EUCTR2005-003181-41-EE进行中（未招募）不适用
An eight-week, double-blind, placebo-controlled, multicenter study with paroxetine (20 mg q24) as positive control, evaluating the efficacy, safety and tolerability of a fixed dose of SR58611A (350 mg q12) in outpatients with Generalized Anxiety Disorder. - NA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 360
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
- •Out-patients, 18 to 65 years of age.
- •Patients suffering from generalized anxiety disorder (GAD) as defined by Diagnostic and
- •Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria and
- •confirmed by the Mini International Neuropsychiatric Interview (MINI) plus GAD Module.
- •With a total score on the 14-item Hamilton Anxiety Rating Scale (HAM-A) >= 20.
- •Having given voluntarily their written informed consent to participate in the study.
- •Able to comply with the protocol and follow written and verbal instructions.
- •Completion of a minimum of 3 and a maximum of 9 days of treatment in Segment A. Not placebo
- •responders (i.e., improvement <= 20 % on HAM-A total score between V1 and V2).
- •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)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients with a diagnosis of Major Depressive Disorder as defined by DSM-IV-TR within 6 months
- •of study entry.
- •Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) total score of 18 or
- •higher at screening or baseline.
- •Patients having a current score of >5 on the suicidal thoughts item of the MADRS at screening or
- •baseline and/or are assessed to have a moderate to high current risk for suicide according to the
- •Patients with other current anxiety disorder (within 6 months) assessed with the MINI:
- •Agoraphobia, social phobia, Panic disorder, Obsessive compulsive disorder, Post-traumatic
- •stress disorder, acute stress disorder.
- •Patients with a lifetime history according to the MINI of: Bipolar disorders, Psychotic disorders,
- •Antisocial Personality Disorder.
- •Patients with a current history according to the MINI of: Anorexia nervosa or bulimia nervosa in
- •the past 6 months, Alcohol dependence or abuse or substance dependence or abuse in the past
- •12 months except nicotine or caffeine dependence.
- •Patients with a history of non-response to treatment with paroxetine.
- •Hypersensitivity to paroxetine.
- •Patients who have used the following prior to screening: any antipsychotic within 3 months, any
- •antidepressant within 4 weeks, any continuous use of anxiolytic (e.g., benzodiazepines,
- •buspirone) or hypnotic within 2 weeks, any mood-stabilizer (lithium, anticonvulsants) within 4
- •weeks. Treatment with electroconvulsive therapy (ECT) or rapid Transcranial Magnetic
- •Stimulation (rTMS) within 3 months prior to screening.
- •Patients who have initiated, stopped, or changed the frequency or nature of psychotherapy within
- •3 months prior to screening.
- •General and Medical Exclusion criteria :
- •Patients with severe or unstable concomitant medical conditions (cardiovascular, neurologic,
- •gastrointestinal, hepatic, renal, endocrinologic, rheumatologic).
- •History of seizures other than a single childhood febrile seizure.
- •Patients with clinically significant ECG findings at screening.
- •Females who are pregnant or lactating.
- •Patients with positive test for any illicit drug included in the urine drug screen.
- •Participation in a clinical trial of an experimental therapy within 3 months prior to screening.
- •Any subject who has previously participated in a clinical trial with SR58611A.
研究者
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