EUCTR2008-002857-18-FI进行中（未招募）不适用
A Randomized, Double-Blind Comparison of LY2216684and Placebo and Long Term Treatment with LY2216684in Adult Patients with Major Depressive Disorder
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 478
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
- •Adult men or women at least 18 to 65 years of age at informed
- •consent, who provide informed consent by signing the appropriate
- •ICDs. Patients must be competent and able to give their own
- •informed consent.
- •[2] Meet criteria for MDD as defined by DSM-IV-TR criteria without
- •psychotic features, as determined by clinical assessment and
- •confirmed by the MINI at Visit 1. Have had at least one other major
- •depressive episode prior to the current episode.
- •[3] Women of child-bearing potential (not surgically sterilized and
- •between menarche and 1 year postmenopause) may participate in the
- •study. Women must test negative for pregnancy at the time of
- •enrollment 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.
- •[4] Have a GRID-HAMD17 total score =18 at Visit 1 and Visit 2.
- •[5] Have a CGI-Severity score =4 at Visit 1 and Visit 2.
- •[6] Have an education level and a degree of understanding such that the
- •patient can communicate with the site study personnel.
- •[7] 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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients will be excluded from the study if they meet any of the following criteria:
- •* Have previously completed or withdrawn from this study or any other
- •study investigating LY2216684.
- •* 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.
- •*Have had any anxiety disorder preceding the onset of depression that
- •was considered a primary diagnosis within the past year (including
- •panic disorder, obsessive-compulsive disorder, posttraumatic stress
- •disorder, generalized anxiety disorder, and social phobia, but
- •excluding specific phobias).
- •*Have an Axis II disorder which, in the judgment of the investigator,
- •would interfere with compliance with the study protocol.
- •*Have a current or previous diagnosis of Bipolar I or II Disorder,
- •psychotic depression, schizophrenia, or other psychotic disorder
- •*Women who are pregnant or breast-feeding.
- •*Have had a lack of 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, the patient has treatment-resistant depression.
- •*Patients who, in the opinion of the investigator, are judged to be at
- •serious risk for harm to self or others.
- •*Have any diagnosed medical condition which could be exacerbated by
- •noradrenergic agents including unstable hypertension or unstable heart
- •disease, tachycardia or tachyarrhythmia, narrow angle glaucoma, or
- •urinary hesitancy or retention.
- •*Have received treatment with a monoamine oxidase inhibitor within
- •14 days prior to Visit 1 or have a potential need to use a monoamine
- •oxidase inhibitor within 14 days after discontinuation from the study.
- •*Have received treatment with fluoxetine within 30 days prior to
- •*Have a history of electroconvulsive therapy (ECT), transcranial
- •magnetic stimulation (TMS), or psychosurgery within the last year
- •*Have a history of any seizure disorder (other than febrile seizures).
- •*Require psychotropic medication other than sedative/hypnotic
- •medication for sleep as specified in the protocol.
- •*Have a thyroid stimulating hormone (TSH) level outside the laboratory
- •established reference range. Patients previously diagnosed with
- •hyperthyroidism or hypothyroidism who have been treated with a
- •stable dose of thyroid supplement for at least the past 3 months, and
- •who are clinically and chemically euthyroid, will be allowed to
- •participate in the study.
- •*Have initiated or discontinued hormone therapy within the previous
- •3 months prior to enrollment.
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