Long-Term Follow Up Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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CAN-BIND (Canadian Biomarker Integration Network for Depression): Long-Term Follow Up Study

Conditions
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Major Depressive Disorder

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) (Montgomery and Asberg 1979) scores from CAN-BIND baseline | 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. | Every six months up to Year 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Longitudinal Interval Follow-up Evaluation (LIFE) (Keller et al., 1978) | The LIFE is a clinician-rated interview that provides a structure for collecting and coding data on the longitudinal course of psychopathology. It allows for precise dating of onset and offset of symptoms (including sub-syndromal symptoms) and ranks severity on a week by week basis. | Every six months up to Year 5 | 
| Life Events and Difficulties Schedule (LEDS) (Brown & Harris, 1978) | The LEDS is a semi-structured interview that collects detailed contextual information regarding acute stressful life events and chronic difficulties in several domains. | Every six months up to Year 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biomarkers, MDD, major depression, major depressive disorder, long term follow up