A Multi-center Randomized Double-blind Placebo-controlled Parallel-group Study to Investigate Efficacy and Safety of RO4995819 vs Placebo, as Adjunct Therapy in Patients w/Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Montgomery Asberg Depression Rating Scale
研究概览
简要总结
The purpose of the study is to explore the efficacy of 6 weeks treatment of an investigational medication, RO4995819, versus placebo as adjunctive therapy in patients with major depression.
详细描述
The investigators hope to learn the efficacy of 6 weeks treatment of RO4995819 versus placebo as adjunctive therapy in patients with MDD having inadequate response to ongoing antidepressant treatment based on mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores from baseline to end of treatment.
This knowledge is valuable because it is a new medication, which may have utility in the population of patients with major depressive disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are eligible for enrollment in this study if they meet all of the following criteria:
- •An outpatient w/a primary diagnosis of major depressive disorder w/out psychotic features
- •Inadequate response to current, ongoing antidepressant tx of SSRI/SNRI.
- •Having at least 1 but no more than 2 antidepressant treatment failures w/in the index depressive episode
- •Dose/duration of antidepressant treatment in index episode can be verified by documentation from one of following:
- •Med records;
- •Pharmacy records;
- •Treating and/or referring physician (indicating medication, dose, dates of treatment).
- •Documentation of clinical/treatment history must be available.
- •Index depressive episode started w/in 1 year of screening.
- •Confirmed compliance w/current SSRI/SNRI treatment based on blood screen.
- •Existing med regimens should be stable for 6 wks prior to screening
- •18-65 y.o. at time of consent
- •BMI 18.0 to 35.0 kg/m2 inc.
- •Patients w/reproductive potential must agree to use specified contraceptive protection during tx period and for at least 90 days after last dose of study drug:
- •Males w/partners of childbearing potential or partners must use a barrier method of contraception or remain sexually abstinent.
- •Females who are not either surgically sterile (tubal ligation, removal of ovaries or uterus) or post-menopausal (no spontaneous menstrual periods for at least 1 yr confirmed by a hormone panel [FSH and 17βestradiol])must agree to use 2 adequate methods of contraception, including at least one method w/ failure rate of < 1% per yr (e.g., hormonal implants, combined oral contraceptives, vasectomized partner, abstinence).
- •Able to participate and willing to give written informed consent.
排除标准
- •Patients are excluded from this study if the answer is 'yes' to any of the following:
- •Current and past treatment history:
- •Currently receiving tx w/3 or more antidepressants.
- •Currently receiving tx w/prohibited meds.
- •Significant ongoing use of high doses of barbiturates, benzodiazepines or other anxiolytic drugs.
- •Previously received RO
- •Participated in investigational drug or device study w/in 6 mos of screening or in index depressive episode.
- •History of non-response to Electroconvulsive Therapy (ECT), Vagus Nerve Stimulation (VNS),or Repetitive Transcranial Magnetic Stimulation (RTMS).
- •Planning to begin/change current regimen of individual psychotherapy including cognitive behavioral therapy during the 6 week treatment period of the study and the first 2 weeks of follow-up.
- •Present DSM-IV-TR axis I diagnosis except for anxiety comorbidity
- •Past or present psychotic symptoms.
- •Mood disorder due to medical condition or substance use/abuse/dependence.
- •Established personality disorder
- •Alcohol and/or substance abuse/dependence during the last 6 months.
- •A significant risk for suicidal behavior
- •Past or present neurological disorder.
- •Present eating disorder
- •Abnormal thyroid function.
- •Active upper gastrointestinal tract disease
- •Unstable medical condition that could pose unacceptable risk to the patient in this study.
- •Positive result on hepatitis B (HBV), hepatitis C (HCV), or HIV 1 and
- •Positive test for drugs of abuse.
- •Abnormality on 12-lead electrocardiogram (ECG), including a QTcF of ≥450 milliseconds.
- •Lab abnormality
- •Positive pregnancy test, breast feeding,or intention to become pregnant during the course of the trial.
研究组 & 干预措施
RO4995819 15mg
RO4995819 15mg X 6 weeks
干预措施: RO4995819 (Biological)
Placebo
Placebo X 6 weeks
干预措施: RO4995819 (Biological)
RO4995819 5mg
RO4995819 5mgX6wks
干预措施: RO4995819 (Biological)
RO4995819 30mg
RO4995819 30mg X 6 weeks
干预措施: RO4995819 (Biological)
结局指标
主要结局
Montgomery Asberg Depression Rating Scale
时间窗: 6 weeks
The investigators hope to learn the efficacy of 6 weeks treatment of RO4995819 versus placebo as adjunctive therapy in patients with MDD having inadequate response to ongoing antidepressant treatment based on mean change in Montgomery Asberg Depression Rating Scale (MADRS) scores from baseline to end of treatment. This knowledge is valuable because it is a new medication, which may have utility in the population of patients with major depressive disorder.
次要结局
未报告次要终点
研究者
Charles DeBattista
Principle Investigator
Stanford University