NCT01155661已完成3 期
Long-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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 608
- 试验地点
- 1
- 主要终点
- The Number of Participants Experiencing Clinically Significant Effects
研究概览
简要总结
The primary objective of this study is to evaluate the long-term safety and tolerability of LY2216684 administered once daily (QD) in the adjunctive treatment with a selective serotonin reuptake inhibitor (SSRI) for up to approximately 1 year in participants with major depressive disorder (MDD) who are partial responders to their SSRI treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults competent and able to give informed consent
- •Women of child-bearing potential may participate but must test negative for pregnancy at the time of study entry; both women/men agree to use a reliable method of birth control
- •Participants who are being treated with one of the following selective serotonin reuptake inhibitors (SSRIs): escitalopram, citalopram, sertraline, fluoxetine, paroxetine, and fluvoxamine; for at least 6 weeks prior to investigational product dispensing with at least the last 4 weeks at a stable, optimized dose
- •Drug and dosage should be within the labeling guidelines for the specific country
- •Meet criteria for Major Depressive Disorder (MDD), as defined by the Diagnostic and Statistical Manual, Fourth Edition, Text Revision (DSM-IV-TR) criteria
- •Meet criteria for partial response, as defined by investigator's opinion that participant has experienced a minimal clinically meaningful improvement with SSRI
- •Have a Grid Hamilton Rating Scale for Depression (GRID-HAMD17) total score greater than or equal to 16 at screening
- •Have less than or equal to 75 percent improvement on the current SSRI at screening determined by the Massachusetts General Hospital Antidepressant Response Questionnaire (MGH-ATRQ)
- •Meet all other inclusion criteria per protocol
排除标准
- •Presence of another primary psychiatric illnesses:
- •Have had or currently have any additional ongoing DSM-IV-TR Axis I 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 DSM-IV-TR), not including caffeine and nicotine
- •Have a DSM-IV-TR Axis II disorder that, in the judgment of the investigator, would interfere with compliance with protocol
- •Unstable medical conditions that contraindicate the use of LY2216684
- •Have any diagnosed medical condition which could be exacerbated by noradrenergic agents including unstable hypertension, unstable heart disease, tachycardia, tachyarrhythmia, narrow-angled glaucoma, 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 of prior to enrollment
- •History of treatment resistant depression as shown by:
- •Have had 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 participant has treatment-resistant depression
- •Have a history of electroconvulsive therapy, transcranial magnetic stimulation, or psychosurgery within the last year
- •Meet any other exclusion criteria per protocol
研究组 & 干预措施
LY2216684 (edivoxetine) + SSRI
Experimental
干预措施: LY2216684 (edivoxetine) (Drug)
LY2216684 (edivoxetine) + SSRI
Experimental
干预措施: SSRI (Drug)
结局指标
主要结局
The Number of Participants Experiencing Clinically Significant Effects
时间窗: Baseline through 54 weeks
A clinically significant effect was defined as a serious adverse event, regardless of causality. A summary of serious and all other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.
次要结局
- Change From Baseline to 54 Week Endpoint in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)(Baseline, Week 54)
- Change From Baseline to 54 Week Endpoint in the Arizona Sexual Experiences (ASEX) Scale(Baseline, Week 54)
- Change From Baseline to 54 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Items(Baseline, Week 54)
- Change From Baseline to 54 Week Endpoint in Clinical Global Impression - Severity (CGI-S)(Baseline, Week 54)
- Change From Baseline to 54 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) Depression Subscale Score(Baseline, Week 54)
- Percent of Participants With Suicidal Ideation and Behavior Based on the Columbia-Suicide Severity Rating Scale (C-SSRS)(Baseline through Week 54)
- Change From Baseline to 54 Week Endpoint in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)(Baseline, Week 54)
- Percentage of Participants Who Reported Resource Utilization (RU) at Baseline and at the Week 54 Endpoint(Baseline, Week 54)
- Probability of Meeting the Remission Criteria for Depressive Symptoms at Week 54 Endpoint(Baseline, Week 54)
- Change From Baseline to 54 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscores(Baseline, Week 54)
- Change From Baseline to 54 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score(Baseline, Week 54)
- Change From Baseline to 54 Week Endpoint in EuroQol Questionnaire - 5 Dimension (EQ-5D)(Baseline, Week 54)
- Percentage of Participants With Discontinuation-Emergent Adverse Events (DEAEs)(Up to1 week after discontinuation of treatment)
- Change From Baseline to Week 54 Endpoint in Pulse Rate(Baseline, Week 54)
- Probability of Meeting the Response Criteria for Depressive Symptoms at Week 54 Endpoint(Baseline, Week 54)
- Change From Baseline to 54 Week Endpoint in Blood Pressure(Baseline, Week 54)
- Change From Baseline to 54 Week Endpoint in Fatigue Associated With Depression (FAsD) Average Score and Subscale Scores(Baseline, Week 54)
- Percentage of Participants Who Meet Response Criteria of Depressive Symptoms by Week 8(Baseline, Week 8)
- Percentage of Participants Who Meet Remission Criteria of Depressive Symptoms by Week 8(Baseline, Week 8)
- Plasma Concentration of LY2216684(Weeks 2, 6, and 8)
- The Number of Participants Experiencing Clinically Significant Effects as a Function of CYP2D6 Predicted Phenotype at Week 54 Endpoint(Baseline, Week 54)
研究者
研究点 (1)
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