A Phase 2a Randomized, Double-blind, Placebo-Controlled, Parallel-Group, Multi-center Study Investigating the Efficacy, Safety, and Tolerability of JNJ-42165279 in Subjects With Social Anxiety Disorder.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) Total Score
研究概览
简要总结
The purpose of this study is to investigate the efficacy of JNJ-42165279 during 12 weeks of treatment in participants with Social Anxiety Disorder (SAD).
详细描述
This is a Phase 2a randomized (study drug assigned by chance), double-blind (neither the Investigator nor the participants know about the study intervention), placebo-controlled, parallel-group, multi-center study of JNJ-42165279 in participants with social anxiety disorder. Participants will receive 25 milligram (mg) JNJ-42165279 or matching placebo orally once-daily from Day 1 up to 12 weeks. Participants will primarily be assessed for the change from baseline in Liebowitz Social Anxiety Scale (LSAS) at Week 12. Safety will be monitored throughout the study.
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
- •Must have a primary DSM-5 diagnosis of Social anxiety disorder (SAD) except those with performance only as a specifier. Participants with a diagnosis of comorbid Generalized Anxiety Disorder (GAD) or Major Depressive Disorder (MDD) may be included if the Investigator considers SAD to be the predominant diagnosis. Participants with current or lifetime history of Attention deficit hyperactivity disorder (ADHD) and specific phobia may be included as well
- •Must have a Liebowitz Social Anxiety Scale score greater than or equal (>=) 70 at Screening and Baseline
- •Participants with a current episode of MDD must have a HDRS17 total score less than or equal to (<=) 18
- •Must have a body mass index (BMI) between 18 and 35 kilogram per meter square (kg/m^2), inclusive, at screening
- •Female participants must be either postmenopausal or surgically sterile
排除标准
- •Participants who have performance only SAD are excluded. Participants with other current significant psychiatric condition(s) (Axis 1 under DSM-IV), including, but not limited to, MDD with psychotic features (lifetime), bipolar disorder (including lifetime diagnosis), obsessive-compulsive disorder, borderline personality disorder, eating disorder (e.g., bulimia, anorexia nervosa), autism spectrum disorders, post-traumatic stress disorder (PTSD) or schizophrenia are excluded. Participants with a diagnosis of comorbid GAD or MDD may be included
- •Participants is currently receiving specific psychotherapy for SAD
- •Has a history of more than two unsuccessful adequate pharmacological treatment trials for SAD, defined as lack of response to at least 10 weeks of treatment at adequate doses (e.g., paroxetine >= 40 milligram per day (mg/day) or its equivalent; or clonazepam >= 2.5 mg/day or its equivalent)
- •Concurrent use of psychotropic medications
- •has a history of or current thyroid disease, thyroid dysfunction and is currently untreated for it
研究组 & 干预措施
JNJ-42165279
Participants will receive 25 milligram (mg) JNJ-42165279 orally once-daily from Day 1 up to 12 weeks.
干预措施: JNJ-42165279 (Drug)
Placebo
Participants will receive a matching placebo orally once-daily from Day 1 up to 12 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Liebowitz Social Anxiety Scale (LSAS) Total Score
时间窗: Baseline and Week 12
The LSAS is a 24-item, semi-structured interview on the severity of Social Anxiety Disorder. The LSAS separately assesses fear and avoidance of 24 social situations. The scale is divided into 2 subscales, 13 situations concerning performance anxiety, and 11 situations pertaining to social situations. The 24 items are first rated on a Likert Scale from 0 to 3 on fear felt during the situations (0=none, 1=mild, 2=moderate, 3= severe), and then the same items are rated regarding avoidance of the situation (0=never, 1=occasionally, 2=often, 3=usually) with higher scores indicating greater social anxiety. The LSAS fear/anxiety and avoidance subscale was calculated by summing the 24 fear/anxiety and avoidance item scores of the LSAS, and ranges from 0 to 72. Combining the total scores for the Fear and Avoidance sections provides an overall score with a maximum of 144 points and a minimum of 0 points. Higher scores indicated higher probability of social anxiety disorder (SAD).
次要结局
- Change From Baseline in LSAS Fear/Anxiety and Avoidance Subscales(Baseline and Week 12)
- Change From Baseline in Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A) Total Score(Baseline and Week 12)
- Change From Baseline in Hamilton Depression Rating Scale (HDRS)-17 Total Score(Baseline and Week 12)
- Percentage of Participants With >=50% Improvement From Baseline (Responders) in SIGH-A Total Score(Baseline, Week 12)
- Percentage of Participants With Greater Than or Equal to (>=) 50 Percent (%) Improvement From Baseline (Responders) on LSAS Total Score(Week 12)
- Percentage of Participants With >=30% Improvement From Baseline (Remitters) on LSAS Total Score(Week 12)
- Change From Baseline in Hamilton Anxiety Scale (HAM)-A6 Score(Baseline and Week 12)
- Change From Baseline in HDRS17 Anxiety/Somatization Factor Total Score(Baseline and Week 12)
- Change From Baseline in HAM-D6 Total Score(Baseline and Week 12)
- Percentage of Participants With Change From Baseline in Clinical Global Impression- Improvement (CGI-I) Score(Week 12)