ong-Term, Open-Label, Safety Study of LY2216684 12 to 18 mg Once Daily as Adjunctive Treatment for Patients with Major Depressive Disorder Who are Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment - LNBO 219-381

Eli Lilly0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年5月6日

研究概览

暂无简介。

•Male and female, adult outpatients aged *18 years who meet DSM-IV-TR diagnostic criteria for MDD as determined by clinical assessment by the Mini-International Neuropsychiatric Interview (MINI) and confirmed by the physician and who have experienced a partial treatment response to a course of SSRI treatment for at least 6 weeks with at least the last 4 consecutive weeks at a stable, optimized dose prior to Visit 2. Patients must have a score *16 on the GRID 17-Item Hamilton Rating Scale for Depression (GRID HAMD17) total score at Visit 1 and Visit 2. Patients will be determined to be partial responders by history, by the opinion of the investigator. Patients will also be required to have a rating indicating *75% improvement for their current SSRI treatment using the Massachusetts General Hospital Antidepressant Treatment Response Questionnaire (MGH-ATRQ) at Visit 1.

•Exclusion criteria include any additional DSM-IV-TR Axis I condition other than major depression that was considered the primary diagnosis within 1 year of Visit 1; other primary Axis I anxiety 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); current or previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder; have a serious or unstable medical condition; have any diagnosed medical condition that could be exacerbated by noradrenergic agents, including unstable hypertension, unstable heart disease, tachycardia or tachyarrhythmia, narrow-angle glaucoma, or history of urinary hesitation or retention; use of excluded concomitant medication; serious ideation/risk for harm to self or others; and pregnancy or breastfeeding status.

发起方