless psychotherapy has been ongoing for a minimum of 3 months prior to randomisation.
- •10.Patients who, in the investigator’s judgment pose a current serious suicidal or homicidal risk, have a HAM-D item 3 score of 3 or greater, or have made a suicide attempt within the past 6 months.
- •11.Pregnancy or lactation. Female patients of childbearing potential must have a negative serum pregnancy test at enrolment and be willing to use a reliable method of birth control, ie, double-barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation, during the study.
- •12.A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
- •-Unstable DM defined as enrolment HbA1c >8.5%.
- •-Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.
- •-Not under care of physician responsible for patient’s DM care.
- •-Physician responsible for patient’s DM care has not indicated that patient’s DM is controlled.
- •-Physician responsible for patient’s DM care has not approved patient’s participation in the study.
- •-Has not been on the same dose of oral hypoglycemic drug(s) and/or diet for the four (4) weeks prior to randomisation. For thiazolidinediones (glitazones) this period should not be less than 8 weeks.
- •-Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks.
- •Note: If a diabetic patient meets one of these criteria the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
- •13.Clinically significant deviation from the reference range in clinical laboratory test results at enrolment as judged by the investiga
研究者
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