Long-Term, Open-Label, Safety Study of LY2216684 12 to 18 mg Once Daily as Adjunctive Treatment for Adult Patients With Major Depressive Disorder Who Were Partial Responders to Selective Serotonin Reuptake Inhibitor Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Number of Participants With Clinically Significant Events
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 in the adjunctive treatment with an Selective Serotonin Reuptake Inhibitors (SSRI) for up to approximately 1 year in participants with Major Depressive Disorder (MDD) who were 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
- •Participants must have completed Study LNBM: NCT01173601 or Study LNBQ: NCT01187407
- •Participants must be competent and able to give their own informed consent
排除标准
- •Participants that have had or currently have any additional ongoing Diagnostic and Statistical Manual of Mental Disorder, fourth edition, text revision (DSM-IV-TR) Axis I condition other than major depression that was considered the primary diagnosis within 1 year of entering trial
- •Participants that have had any anxiety disorder that was considered a primary diagnosis within the past year
- •Participants that have a current or previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder
- •Participants that have a history of substance abuse within the past 1 year, and/or substance dependence within the past 1 year, not including caffeine and nicotine
- •Participants that have an Axis II disorder that, in the judgment of the investigator, would interfere with compliance with the study
- •Participants that 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, the participant has treatment-resistant depression
- •Participants that have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or psychosurgery within the last year
- •Participants who are women who are pregnant or breastfeeding
- •Participants who, in the opinion of the investigator, are judged to be at serious risk for harm to self or others
- •Participants that have a serious or unstable medical illness
- •Participants that have any diagnosed medical condition which could be exacerbated by noradrenergic agents
- •Participants that have a history of severe allergies to more than 1 class of medication or multiple adverse drug reactions
- •Participants that have a history of any seizure disorder (other than febrile seizures)
- •Participants that have received treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to entering trial or have a potential need to use an MAOI within 3 days after discontinuation from the study
- •Participants that require psychotropic medication other than sedative/hypnotic medication for sleep
- •Participants who are taking or have received treatment with any excluded medications within 7 days prior to entering trial
- •Participants that have a thyroid stimulating hormone (TSH) level outside the laboratory established reference range. Participants 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.
- •Participants that have initiated or discontinued hormone therapy within the previous 3 months prior to enrollment
- •Participants that have initiated psychotherapy, change in intensity of psychotherapy or other nondrug therapies (such as acupuncture or hypnosis) within 6 weeks prior to enrollment or at any time during the study.
- •Participants have a positive urine drug screen (UDS) for any substances of abuse on entering trial
- •Participants have significantly violated rules that a participant must comply with during Study LNBM: NCT01173601 or Study LNBQ: NCT01187407
研究组 & 干预措施
LY2216684 + SSRI
LY2216684: 12 milligrams (mg) or 18 mg, administered orally, once daily for 52 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI).
During the open-label phase, all participants started at the 12 mg dose and could have the dose increased to 18 mg after the first week of treatment. During the first 12 weeks, participants were allowed (at scheduled or unscheduled visits) to decrease their dose to 12 mg based on response. After a decrease in dose to 12 mg, participants could have had an increase back up to 18 mg at any scheduled visit based on response and tolerability. After 12 weeks of treatment, participants maintained a stable dose.
Open-label treatment was followed by a 1-week abrupt discontinuation phase. Participants who either completed study visits through Week 52 or discontinued early from the study for any reason returned 1 week later for follow-up visit. Participants did not receive LY2216684 but continued their SSRI treatment at a stable dose.
干预措施: LY2216684 (Drug)
LY2216684 + SSRI
LY2216684: 12 milligrams (mg) or 18 mg, administered orally, once daily for 52 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI).
During the open-label phase, all participants started at the 12 mg dose and could have the dose increased to 18 mg after the first week of treatment. During the first 12 weeks, participants were allowed (at scheduled or unscheduled visits) to decrease their dose to 12 mg based on response. After a decrease in dose to 12 mg, participants could have had an increase back up to 18 mg at any scheduled visit based on response and tolerability. After 12 weeks of treatment, participants maintained a stable dose.
Open-label treatment was followed by a 1-week abrupt discontinuation phase. Participants who either completed study visits through Week 52 or discontinued early from the study for any reason returned 1 week later for follow-up visit. Participants did not receive LY2216684 but continued their SSRI treatment at a stable dose.
干预措施: SSRI (Drug)
结局指标
主要结局
Number of Participants With Clinically Significant Events
时间窗: Baseline through 52 weeks
Clinically significant events were defined as serious adverse events, regardless of causality. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module.
次要结局
- Percentage of Participants With Suicidal Behaviors and Ideations Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)(Baseline through 52 weeks)
- Change From Baseline to 52 Week Endpoint in Arizona Sexual Experiences (ASEX) Scale(Baseline, 52 weeks)
- Change From Baseline to 52 Week Endpoint in Clinical Global Impression - Severity (CGI-S)(Baseline, 52 weeks)
- Change From Baseline to 52 Week Endpoint in Sheehan Disability Scale (SDS) Total Score and Subscale Scores(Baseline, 52 weeks)
- Change From Baseline to 52 Week Endpoint in EuroQol Questionnaire - 5 Dimension (EQ-5D)(Baseline, 52 weeks)
- Change From Baseline to 52 Week Endpoint in Blood Pressure(Baseline, 52 weeks)
- Change From Baseline to 52 Week Endpoint in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF)(Baseline, 52 weeks)
- Change From Baseline to 52 Week Endpoint in Pulse Rate(Baseline, 52 weeks)
- Change From Baseline to 52 Week Endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Individual Items(Baseline, 52 weeks)
- Change From Baseline to 52 Week Endpoint in Fatigue Associated With Depression (FAsD) Average Score and Subscale Scores(Baseline, 52 weeks)
- Change From Baseline to 52 Week Endpoint in Hospital Anxiety and Depression Scale (HADS) Depression and Anxiety Subscale Scores(Baseline, 52 weeks)
- Change From Baseline to 52 Week Endpoint in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ)(Baseline, 52 weeks)