CAN-BIND (Canadian Biomarker Integration Network for Depression): Long-Term Follow Up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 5
- 主要终点
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) (Montgomery and Asberg 1979) scores from CAN-BIND baseline
研究概览
简要总结
The LTFU study will conduct a naturalistic follow up of the well characterized CAN-BIND study population of patients every six months and continuing over a five-year period. This will provide information on the longitudinal progress in mood, functioning, and quality of life of the CAN-BIND sample with a view towards long-term outcome and treatment.
详细描述
This is a long-term follow up study of the 'Canadian Biomarker Integration Network in Depression' (CAN-BIND) study. The CAN-BIND study examines biological markers of antidepressant treatment response. The examined biomarkers included clinical, imaging, and genetic components. The Long Term Follow up (LTFU) study will continue to follow the patients in this study each six months over a five year period. By doing so, a comprehensive clinical outcome data on a well characterized cohort of depressed patients will be obtained.
The research team will conduct a naturalistic study of CAN-BIND participants and will monitor the longitudinal progress in mood, functioning, and quality of life, with a view towards advising future treatment options. Each patient completing CAN-BIND will be asked to participate in the LTFU study.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Each patient completing the 16 weeks of CAN-BIND who have previously met DSM-IV-TR criteria for Major Depressive Episode (MDE) in MDD as determined by MINI.
排除标准
- •Any Axis I diagnosis, other than MDD, that is considered the primary diagnosis.
- •Bipolar I or Bipolar II diagnosis (lifetime), MDD with psychotic features (lifetime), schizophrenia or schizoaffective disorder.
- •Presence of a significant Axis II diagnosis (borderline, antisocial).
- •High suicidal risk, defined by clinician judgement.
- •History of drug or alcohol use, with a severity of at least moderate or severe, according to DSM criteria, within the previous 6 months.
- •Presence of significant neurologic disorder, head trauma, or other unstable medical conditions.
- •Subject has any condition, for which in the opinion of the investigator, participation would not be in the interest of the subject (e.g. compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
结局指标
主要结局
Change in Montgomery-Asberg Depression Rating Scale (MADRS) (Montgomery and Asberg 1979) scores from CAN-BIND baseline
时间窗: Every six months up to Year 5
Clinical response (equal to or greater than 50% reduction in MADRS scores from CAN-BIND baseline); Relapse is determined if the MADRS score is greater than or equal to 22 or there is suicidal ideation with intent, or suicidal behaviour.
次要结局
- Longitudinal Interval Follow-up Evaluation (LIFE) (Keller et al., 1978)(Every six months up to Year 5)
- Life Events and Difficulties Schedule (LEDS) (Brown & Harris, 1978)(Every six months up to Year 5)
研究者
Sidney Kennedy
Senior Scientist, Psychiatrist
University Health Network, Toronto