EUCTR2010-024632-42-BE进行中（未招募）1 期
Y2216684 compared to Placebo as Adjunctive Therapy to SSRI in the Prevention of Symptom Re-emergence in Major Depressive Disorder - LNB
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,045
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
- •Clinical diagnosis of Major Depressive Disorder (MDD).
- •Using a reliable method of birth control.
- •Are taking an SSRI approved for MDD treatment within the patient's country and the SSRI prescribed, including dose, should be consistent with labeling guidelines within the participating country.
- •Have a partial response to SSRI treatment.
- •Meet inclusion scores on pre-defined psychiatric scales to assess diagnosis of depression, disease severity, and response to SSRI treatment.
- •Reliable and able to keep all scheduled appointments.
- •Have had at least 1 previous episode of MDD prior to the current episode within the past 5 years.
- •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 1840
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 205
排除标准
- •Have had or currently have any additional ongoing Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) Axis 1 condition other than major depression within 1 year of screening.
- •Have had any anxiety disorder that was considered a primary diagnosis within the past year (including panic disorder, obsessive-compulsive disorder, post-traumatic stress disorder, generalized anxiety disorder, and social phobia, but excluding specific phobias).
- •Have a current or previous diagnosis of a bipolar disorder, schizophrenia, or other psychotic disorder.
- •Have a history of substance abuse and/or dependence within the past 1 year (drug categories defined by DSMIV-TR), not including caffeine and nicotine.
- •Have an Axis II disorder that, in the judgment of the investigator, would interfere with compliance with protocol.
- •Have any diagnosed medical condition which could be exacerbated by noradrenergic agents including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia, narrow-angle glaucoma, history of urinary hesitation or retention.
- •Use of excluded concomitant or psychotropic medication other than SSRI.
- •Have initiated or discontinued hormone therapy within the previous 3 months prior to enrollment.
- •Have a lifetime history of vagal nerve stimulation (VNS), transcranial magnetic stimulation (TMS), or psychosurgery.
- •Have received electroconvulsive therapy (ECT) in the past year
- •Enrollment in a clinical study for an investigational drug.
- •Serious or unstable medical condition.
- •History of seizure disorders.
- •Have initiated psychotherapy, change in intensity of psychotherapy or other nondrug therapies (such as acupuncture or hypnosis) within 6 weeks prior to enrollment or any time during the study.
- •Patients who, in the opinion of the investigator, are judged to be at serious risk for harm to self or others.
- •Are pregnant or breastfeeding.
研究者
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