EUCTR2010-021214-39-LV进行中（未招募）不适用
A Randomized, Placebo-controlled, Double-blind Study of LY2216684 Fixed-dose 12 mg and 18 mg Once Daily as Adjunctive Treatment for Patients With Major Depressive Disorder Who Are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment - Am b
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,893
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] Meet criteria for a primary MDD without psychotic features, as defined by DSM-IV-TR criteria, as determined by clinical assessment and confirmed by the MINI at Visit 1.
- •[2] Are adult male or female outpatients at least 18 years of age or older at the time of informed consent, who provide informed consent by signing the appropriate ICFs. Patients must be competent and able to give their own informed consent.
- •[3] Women of child-bearing potential (not surgically sterilized and between menarche and 1 year after menopause) may participate in the study. Women must test negative for pregnancy at the time of study entry based on a serum pregnancy test and agree to use a reliable method of birth control (for example, use of oral contraceptives; a reliable barrier method of birth control [diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam; intrauterine devices]; partner with vasectomy; or abstinence) during the study and for 1 month following the last dose of investigational product. Men participating agree to use a reliable method of birth control during the study.
- •[4] Are being treated with one of the following SSRIs that have been approved for MDD treatment within the participating country: escitalopram, citalopram, sertraline, fluoxetine, paroxetine, and fluvoxamine; and have been treated with their SSRI at least 6 weeks prior to Visit 2 with at least the last 4 consecutive weeks at a stable optimized dose prior to Visit 2. The SSRI prescribed, including dose, should be consistent with labeling guidelines within the participating country.
- •[5] Meet criteria for partial response at Visit 1 and Visit 2, as defined by investigator’s opinion that the patient has experienced a minimally clinically meaningful improvement with the SSRI treatment. The purpose of this inclusion criterion is to ensure partial responders are enrolled.
- •[6] Have a GRID-HAMD17 total score =16 at Visits 1 and 2.
- •[7] Have =75% improvement on the current SSRI at Visit 1, determined by the MGH-ATRQ-Modified version.
- •[8] Have an education level and a degree of understanding such that the patient can communicate with the site study personnel.
- •[9] Are judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures, including venipuncture, and examinations required by the protocol.
- •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
- •[10] Are investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- •[11] Are Lilly employees.
- •[12] Are currently enrolled in, or discontinued within the last 30 days from, a clinical study involving an investigational drug or device, or participate in the off-label use of a drug or device (other than the investigational product used in this study), or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- •[13] Have previously completed or withdrawn from this study or any other study investigating LY2216684.
- •[14] Have had or currently have any additional ongoing DSM-IV-TR Axis I condition other than major depression that was considered the primary diagnosis within 1 year of Visit 1.
- •[15] Have had any anxiety disorder that was considered a primary diagnosis within the past year (including panic disorder, obsessive-compulsive disorder [OCD], posttraumatic stress disorder [PTSD], generalized anxiety disorder [GAD], and social phobia, but excluding specific phobias).
- •[16] Have a current or previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder.
- •[17] Have a history of substance abuse within the past 1 year (drug categories defined by DSM-IV-TR), and/or substance dependence within the past 1 year, not including caffeine and nicotine.
- •[18] Have an Axis II disorder that, in the judgment of the investigator, would interfere with compliance with the study protocol.
- •[19] Have had a lack of full response of the current depressive episode to 2 or more adequate courses of antidepressant therapy at a clinically appropriate dose for at least 4 weeks, or in the judgment of the investigator, have treatment-resistant depression.
- •[20] Have a lifetime treatment history of vagal nerve stimulation (VNS), transcranial magnetic stimulation (TMS), or psychosurgery.
- •[21] Have received electroconvulsive therapy (ECT) in the past year
- •[22] Are women who are pregnant or breastfeeding.
- •[23] Are judged, in the opinion of the investigator, to be at serious risk for harm to self or others.
- •[24] Have a serious or unstable medical illness, including cardiovascular, hepatic, respiratory, hematologic, endocrinologic, neurologic, or renal disease, or clinically significant laboratory or ECG abnormality. Clinically significant laboratory or ECG abnormalities are those which, in the judgment of the investigator, indicate a serious medical problem or require significant intervention.
- •[25] Have any diagnosed medical condition that could be exacerbated by noradrenergic agents, including unstable hypertension or unstable heart disease, tachycardia or tachyarrhythmia, narrow angle glaucoma, or urinary hesitancy or retention.
- •[26] Have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions.
- •[27] Have a history of any seizure disorder (other than febrile seizures).
- •[28] Have received treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit 1 or have a potential need to use an MAOI within 3 days after discontinuation from the study.
- •[29] Require psychotropic medication other than sedative/hypnotic medication for sleep, as specified in the protocol.
- •[30] Are taking or have received treatment with any excluded medications within 7 days prior to Visit 2.
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