Long-Term Follow Up Study

Sidney Kennedy96 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Major Depressive Disorder

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (5)

University of Calgary

Calgary, Alberta, Canada

University of British Columbia

Vancouver, British Columbia, Canada

McMaster University

Hamilton, Ontario, Canada

Queen's University

Kingston, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: Every six months up to Year 5

Secondary Outcomes

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.

Time frame: 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.

Time frame: Every six months up to Year 5

Data from ClinicalTrials.gov

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