PER-062-05已完成未知
Phase III, International, Multicenter, Double Blind, Randomized, Parallel Groups, Placebo Controlled Trial of the Efficacy and Safety of Quetiapine Fumarate (Seroquel ™, 300 mg or 600 mg Single Oral Dosage) and Paroxetine as Monotherapy in Patients Adults with Bipolar Depression for 8 weeks and Quetiapine in Continuation Treatment for 26 weeks up to 52 weeks
ASTRAZENECA - PERU,0 个研究点目标入组 0 人开始时间: 2005年11月7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
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Provide written informed consent before initiating any procedure related to the study.
- •2. Male and female patients from 18 to 65 years of age.
- •3. Documented clinical diagnosis for bipolar I disorder or bipolar II disorder.
- •4. A total score> 20 on the HAM-D scale (of 17 items) and a score> 2 on item 1 of the HAM-D scale (depressed mood).
- •5. Be able to understand and comply with the requirements of the study.
- •6. Ambulatory status.
排除标准
- •1. Patients with a current Axis I disorder according to the DSM-IV.
- •2. Total score> 12 on the YMRS scale.
- •3. Patients with more than 8 episodes related to mood during the last 12 months.
- •4. Patients whose current episode of depression exceeds 12 months or is less than 4 weeks from enrollment.
- •5. History of lack of response to adequate treatment with
- •more than 2 kinds of antidepressants during his current episode.
- •6. Dependence or abuse of substances / alcohol.
- •7. Use of drugs that induce or inhibit hepatic enzymes of cytochrome P450 3A4 metabolism within 2 weeks prior to randomization.
- •8. Use of the following medications: a) antipsychotic, mood stabilizer, antidepressant, anxiolytic, hypnotic or other psychoactive dogas within 5 days prior to randomization. b) fluoxetine within 28 days prior to randomization c) risperidone prolonged release within 14 days prior to randomization d) an injection of a depot antipsychotic within a dosing interval e) lithium within 7 days prior to randomization f) irreversible inhibitors of monoamine oxidase within 14 days prior to randomization.
- •9. Patients who will require formalized psychotherapy.
- •10. Patients who present a serious current risk of suicide or homicide, have a score of 3 or more on item 3 of the HAM-D scale, or have made a suicide attempt within the last 6 months.
- •11. Pregnancy or lactation. Female patients of childbearing age should obtain a negative result on the serum pregnancy test at enrollment and should be willing to use a reliable method of birth control.
- •12. A patient with uncontrolled Diabetes Mellitus.
- •13. Clinically important deviation of the reference range in the results of the clinical laboratory analysis.
- •14. Evidence of clinically relevant disease or clinical finding that is unstable.
- •15. Patient with renal impairment or liver failure.
- •16. A concentration of thyroid stimulating hormone (TSH) greater than 10% above the upper limit of the normal range.
- •17. Result of ECG that is considered clinically significant.
- •18. Patients with a history of noncompliance.
- •19. History of idiopathic orthostatic hypotension, or conditions that would predispose patients to hypotension.
- •20. Known history of intolerance or hypersensitivity to quetiapine or paroxetine or to any of the components of the tablets or capsules.
- •21. Lack of known response to quetiapine or paroxetine.
- •22. Contraindications as detailed in the country-specific prescription information for quetiapine or paroxetine.
- •23. Participation in another drug study within 30 days prior to enrollment in this study.
- •24. Participation in the planning and conduct of the study.
- •25. Previous enrollment or randomization of treatment in the present study. Previous participation in this study or in studies D1447C00135 or D1447C00001.
- •26. A score> 12 on the MADRS scale or> 12 on the YMRS scale in Week 8.
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