PER-053-05已完成未知
A randomized, double-blind, double-simulation, parallel-group, placebo-controlled trial with forced dose adjustment to assess the efficacy and safety of GW679769 and paroxetine in subjects with Major Depressive Disorder
GLAXOSMITHKLINE PERU S.A.,0 个研究点目标入组 0 人开始时间: 2005年11月2日最近更新:
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. Subjects must have the ability to understand the key components of the consent form.
- •2. Outpatient, male or female patients aged 18-64.
- •3. Primary diagnosis of EDM associated with TDM, single or recurrent episode.
- •4. The subjects must, in the opinion of the researcher based on the subject´s history, have met the DSM-IV-TR criteria for their current EDM for at least 8 weeks before the Screening Visit.
- •5. Subjects with a total score on self-assessment with the Carroll Depression Scale - Revised (CDS-R) of> 24 at the Screening Visit and at the Baseline Visit.
- •6. Subjects must have a CGI-Severity of disease score> 4 at the baseline visit.
- •7. Subjects with a history of peptic ulcer disease (PCP) with a known etiology should provide documentation from a gastroenterologist on the etiology of the EUP and that effective treatment with total eradication of ulcers and symptoms was provided.
- •8. Women of reproductive age should commit to the consistent and correct use of an acceptable method of birth control.
排除标准
- •1. Subjects whose EDM symptoms are best explained with another diagnosis.
- •2. Subjects with a history of schizophrenia, schizoaffective disorders or bipolar disorder.
- •3. Subjects that have a positive test for illegal substance use and / or a history of substance abuse or dependence.
- •4. Subjects who currently receive regularly scheduled psychotherapy, plan to initiate psychotherapy during the test or have received regularly scheduled psychotherapy during the 12-week period prior to the Screening Visit.
- •5. Subjects who previously did not respond to adequate courses of pharmacotherapy of two different classes of antidepressants or who did not respond to an adequate course of paroxetine.
- •6. Subjects that in the opinion of the investigator, have serious homicidal or suicidal risk, have attempted suicide within 6 months before screening or have had a homicidal tendency at some time.
- •7. Subjects who received electroconvulsive therapy (ECT) or transcranial magnetic stimulation (TMS) within 6 months before the Screening Visit.
- •8. Subjects with a history of seizure disorders.
- •9. Subjects with unstable medical disorder; or a disorder that is likely to interfere with the action, absorption, distribution, metabolism, or excretion of GW679769, or paroxetine.
- •10. Subjects with a history of myocardial infarction within one year before the Screening Visit.
- •11. Subjects with a laboratory value for screening outside the specified ranges.
- •12. Subjects with laboratory abnormalities considered by the investigator to be clinically significant.
- •13. Subjects that are not euthyroid.
- •14. Subjects with a parameter in electrocardiography (ECG) screening outside the specified ranges.
- •15. Subjects with an ECG finding that the researcher deems clinically significant.
- •16. Subjects with active EUP and / or EUP history of unknown etiology.
- •17. Subjects that probably require the use of the following medications: NSAIDs, COX2 inhibitors.
- •18. Subjects that have been discovered have positive feces for occult blood.
- •19. Subjects known or suspected iron deficiency.
- •20. Women with a positive serum HCG pregnancy test.
- •21. Subjects who have taken other psychoactive drugs in the space of two weeks before.
- •22. Subjects who have taken other drugs metabolised by the cytochrome P450 3A4 route with a narrow therapeutic index within 2 weeks before the baseline visit.
- •23. Subjects who have taken other drugs that are inhibitory
- •potent or moderate or inducers of the cytochrome P450 3A4 route within 2 weeks before the baseline visit.
- •24. Subjects with hypersensitivity or intolerance to NK1 antagonists or SSRIs.
- •25. Subjects who participated in a clinical trial that involved GW679769.
- •26. Subjects currently participating in another clinical trial in which the subject is or will be exposed to a drug or device under investigation.
- •27. Subjects who do not have contact with an adult on a daily basis.
- •28. Subjects taking triptan drugs, the antibiotic linezolid or tryptophan.
- •29. Subjects with a history of myopathy or rhabdomyolysis.
- •30. Subjects who regularly participate in strenuous exercises.
研究者
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