EUCTR2008-007190-20-BG进行中（未招募）不适用
An International, Multicenter, Double-blind, Randomized, Placebo-controlled, Phase IV Study of the Safety and Efficacy of Lithium versus Placebo as an add on to SEROQUEL XR™ (Quetiapine Fumarate) in Adult Patients with Acute Mania
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
- 350
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 informed consent prior to any study-specific procedures.
- •2.Male and female subjects aged 18 to 65 years, inclusive.
- •3.Documented clinical diagnosis meeting the DSM-IV-TR (American Psychiatric Association 2000) criteria for bipolar I disorder, most recent episode manic (296.4x) or mixed (296.6x).
- •4.YMRS total score =20 and =4 on 2 of 4 core items (irritability, speech, content, disruptive/aggressive behavior) at enrollment (Visit 1) and randomization (Visit 2).
- •5.Subjects must have a CGI-BP =4 (moderately ill) at enrollment (Visit 1) and at randomization (Visit 2).
- •6.Subjects must have experienced =1 manic or mixed episode (other than the current episode) in the past 5 years.
- •7.Female subjects of childbearing potential must have a negative serum pregnancy test at enrollment (Visit 1) and be willing to use a reliable method of birth control, i.e., double-barrier method, oral contraceptive, implant, dermal contraception, long term injectable contraceptive, intrauterine device, or tubal ligation.
- •8.Subjects must be able to understand and comply with the requirements of the study, as judged by the investigator.
- •9.Subjects may be outpatients or inpatients at enrollment (Visit 1), but all subjects must be inpatients when randomized (Visit 2) and remain inpatients until discharged at the discretion of the investigator.
- •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.Subjects must not have another current, major DSM-IV-TR Axis I disorder that is symptomatic or has required treatment within 6 months of enrollment, other than the bipolar disorder under study.
- •2.Subjects with >8 mood episodes during the past 12 months.
- •3.Subjects with a mania-like syndrome that is a physiological consequence of a medical condition, a medication, a treatment, substance abuse, or withdrawal.
- •4.Subjects that are continuously hospitalized for acute bipolar mania for >3 weeks immediately prior to randomization (Visit 2).
- •5.Subject with alcohol or other substance dependence or abuse as defined by DSM IV-TR criteria at enrollment (Visit 1) that is not in sustained full or sustained partial remission (12 months or longer), except caffeine and nicotine dependence. Subjects with a positive urine toxicology screen are not excluded unless they satisfy DSM-IV-TR criteria for abuse or dependence, except that subjects are excluded with a single urine toxicology screen positive for cocaine, heroin, or PCP.
- •6.Subjects who use or need to use, within 2 weeks prior to randomization, drugs that strongly induce or inhibit the hepatic metabolizing cytochrome 3A4 enzymes. Examples of inducers are carbamazepine, phenytoin, barbiturates, rifampin, rigabutin, glucocorticoids, thioridazine, and St. John’s wort. Examples of inhibitors are ketoconazole (except for topical use), itraconazole, fluconazole, erythromycin, clarithromycin, indinavir, nelfinavir, ritonavir, and saquinavir.
- •7.Subjects with evidence of a clinical disorder or clinical finding problematic to the study, as judged by the investigator, such as renal (serum creatinine =1.5 mg/dL) or hepatic impairment (alanine transaminase [ALT] or aspartate transaminase [AST] 3 times the upper limit of normal), significant coronary artery disease, cerebrovascular disease, active viral hepatitis B or chronic active hepatitis C, or Acquired Immunodeficiency Syndrome (AIDS).
- •8.Subject with clinical findings that, in the opinion of the investigator, suggest unstable medical conditions, or that might be negatively affected by the study medication or that would negatively affect the study medication. Examples of unstable conditions are poorly controlled hypertension or unstable angina.
- •9.Subjects with conditions that could affect absorption or metabolism of the investigational product (e.g., malabsorption syndrome, severe liver disease), as judged by the investigator.
- •10.Subjects with current or past diagnosis of stroke or medically documented transient ischemic attacks (TIA).
- •11.Subjects with a history of seizure disorder, except febrile convulsions.
- •12.Subjects using any of the following medications:
- •-Antipsychotic use (other than SEROQUEL) within 7 days prior to randomization (Visit 2).
- •-Antidepressant, anxiolytic, hypnotic, or other psychoactive drugs within 7 days prior to randomization (Visit 2), with the exception of lorazepam (or locally available equivalent approved by the Sponsor), if needed, up to a maximum dose of 6 mg which can be used up to the day prior to randomization.
- •-Mood stabilizers (other than lithium) within 2 days prior to randomization (Visit 2).
- •-Fluoxetine within 28 days prior to randomization (Visit 2).
- •-A depot antipsychotic injection within 1 dosing interval (for the depot) prior to randomization (Visit 2).
- •-Irreversible monoamine oxidase inhibitors (MAOI) within 14 days prior to randomization (Visit 2).
- •-Lithium within 14 days prior to randomiz
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