NCT04933630已完成不适用
Tracking Response to Antidepressants in Advance of Investigational Trials, Relapse Study
Adams Clinical1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2021年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- Stability of treatment response as defined as change in self-report PHQ-9 total scores during the observational period from Baseline/Day 0 to End of Study (EOS)/Day 365.
研究概览
简要总结
TRAIT-RS is an observational study to evaluate ongoing treatment response stability to standard of care antidepressant treatments (ADTs) among individuals who met criteria for Major Depressive Disorder (MDD) and completed the Tracking Response to Antidepressants in Advance of Investigational Trials (TRAIT) study (NCT04748276).
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 completed the TRAIT study and, in the opinion of the investigator, would benefit from ongoing depression monitoring and/or ADT treatment.
- •Participant has signed an ICF prior to any study-specific procedures being performed.
- •Participant is male or female of age ≥ 18 years.
- •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
Stability of treatment response as defined as change in self-report PHQ-9 total scores during the observational period from Baseline/Day 0 to End of Study (EOS)/Day 365.
时间窗: Up to 52 weeks
次要结局
- The number of participants who maintain ADT compliance as defined as ≥ 80% average monthly adherence during the observational period.(Up to 52 weeks)
- The number of participants who meet MDD relapse criteria as defined as the higher of a) PHQ-9 score ≥ 10, or b) ≥ 50% increase in PHQ-9 score from Baseline/Day 0, and verified by clinician-rated assessment as indicated by a HAM-D score ≥ 14 and CGI ≥ 4.(Up to 52 weeks)
研究者
研究点 (1)
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