NCT04748276招募中不适用
Tracking Response to Antidepressants in Advance of Investigational Trials
Adams Clinical1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2019年1月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Change in Hamilton Depression Inventory - 17 item (HAM-D) total score in response to a treatment cycle from Baseline/Day 0 to the end of a 6-week treatment cycle.
研究概览
简要总结
TRAIT is an open-label observational study to evaluate treatment response to selective-serotonin reuptake inhibitors (SSRIs) and selective-norepinephrine reuptake inhibitors (SNRIs) among individuals meeting criteria for Major Depressive Disorder (MDD) and seeking enrollment in investigational trials.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Participant has signed an ICF prior to any study-specific procedures being performed.
- •Participant is male or female of age ≥ 18 years old.
- •Participant has a diagnosis of MDD as confirmed by the MINI semi-structured diagnostic interview and ≥ 14 HAM-D total score.
- •Participant is in good physical health and, in the opinion of the investigator, is a suitable candidate for treatment with an ADT.
排除标准
- •Participant is pregnant, breast-feeding, or planning to become pregnant.
- •A history or presence of a clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality, which in the opinion of the investigator may impact participant safety or study results.
- •Participant has a history of any psychiatric condition other than MDD, which in the opinion of the investigator is primary, or any other psychiatric or neurologic disorder or symptom that could pose undue risk to the participant or compromise the study.
- •Any participant who represents an acute suicidal risk in the opinion of the investigator.
- •Moderate or severe substance use disorder within 90 days prior to screen, according to DSM-5 criteria that in the opinion of the investigator could pose undue risk to the participant, or compromise the study.
- •Any condition that, in the opinion of the investigator, makes the participant unsuitable for the study.
结局指标
主要结局
Change in Hamilton Depression Inventory - 17 item (HAM-D) total score in response to a treatment cycle from Baseline/Day 0 to the end of a 6-week treatment cycle.
时间窗: Up to 33 weeks
次要结局
- Partial response to 1, 2, or 3+ ADT treatment cycles, as defined as ≥ 25% to < 50% change in HAM-D total score from study Baseline/Day 0 to Day 42 of the participant's 1st, 2nd, or 3rd+ treatment cycles.(Up to 33 weeks)
- Total number of treatment cycles required to reach ADT response, as defined as ≥ 50% reduction in HAM-D score from Baseline/Day 0 to Day 42 of each treatment cycle.(Up to 33 weeks)
- Failure to respond to 1, 2, or 3+ ADT treatment cycles, as defined as < 25% change in HAM-D total score from study Baseline/Day 0 to Day 42 of the participant's 1st, 2nd, or 3rd+ treatment cycles.(Up to 33 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Tracking Response to Antidepressants in Advance of Investigational Trials, Relapse StudyMajor Depressive DisorderNCT04933630Adams Clinical27
已完成
4 期
A Placebo-Controlled Study to Investigate the Onset of Action of Paroxetine in Premenstrual DysphoriaPremenstrual SyndromePremenstrual Dysphoric DisorderNCT00516113Karolinska Institutet24
已完成
4 期
Effectiveness Study of Mirtazapine Combined With Paroxetine in Major Depressive Patients Without Early ImprovementMajor DepressionNCT01458626Capital Medical University525
已完成
4 期
Switching From an SSRI to Tiagabine(GABITRIL) in Order to Alleviate SSRI Induced Sexual DysfunctionSexual DysfunctionAnxietyNCT00174850State University of New York - Upstate Medical University30
Unknown
4 期
DECARD: Study of Escitalopram in the Prevention of Depression in Patients With Acute Coronary SyndromeDepressionNCT00140257Bispebjerg Hospital240