EUCTR2019-001683-29-GB进行中（未招募）1 期
Double-Blind, Placebo-Controlled, Multi-Center Study Investigating the Efficacy, Safety, and Tolerability of JNJ-61393215 as Adjunctive Treatment in Adults with Major Depressive Disorder with Anxious Distress with Suboptimal Response to Standard Antidepressants
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 218
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Male and female participants between 18 and 64 years of age, inclusive.
- •2. Participants must have a primary DSM-5 diagnosis of MDD with anxious distress, as assessed by the MINI 7.0. Plus (with module for MDD with anxious distress). Participants with a diagnosis of comorbid Generalized Anxiety Disorder (GAD), Post Traumatic Stress Disorder, Persistent Depressive Disorder, Attention Deficit Hyperactivity Disorder (ADHD), Social Anxiety Disorder or Nicotine/Caffeine Dependence may be included, if the investigator considers MDD to be the primary diagnosis. Participants with Panic Disorder with or without agoraphobia may be included if the Panic Disorder diagnosis is primary.
- •3. Participants must have an IDS-C30 total score =35 (moderate to severe depression) at screening, as confirmed by the SAFER independent rater.
- •4. Participant must have an IDS-C30 score for item 26 or 27 (symptoms of somatic anxiety) =2 at screening, as confirmed by the SAFER independent rater.
- •5. Participant must not have received more than 3 failed antidepressant treatments (of adequate dose and duration), including their current treatment, in the current episode of depression, as documented by the MGH ATRQ.
- •Please see protocol for remaining inclusion criteria.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 218
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Participant has any other current Axis I psychiatric condition, including, but not limited to, MDD with current psychotic features, bipolar disorder (including lifetime diagnosis), obsessive compulsive disorder, borderline personality disorder, eating disorder (e.g., bulimia, anorexia nervosa), or schizophrenia (lifetime). As noted above, participants with a diagnosis of comorbid GAD, Post Traumatic Stress Disorder, Persistent Depressive Disorder, ADHD, Social Anxiety Disorder, or Nicotine/Caffeine Dependence may be included, if the investigator considers MDD to be the primary diagnosis. Participants with Panic Disorder with or without agoraphobia may be included if the Panic Disorder diagnosis is primary.
- •2. Participant has an age of onset of depression after 55 years of age.
- •3. Participant has a current or recent (within the past year) history of clinically significant suicidal ideation (corresponding to a score of = 3 for ideation) or any suicidal behavior within the past year, as validated on the C-SSRS at screening or baseline. Participants with a prior suicide attempt of any sort, or history of prior serious suicidal ideation/plan should be carefully screened for current suicidal ideation and only included at the discretion of the investigator.
- •4. Length of current major depressive episode > 60 months.
- •5. Participant has organic brain disease or dementia.
- •Please see protocol for remaining exclusion criteria.
研究者
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