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临床试验/EUCTR2007-000051-34-IT
EUCTR2007-000051-34-IT进行中(未招募)不适用

Randomized, open-label, controlled and multicenter trial on a new pattern of Paroxetine up-titration for Panic Disorder. Comparison between two different dose regimens. - ND

ITALFARMACO0 个研究点开始时间: 2007年11月30日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

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.Subjects of both sexes 2.Aged ≥ 18 years 3.Suffering from Panic Disorder with or without agoraphobia, according to DSM IV-TR 4.At least two full panic attacks in the last 2 weeks before the screening visit 5.Having signed Informed Consent prior to initiation of any study procedure
  • 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) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • 1.Other concomitant psychiatric illness 2.Suicidal thinking or behaviours 3.Previous psychosis or bipolar disorder 4.Epilepsy 5.Pregnancy or lactation 6.Substances abuse in the last six months 7.Treatment with other investigational drugs or patient inclusion in other clinical trials 8.Antidepressant or benzodiazepine or other psychiatric therapy 9.Benzodiazepines administration in the last two weeks preceding the randomization visit 10.Hypersensitivity to paroxetine or any of the excipients 11.Concomitant therapy with monoamine oxidase inhibitors (MAOIs), thioridazine or with other drugs which inhibit the hepatic enzyme CYP450 2D6 12.Concomitant therapy with full dosage oral anticoagulants (to reach INR > 2.5) 13.Bleeding diathesis 14.Renal failure (creatinemia > 1.5 mg/dl) 15.Known active gastric or duodenal ulcer 16.Severe liver insufficiency (clinical history and lab) 17.Investigator?s lack of confidence on the patient compliance to fulfill the study requirements, in terms of visits / compliance to treatment

研究者

发起方
ITALFARMACO

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