EUCTR2008-001829-33-FR进行中（未招募）不适用
Duloxetine Versus Placebo in the Long-Term Treatment of Patients with Late-Life Major Depression - HMFA
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
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] Are male or female outpatients at least 65 years of age.
- •[2] Sign the informed consent document.
- •[3] Meet criteria for major depression as defined by the Diagnostic and
- •Statistical Manual of Mental Disorders, Fourth Edition Text Revision
- •(DSM-IV-TR) (American Psychiatric Association. 1994).
- •[4] Have a MADRS total score of at least 20 at Visits 1 and 2.
- •[5] Have a MMSE score of at least 20 at Visit 1.
- •[6] Have had at least one prior episode of MDD as defined by DMS-IVTR.
- •[7] Have a degree of understanding such that the patient can communicate
- •intelligibly with the investigator and study coordinator.
- •[8] Are judged to be reliable and agree to keep all appointments for clinic
- •visits, tests, and procedures required by the protocol (including use of
- •an automated voice response system) and are able to swallow all
- •required medication without opening or crushing.
- •[9] Agree not to participate in any other research trial or study while
- •enrolled in this study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •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
- •[10] Are investigator site personnel directly affiliated with the study, or are
- •immediate family of investigator site personnel directly affiliated with
- •[11] Are employed by Lilly
- •[12] Have received treatment with a drug within the last 30 days that has
- •not received regulatory approval at the time of study entry.
- •[13] Are persons who have previously completed or withdrawn from this
- •study or any other study investigating duloxetine for the treatment of
- •depression.
- •[14] Have any prior history of bipolar disorder, panic disorder, psychosis,
- •schizophrenia, or obsessive-compulsive disorder.
- •[15] Have any current (within the past 12 months) DSM-IV-TR primary Axis I diagnosis other than MDD
- •[16] Have moderate to severe dementia.
- •[17] Have a mental retardation diagnosis or the presence of any other Axis
- •II disorder that, in the judgment of the investigator would interfere
- •with the study compliance.
- •[18] Patients judged clinically to be at serious suicidal risk in the opinion of
- •the investigator.
- •[19] Have a history of substance abuse or dependence within the past 6
- •months (drug categories defined in the DSM-IV), excluding nicotine
- •and caffeine.
- •[20] Have a positive urine drug screen for any substances of abuse.
- •[21] Lack of response of the current episode of major depression to two or
- •more adequate courses of antidepressant therapy with an adequate
- •medication trial defined as a score of > 3 on the Antidepressant
- •Treatment History Form. This tool is provided to sites with the
- •[22] Have a history of a lack of response, at any time, to an adequate trial
- •of duloxetine for the treatment of MDD (defined as treatment with at
- •least 60mg/day of duloxetine for a minimum of 4 weeks).
- •[23] Have a serious medical illness or clinically significant laboratory
- •abnormality that is not stabilized or is anticipated to require
- •hospitalization within 6 months, in the opinion of the investigator.
- •[24] At Visit 1 an ALT, AST, or GGT >3 times upper limit of normal
- •(ULN), based on Study Central Laboratory reference ranges.
- •[25] Have been diagnosed with an acute liver injury or
- •severe cirrhosis
- •[26] Have a prior renal transplant, current renal dialysis, or serum
- •creatinine laboratory value > 1.5 times upper limit of normal (ULN)
- •[27] Are taking any excluded medications within 7 days prior to Visit 2 with the exception of fluoxetine which cannot be taken within 30 days prior to Visit 2.
- •[28] Treatment with a monoamine oxidase inhibitor (MAOI) within 14
- •days prior to Visit 2 or have the potential need to use an MAOI during
- •the study or within 5 days of discontinuation of study drug.
- •[29] Have frequent and/or severe allergic reactions to multiple medications,
- •or known allergic reactions to any of the study drugs.
- •[30] Known hypersensitivity to duloxetine or any of the inactive
- •ingredients.
- •[31] Patients with uncontrolled narrow-angle glaucoma.
- •[32] Have abnormal thyroid-stimulating hormone (TSH) concentration.
- •[33] Have discontinued hormone replacement therapy within the previous 3
- •[34] Have had electroconvulsive therapy (ECT) or transcranial magnetic
- •stimulation (TMS) within the past year.
研究者
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