A Multicenter, Double-Blind, Placebo-Controlled Study of JNJ-40411813 as Adjunctive Treatment to an Antidepressant in Adults With Major Depressive Disorder With Anxiety Symptoms
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 121
- 主要终点
- The change from baseline to endpoint on the Hamilton Anxiety Rating scale (HAM-A6) score
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and overall safety and tolerability of treatment with adjunctive JNJ-40411813 compared to placebo in patients with MDD with anxiety symptoms being treated with an antidepressant.
详细描述
This is a multicenter, double-blind (neither physician nor patient knows the treatment that the patient receives), placebo-controlled study in adult patients with Major Depressive Disorder (MDD) with anxiety symptoms of relevant severity. The study will consist of 3 phases: a screening phase of up to 2 weeks, an 8-week double-blind treatment phase, and a 2-week post-treatment (follow up) phase. Patients will continue to take the same daily dose of their antidepressant (as directed by the investigator) at the same time of day, from screening through the end of the study, including the post-treatment phase. The total study duration for each patient will be approximately 12 weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Major Depressive Disorder (MDD); patients with a diagnosis of comorbid Generalized Anxiety Disorder, Social Anxiety Disorder, or Panic Disorder may be included, if the investigator considers MDD to be the primary diagnosis
- •A 17-item Hamilton Depression Rating Scale (HDRS17) total score =>18
- •A HDRS17 anxiety/somatization factor score =>7
- •Is receiving an antidepressant
排除标准
- •Has other psychiatric condition, including, but not limited to, MDD with psychotic features, bipolar disorder, obsessive-compulsive disorder, post-traumatic stress disorder, borderline personality disorder, eating disorder, or schizophrenia
- •Has a length of current Major Depressive Episode (MDE) >6 months
- •Has a current or recent history of clinically significant suicidal ideation within the past 6 months, or a history of suicidal behavior within the past year
- •Not including the inadequate response to the current antidepressant, has more than 1 failed antidepressant treatment of adequate dose and duration in the current MDE
研究组 & 干预措施
JNJ-40411813
干预措施: JNJ-40411813 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
The change from baseline to endpoint on the Hamilton Anxiety Rating scale (HAM-A6) score
时间窗: Baseline, Week 4
The HAM-A6 is a 6-item subscale derived from the original Hamilton Anxiety scale (HAM-A). The rating scale measures the severity of anxiety symptomatology. Higher scores represent more severe anxiety symptoms.
次要结局
- The change from baseline to endpoint in the Clinical Global Impression - Improvement (CGI-I) scale(Baseline, Week 4)
- The change from baseline to endpoint on the Hamilton Depression Rating Scale (HDRS17) total score(Baseline, Week 4)
- The change from baseline to endpoint on the SIGH-A (Structured Interview Guide of the Hamilton Anxiety Scale 14-item HAM-A) total score(Baseline, Week 4)
- The change from baseline to endpoint in the Hamilton Depression Rating Scale (HDRS17) anxiety/somatization factor total score(Baseline, Week 4)
- The change from baseline to endpoint in the HAM-D6 score(Baseline, Week 4)
- The change from baseline to endpoint in the Inventory of Depressive Symptomatolgy -Clinician rated (IDS-C30) total score(Baseline, Week 6)
- The change from baseline to endpoint in the Inventory of Depressive Symptomatology - Clinician-Rated (IDS-C30) anxiety subscale(Baseline, Week 4)
- The change from baseline to Week 4 in the Work Limitations Questionnaire (WLQ)(Baseline, Week 4)
- The change from baseline to endpoint on the Perceived Stress Scale (PSS)(Baseline, Week 4)
- The change from baseline to endpoint in the Profile of Moods Scale-Brief Form (POMS-BF)(Baseline, Week 4)
- The change from baseline to endpoint on the Medical Outcomes Study- 12-item Sleep Scale Acute - Revised (MOS Sleep-R)(Baseline, Week 4)
- The number of patients with a Hamilton Depression Rating Scale (HDRS17) anxiety/somatization factor score ≥7 at Week 4(Week 4)
- The number and percentage of patients with either ≥50% or ≥30% improvement on the HDRS17 total score at Week 4, and number and percentage of patients with HDRS 17 total score ≤ 7 at week 4(Week 4)
- The number of patients at Week 4 with ≥ 50% improvement on the SIGH-A (Structured Interview Guide of the Hamilton Anxiety Scale 14-item HAM-A) total score(Week 4)